Biomedical Business & Technology

Xcorporeal (Los Angeles) reported that data from a pilot study using its Wearable Artificial Kidney (WAK) prototype — which allows patients with end-stage kidney failure to have their blood cleansed around the clock — indicate that this dialysis device could be more effective than conventional hemodialysis therapy.

"Every patient on dialysis undergoes blood filtration for nine to 12 hours a week," Victor Gura, MD, Xcorporeal's chief scientific and medical officer told Biomedical Business & Technology. "Mortality is high. There is mounting evidence that if you increase the amount of dialysis time you give the patient — not the efficiency or type to dialysis, but the time — you improve outcomes greatly. Everybody should be dialyzing longer and more often.

The pilot study was conducted by Gura and Andrew Davenport, MD, at the Royal Free and University College Hospital Medical School (London). The data provide preliminary indications on the safety features of the WAK and give Xcorporeal the impetus to move forward with larger studies.

The WAK is a battery-powered, wearable dialysis machine that allows users to move about freely instead of being tethered to conventional dialysis machines. The device straps to a belt and is hooked to the bloodstream through a catheter implanted in the patient's chest. The catheter is tunneled under the skin and exits above the waist.

"We had no complications whatsoever," Gura said. "Every patient felt very well and there were no side effects."

End-stage kidney disease is a complete or near-complete failure of the kidneys to function to excrete wastes, concentrate urine, and regulate electrolytes. In the U.S., more than 400,000 people are on long-term dialysis and more than 20,000 have a functioning transplanted kidney. The most common cause of renal failure in the U.S. is diabetes.

Gura, who invented the device, said, "The hope and desire to have a wearable artificial kidney has been around for years, but until now, nobody has been able to develop it. The need for it changed when we started to understand that if we want people to survive, we need to give them daily dialysis. But we don't have enough dialysis units to provide this much dialysis. A lot of issues prompted me to develop the WAK."

Xcorporeal is testing the WAK in Europe and will likely commercialize it there first due to more lenient regulatory protocols than in the U.S., Gura said. The FDA will likely require a PMA application with an approximate two-year review process. Despite the initial efforts in Europe, the company forecasts the WAK may be on the market in the U.S. within five years.

As part of the WAK pilot study, eight patients with end-stage kidney failure who were established on regular hemodialysis were fitted with the WAK for four to eight hours. Patients were given unfractionated heparin for anticoagulation, as they would be for standard hemodialysis. There were no significant cardiovascular changes and no adverse changes in serum electrolytes or acid-base balance.

Clotting of the vascular access occurred in two patients when the dose of heparin was decreased and the partial thromboplastin time returned towards the normal reference range in both of these patients, according to the study.

Gura said future trial plans have not yet been developed. "We're still working with the prototype," he said. "It's a little bulkier and heavier, but it will be less and less of a problem. Patients were able to sleep, walk and all patients said they would recommend the device to others who needed it."

Earlier this year, Xcorporeal and CT Holdings Enterprises (Dallas) executed a definitive merger agreement. In the deal, a reverse triangular merger, Xcorporeal emerged as the surviving entity.

On Nov. 20 and Dec. 13, 2006, Xcorporeal issued shares of its common stock at a price of $7 per share in private placements to about 100 institutional and accredited investors for gross proceeds of about $29.4 million.

CT Holdings formerly operated as a business development firm providing capital and management expertise to start-up ventures.

Four products that Xcorporeal plans to market are a hospital congestive heart failure (CHF) device; a hospital renal replacement device; a portable home hemodialysis device; and the WAK. Xcorporeal plans to commercialize the CHF device in the latter half of 2008 and the renal replacement device in the first half of 2009.

The company' stock commenced trading on the American Stock Exchange on Dec. 7, under the ticker symbol XCR.

Elsewhere in the product pipeline:

• Agendia (Amsterdam, The Netherlands) said it has made its breast cancer prognosis test, MammaPrint, available to U.S. patients after receiving two clearances from the FDA. The first in February cleared MammaPrint as an in vitro diagnostic multivariate index assay for use in breast cancer prognosis. In June, Agendia received a second clearance for the test in conjunction with RNARetain, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling. "We are very pleased to make MammaPrint widely available to U.S. patients and their physicians," said Bernhard Sixt, CEO and co-founder of Agendia. MammaPrint is a DNA micro array-based in vitro diagnostic laboratory service that measures the activity of 70 genes, providing information about the likelihood of tumor recurrence.

• Amedica (Salt Lake City), an orthopedic implants company focused on silicon nitride ceramic technologies, said the FDA has granted a special 510(k) marketing clearance for the Valeo ceramic VBR spinal implant. The implant is intended for vertebral body replacement to aid in surgical correction and stabilization of the thoracolumbar spine. It incorporates Amedica's silicon nitride ceramic, which provides new functionalities compared to other devices on the market. The implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spine, even in the absence of fusion, for a prolonged period of time. "This is an important alternative to spine implants made from titanium and PEEK, as well as bone grafts taken from human cadavers," said Darrel Brodke, MD, associate professor in the department of orthopedic surgery at the University of Utah School of Medicine and chief of the spine service and medical director of the University Spine Center.

• Baxa (Englewood, Colorado) reported launch of the Repeater Pump II, designed to provide accurate delivery of pharmacy solutions into a variety of containers, without the need for calibration. The pump is a no-calibration pharmacy pump, and uses a fixed-volume pumping design commonly referred to as 'positive displacement.' The positive displacement nature of the pump eliminates the need for calibration or adjustment, providing accurate liquid delivery regardless of source container, final container, tubing diameter and fluid viscosity. The Repeater Pump II uses a number of features that have been designed through user feedback and customer preference trials. These include snap-and-go tubeset installation and memory field recalls at the touch of a button, which makes it easy to get started and repeat common applications. Additionally, Baxa has launched its MedBoard Web-based medication tracking system, designed to record pharmacy preparation and delivery activities. MedBoard helps reduce time spent fielding nursing calls and tracking order status. The system requires only a Web browser and handheld scanners to get started. Once the user-customizable features have been determined, developers configure the handheld devices to include the facility's specific rules, lists and users. MedBoard employs technical, administrative and policy safeguards to ensure data security and is HIPAA compliant. Baxa is a provider of technologies for fluid handling and delivery.

• Biosense Webster (Diamond Bar, California) reported availability of its Cartosound Image Integration module with the new Soundstar 3-D catheter that can be used with the Carto XP Navigation System. The Cartosound module integrates real time intracardiac echocardiography (ICE) images from the Siemens AcusonSequoia and Cypress ultrasound systems using the Soundstar 3-D catheter with the Carto XP EP Navigation System. The ultrasound catheter uses an embedded position sensor to display location and beam orientation on the Carto XP system, Biosense said, which enhances visualization of ICE images and ablation catheter location. According to the company, using the Cartosound module with the Soundstar 3-D catheter in conjunction with the Cartomerge Image Integration module combines the anatomic details of a pre-acquired CT or MRI image with real time ICE. Biosense, a Johnson & Johnson (New Brunswick, New Jersey) company, is a provider of diagnostic, therapeutic, and mapping tools.

• Berlin Heart (Berlin) reported the first patient enrollment in the prospective IDE study for its Excor Pediatric VAD, a mechanical cardiac support system for critically ill Pediatric patients suffering from severe heart failure. The multi-center IDE study is to evaluate the safety and probable benefit of using the Excor Pediatric VAD to support Pediatric patients. Excor Pediatric has been designed as a bridge to transplantation for patients waiting for a suitable donor heart, but has also been used as a bridge to recovery when a patient's heart was able to recover and work on its own again. Unlike standard heart-lung machines, Excor Pediatric has been used as a medium- to long-term support system, supporting failing hearts for up to several months. Berlin Heart makes pumps, cannulas, and external components for internal and external use to stabilize cardiac activity in acutely ill patients.

• Biolog (Hayward, California) reported the launch of its 3rd generation microbial ID system. The new GEN III system is built around a single test panel that can be used to identify more than 1,000 species of Gram-negative and Gram-positive bacteria. Set-up consists of a simple, one-minute protocol and no Gram-stain, pre-tests or follow-on tests are required. Previous Biolog ID systems identified 800 species and used two panels, one for gram negative bacteria and a different panel for gram positive bacteria. Bacterial ID systems from other companies use 2 or more panels and identify only about 300 species. The 96-well GEN III MicroPlate panel incorporates 71 carbon source and 23 chemical sensitivity assays in a pre-coated dry chemistry format. With these 94 tests, the system analyzes a bacterial cell's properties including its ability to metabolize all major classes of biochemicals and its sensitivity to chemicals that may inhibit growth. The colorimetric pattern or "fingerprint" generated by the bacterium is automatically interpreted against GEN III's extensive species library. Biolog makes cell analysis tools.

• Researchers said they were able to record and monitor brain electrical activity with improved precision and detect micro-seizure activity in advance of larger epileptic seizures among patients implanted with Cyberkinetics' (Foxborough, Massachusetts) NeuroPort neural monitoring system. Using the NeuroPort, they said they were able to record and monitor brain electrical activity with higher fidelity than possible with other recording technologies; detect micro-seizures and micro-discharges in patients with epilepsy that may play a role in the genesis of their seizures, but that are not detectible by scalp or standard electrodes placed directly on the brain; and correlate this micro-activity to the onset of significant epileptic seizure activity. The NeuroPort is indicated for the temporary (less than 30 days) recording and monitoring of brain electrical activity. It consists of a 4 x 4 mm, 100-microelectrode array and a signal processor. The array is implanted on the surface of the brain where the electrodes sense electrical activity from individual and groups of neurons. Cyberkinetics makes neural stimulation, sensing and processing technology to improve the lives of those with severe paralysis resulting from spinal cord injuries, neurological disorders and other conditions of the nervous system.

• Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) reported that it has received a letter from the FDA requesting additional analyses and data regarding its Humanitarian Device Exemption (HDE) marketing application for the Andara OFS (Oscillating Field Stimulator) System, a nerve growth stimulator designed as a treatment for acute spinal cord injuries. Based on the FDA's request for additional data and analyses, Cyberkinetics now expects that approval of its Andara OFS System for the treatment of acute spinal cord injury may be delayed until at least the first half of 2008. The Andara OFS System is intended as a treatment option for people with acute spinal cord injuries. The device is designed to be implanted in patients within 18 days following a spinal cord injury to stimulate nerves to grow across the area of injury. Though the device is removed after 15 weeks of treatment, improvement in both sensory and motor function may continue for months, even years, as nerves form new connections to transmit information to and from the brain.

• Cytori Therapeutics (San Diego) received 510(k) regulatory clearance from the FDA for the Cytori Autologous Fat Transfer (AFT) System. This system may be used to harvest, filter, and transfer a patient's own adipose tissue from one part of a patient's body to another at the point-of-care in the same surgical procedure. "This is an important regulatory clearance toward a more comprehensive adipose tissue processing system," said CEO Christopher Calhoun. "The key attribute of this device is its ability to optimize the preparation of adipose tissue before it is transferred back into the patient." The Cytori AFT System is intended for use in plastic and reconstructive surgery, general surgery, neurosurgery, gastrointestinal surgery, urological surgery, orthopedic surgery, gynecological surgery, thoracic surgery and laparoscopic surgery.

• Devax (Lake Forest, California), which develops interventional cardiology devices, said it has completed patient enrollment in the DIVERGE clinical trial evaluating its Axxess Bifurcation Stent System. DIVERGE, a prospective, multi-center trial which enrolled 302 patients, is the largest study conducted to date with a drug-eluting stent (DES) specifically designed for treating bifurcation lesions, areas of atherosclerotic disease occurring at a location where one large vessel divides into two smaller vessels, which may occur in about 20% of all patients undergoing a stenting procedure worldwide. Devas said that, to date, more than 500 patients worldwide have been treated using the Axxess Bifurcation Stent System. More than 400 patients have received the DES version of the stent.

• DT Research (San Jose, California) reported the availability of three new hardware applications for the WebDT mobile tablet line. The WebDT 310 and 360 are the first mobile tablets that can be ordered with an integrated barcode scanner, magnetic stripe reader and/or camera. WebDT mobile tablets are available with any combination of the three new hardware applications. Data is automatically captured and then saved directly into the commercial application on the tablet, without requiring additional steps. The devices are available in 8.4-inch (WebDT 360) and 10.4-inch (WebDT 310) touch screen displays which feature flash-based storage and extendable, hot-swappable batteries. DT Research makes information appliances for vertical markets.

• Echo Therapeutics (Franklin, Massachusetts) said that it has started the second clinical study of its current Symphony continuous transdermal glucose monitoring system (CTGM System) at the Tufts-New England Medical Center. The company said it expects to report the results of the study this quarter. Echo's current generation Symphony CTGM system consists of the FDA-cleared SonoPrep skin permeation device that incorporates permeation control technology, together with wireless conductivity and proprietary transdermal sensor technologies. In addition to providing glucose monitoring benefits to diabetes patients, Symphony is designed to help patients and healthcare teams in hospital critical care settings to better control glucose levels with accurate, needle-free, continuous glucose readings. The skin permeation feature of Echo's current generation of Symphony CTGM System involves SonoPrep, Echo's FDA-cleared device using ultrasound-mediated skin poration technology. Echo Therapeutics is a platform-enabled specialty therapeutics and diagnostics company developing a broad pipeline of both advanced topical reformulations of FDA-approved products using its AzoneTS dermal penetration technology, and Symphony, a wireless, needle-free, CTGM system for the diabetes and hospital critical care markets.

• FlowCardia (Sunnyvale, California) reported FDA clearance and immediate U.S. launch of the Crosser 14P, Crosser 14S and Crosser 18 CTO Recanalization Catheters. The three peripheral Crosser catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross chronic total occlusions (CTOs) to help restore blood flow to the lower legs. The Crosser is a rapid-exchange catheter delivered over standard .014" and .018" guidewires that utilizes high-frequency vibration to cross CTOs, allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral Crosser catheters were studied in the FlowCardia PATRIOT Trial. PATRIOT principal investigator Jim Joye said, "After completing the clinical trial, we are looking forward to using the Crosser in our daily practice. The device worked well in the upper leg and also proved an excellent primary therapy for crossing the more difficult, below the knee occlusions. This new endovascular line of catheters will help us cross lesions that previously could only be treated with a more invasive open surgery."

• GE Healthcare (Waukesha, Wisconsin) said it now offers improved dose reduction results for both diagnostic cardiac and neuron perfusion CT exams. GE's SnapShot Pulse technology for prospectively gated diagnostic cardiac CT exams has been proven to reduce a patient's radiation exposure by up to 83% and improve image quality, according to GE. The company said its VolumeShuttle technology delivers twice the anatomical coverage (80 millimeters) with up to 24% less radiation exposure compared to a conventional 40 millimeter cine perfusion protocol. Both SnapShot and VolumeShuttle are offered on the GE LightSpeed VCT XT configuration, enabled by a real-time scan control architecture intended to ensure precise control of exposure and table position, the company noted. GE also introduced new editions of its Logiq e compact and a new edition of the Logiq Book XP Enhanced compact. According to the company, Logiq Book XP Enhanced is the third major upgrade of the Logiq Book platform. New features include: new LCD technology with higher resolution, improved off-angle viewing for multiple users, increased brightness and clarity. Faster processing on this new system improves boot-up time by 70%, the company noted. Other faster processing improvements include a 30% faster mode transition, such as changing from black-and-white imaging to color Doplar for vascular applications. GE offers a range of products and services designed to enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier.

• Immunicon (Huntingdon Valley, Pennsylvania) said that it filed with the FDA a request for clearance of the Cellsearch circulating tumor cell kit as an aid in the monitoring of patients with metastatic androgen-independent prostate cancer. Immunicon announced that it had successfully met the primary endpoint associated with its pivotal clinical trial in metastatic androgen-independent prostate cancer in January 2007. The primary endpoint required demonstrating that circulating tumor cells levels three-to-five weeks after the initiation of chemotherapy predict overall survival. Results showed that serial CTC measurement before and after initiation of therapy in men with androgen-independent prostate cancer delivered more reliable information about disease progression and patient survival months earlier than the traditional measurement of changes in prostate-specific antigen (PSA) measurements. Immunicon makes cell- and molecular-based human diagnostic and life science research products with an initial focus on cancer disease management.

• iWorx (Dover, New Hampshire) reported introduction of the GA-200 oxygen and carbon dioxide gas analyzer. The GA-200 uses laser diode absorption technology and infrared detection to measure 5 to 100% oxygen and carbon dioxide concentration over a 0 – 10% range in gases. A high sampling rate of 10 milliseconds (100 times per second) enables measurement of breath-to-breath samples from an exercising subject or gas from a mixing chamber. The GA-200 incorporates a fluorescent measurement display, a keypad for programming the unit's operation and calibration, and analog outputs that enable connection to data recorders such as the iWorx 214 Data Acquisition System. The compact analyzer measures 190 mm wide x 76 mm high x 280 mm deep and is factory calibrated and ready to run without further set-up requirements. iWorx makes advanced physiology teaching and life science research tools.

• Lifeline Biotechnologies (Reno, Nevada) said that the company's recent meeting with the managing engineer of Nanyang Technical University concerning the finalization of the First Warning System patient data interpretive software was encouraging. Additional cases of patient data were received, downloaded and reviewed by the development team at the university and the upgrading of the first warning system (FWS) can be accelerated. The new advancements could allow the FWS to classify women who have periodic breast examinations to identify normal, suspicious and positive ranges for breast cancer. The preliminary estimate is that an additional 300 patients will need to be tested and the company is determining the period of time required to complete this testing. Preliminary estimates by Lifeline's management suggest the possibility of completion in 2008. Lifeline Biotechnologies is focused on completing the development of the first warning system, which was designed to assist in the early detection of breast cancer.

• Medtronic (Minneapolis) reported FDA clearance of the Reveal DX and Reveal XT, new Insertable Cardiac Monitors (ICMs) that offer diagnostic and monitoring insights to cardiologists managing their patients with syncope (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole. The Reveal devices expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal and Reveal Plus Insertable Loop Recorders. The Reveal DX will be commercially available in the U.S. next week; the Reveal XT will follow. The Reveal DX continuously monitors the heart's electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques. Placed under the skin of the chest area using local anesthesia during a simple outpatient procedure, the Reveal DX monitor records important cardiac rhythm data, which may help a physician to diagnose the patient so the appropriate treatment can be undertaken. The device weighs 15 grams and is about the size of a memory stick. Unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads that extend from the device into the heart's chambers.

• Merge Healthcare (Milwaukee) reported the introduction of eFilm Workstation version 3.0, an enhanced version of Merge's desktop diagnostic imaging software. eFilm offers enhancements in both a gold version and a platinum version that are designed to accelerate radiologist productivity. With a range of tools, including window/level presets, synchronized stacking, MPR reference lines, cine function and integrated CD burning — in addition to other capabilities such as volume rendering and MPR creation — eFilm supports the daily workflow of any imaging environment. eFilm also can be used as a back-up viewer during disaster recovery if an existing PACS goes off-line. Merge Healthcare is a medical imaging software and services provider.

• Omnicell (Mountain View, California) introduced its SinglePointe total automated patient-specific management solution, which is the first in the industry. The SinglePointe solution provides an auto-assign process that matches patient-specific locations with patients and their medications that are not routinely stocked in the dispensing system. This feature significantly reduces the labor intensive process of loading and unloading medications in the dispensing system as well as the management of multi-use and "home" medications. Whether the patient is transferred or discharged, the SinglePointe solution's user intuitive workflow results in improved control and accountability of these patient-specific medications. Omnicell provides system solutions targeting patient safety and operational efficiency in healthcare facilities.

• Ortho Organizers (Carlsbad, California) said it has added a rectangular version to its super elastic nitanium black Ti archwire product line. The product offering has gained popularity with those practitioners within the orthodontic field placing self-ligating brackets due its ultra smooth, hard oxide surface which provides increased archwire integrity and improved resiliency, while reducing sliding friction. The black oxide treatment will not chip, wear or peel. Ortho Organizers makes orthodontic products.

• Patient Care Technology Systems (Mission Viejo, California), a subsidiary of Consulier Engineering, reported the general availability of the second generation of its software for tracking patients, staff and equipment. Amelior Tracker 2.0, an automatic tracking system, provides enhanced capabilities for identifying and locating resources within a new user interface. The software can be implemented for a department or throughout a facility. It is also available as an integrated module within the company's suite of workflow automation software where the real-time location of people and equipment works in combination with workflow intelligence to automatically track and orchestrate patient care status progression. The Amelior Tracker 2.0 software captures patient, staff and equipment location data by integrating with a real-time locating system comprised of wireless personnel and asset tags which communicate location information through a sensory network. Amelior Tracker 2.0 is compatible with all major locating technologies including ultrasound, infrared and radio frequency-based systems through a network of preferred locating hardware partners.

• Phase Forward (Waltham, Massachusetts) reported availability of version 2.6 of its Web Submission Data Manager (WebSDM) product. The WebSDM 2.6 software reads data from Phase Forward's InForm integrated trial management electronic data capture product, providing data managers with the ability to better understand the overall data quality of records under review. By enabling data managers to evaluate data more thoroughly at an earlier stage, the combined products can help to detect anomalies and trends to support safety analysis. The WebSDM product checks data for conformance with the clinical data interchange standards consortium study data tabulation model, creating a data repository that is then available for review and reporting purposes. Phase Forward makes data management solutions for clinical trials and drug safety.

• PLC Systems (Franklin, Massachusetts) reported that it has discussed the results of its pilot safety study of the RenalGuard system and therapy with the FDA. Based upon the positive safety data already collected in the pilot study and its discussions with FDA, PLC has stopped enrolling new patients in the pilot study and will submit a request to transition into a new pivotal trial protocol. The trial is expected to demonstrate that RenalGuard is effective in reducing the incidence of contrast-induced nephropathy (CIN) in at-risk patients undergoing cardiovascular imaging procedures. PLC Systems specializes in technologies for the cardiac and vascular markets.

• Reliant Technologies (Mountain View, California) reported that its Fraxel re:pair laser system has received FDA clearance for a fractional ablative treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The system, initially cleared for ablation, coagulation and skin resurfacin, becomes the only fractional ablative resurfacing system cleared by the FDA for specific indications of use. It is capable of being operated by a single clinician, because of its built-in smoke evacuation system, and capable of treating at depths from 300 micrometers ( m) to 1.6 mm into the dermis, all in a single hand piece. The laser delivers FMDA treatments for superficial photodamage, including pigmentation, fine lines, texture and vascular dyschromia. It also has the flexibility to deliver FDDA treatment for more severe rhytids and furrows by stimulating new collagen and elastin production deep into the dermis. Treatment is delivered with the safety and proven efficacy of a Fraxel brand treatment.

• Sangart (San Diego), a biopharmaceutical company focused on the development of oxygen transport agents, said an independent data safety monitoring board (DSMB) has recommended the continuation of both Phase III clinical trials of Sangart's lead blood substitute product, Hemospan, under current protocols. This recommendation follows the DSMB's review of the blinded data from the first one-third of the 830 patients to be enrolled in two ongoing Phase III pivotal studies in Europe. The DSMB will conduct another review after two- thirds of the patients have been enrolled. Hemospan is a hemoglobin-based oxygen transport agent designed to serve as an oxygen therapeutic and as an alternative to blood transfusions. Sangart says that a "key property of Hemospan is its high oxygen affinity which results in targeted oxygen delivery to tissues at risk of oxygen deprivation."

• Smith & Nephew's Endoscopy Division (Andover, Massachusetts) reported the launch of a redesigned and expanded family of Clear-Trac disposable cannulas, with a new, triple-seal system that reduces fluid leakage and helps surgeons manage sutures during arthroscopic surgery. The new seal system is specifically designed to minimize the leaking and spraying of surgical fluid from the cannula during procedures. Surgeons use sterile solution to distend the joint and create space to maneuver instruments during the repair process. The fluid within the joint is pressurized, to reduce bleeding and to flush away loose bodies or other materials. Smith & Nephew specializes in orthopedic reconstruction, orthopedic trauma and clinical therapies, endoscopy and wound management products.

• Smith & Nephew's Orthopaedic Reconstruction business (Memphis, Tennessee) reported the release of six-year clinical data related to its Birmingham hip resurfacing (BHR) system. The report was issued by the Australian Orthopaedic Association National Joint Replacement Registry. Data was tracked from September 1999 to December 2006 and revealed that the BHR device has the highest hip resurfacing system survivability rate among all of its established competitors for which data had been collected, highlighting the system's continuing clinical performance. Hip resurfacing is a bone-conserving alternative to traditional total hip replacement for patients suffering from abnormalities of the hip, including osteoarthritis. The BHR system conserves more of a patient's bone than a traditional hip replacement, enabling younger, more active patients to undergo hip replacement surgery while preserving all future surgery options, including a primary hip replacement.

The Sorin Group (Milan, Italy) reported the first commercial implant of the Mitroflow aortic pericardial heart valve in the U.S. Introduced in Europe in 1982, the Mitroflow valve is a testament to the company's experience with bovine pericardium, from tissue harvesting to proprietary design solutions and high technology processes. Because the pericardium is mounted on the outside of the stent, it allows for maximum valve opening and optimum blood flow. The Mitroflow bioprosthesis offers surgeons the option, based on patient anatomy, of a supra-annular or an intra-annular valve placement designed to reduce the risk of patient-prosthesis mismatch and enhance hemodynamic performance. The sewing cuff design has shown that the valve is easy to suture, conformable to the native annulus and adaptable to difficult anatomies.

• SPO Medical (New York) reported the introduction of the new PulseOx 6000 and PulseOx 6100. The PulseOx 6000 (finger device) and PulseOx 6100 (hand-held device) have both been designed for use by medical professionals, hospitals and managed care facilities. Both the devices use reflective pulse oximetry (RPO) technology for accurate and reliable measurements of blood oxygen saturation and heart rate, and include the SPO Medical new AutoSpot technology for patients suffering low perfusion. SPO Medical makes biosensor and microprocessor technologies for use in portable monitoring devices.

• Synthetic Blood International (Costa Mesa, California) said it plans to finalize a Phase IIb clinical trial protocol with Oxycyte for the treatment of traumatic brain injury (TBI) at its scientific advisory board meeting. Oxycyte is Synthetic Blood's perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute. The proposed double blind, placebo-controlled Phase IIb trial is designed to compare Oxycyte with present-day advanced therapies in TBI, and is expected to enroll 120 to 150 patients at six major neurosurgery centers. The company's board said it plans to develop a strategy for initiating supportive preclinical studies to explore the basic science of Oxycyte's oxygen delivery capabilities for the treatment of damaged brain tissue, and the effects of higher Oxycyte doses than have been used in previous studies, as well as the potential effects of administering second doses of Oxycyte.

• Talyst (Bellevue, Washington) unveiled the latest generation of automation systems for central-pharmacy operations, designed to meet the evolving needs of acute-care hospitals, medical centers and integrated healthcare systems. AutoPharm 3, Talyst's software platform, links and unifies disparate systems of various manufacturers, all to enable the central pharmacy to achieve enhanced patient safety, improved operating efficiency and precise pharmacy control. Throughout the hospital, medications can be tracked from the point of entry to the automated dispensing unit or patient care area. New features of the AutoPhram 3 include: broader inventory control, chain of custody, mobile computing, and productivity reporting. Talyst provides automated systems to hospitals and other centralized pharmacies.

• Vapotherm (Stevensville, Maryland) introduced a new respiratory care device. The company said its Precision Flow is the first high-flow therapy device to integrate humidification, gas blending, flow control and full alarm functionality into a single device for the delivery of nasal cannula inspired gases. With Precision Flow, the respiratory community will have a new option in high flow therapy that includes broader functionality, additional safety features and ease of use. "We developed Precision Flow with extensive input from our respiratory customers and we believe the device will meet their stated requirements for performance, safety and cost-effectiveness," said Kevin Thibodeau, vice president of sales and marketing. Vapotherm makes high flow oxygen therapy products.

• Vidacare (San Antonio) reported receiving FDA approval for its bone-marrow biopsy system for hematology/oncology. The new technology is designed to increase control, improve core capture rates and reduce patient discomfort during bone-marrow biopsy procedures. Vidacare will market the lithium-battery powered device under the OnControl Bone Marrow Biopsy System brand. "The FDA's approval of the OnControl Biopsy System is a key milestone for Vidacare as well as patients requiring bone marrow biopsies," said Philip Faris Jr., CEO of Vidacare. Bone marrow biopsies are necessary for the diagnosis and management of lymphoma, leukemia, myeloma and other hematological disorders. Vidacare is a developer, manufacturer and marketer of advanced intraosseous (through-the-bone) access medical technology.

• Ymed (San Diego) said it has completed its first U.S. cases with its VascuTrak II PTA dilation catheter. The catheter is a 5 Fr compatible, single-operator, rapid exchange system, Ymed said. It is designed and indicated for vascular intervention of a wide range of peripheral arteries, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Ymed makes products for vascular intervention, providing less-invasive therapy for a range of circulatory diseases.