BB&T Staff Writer and Staff Reports

A new study seeks to prove that early intervention with W. L. Gore & Associates' (Flagstaff, Arizona) Viatorr Transjugular Intrahepatic Portosystemic Shunt (TIPS) endoprothesis device improves transplant-free survival when compared to large volume paracentesis in patients with cirrhosis and difficult to treat ascites.

The study is expected to be the largest and most rigorous multi-disciplinary collaboration with hepatologists and interventional radiologists looking at early TIPS therapy. “What we intend to prove — to really see, is if people live longer with early TIPS intervention without needing a transplant,“ lead co-investigator Ziv Haskal, MD, told Biomedical Business & Technology.

TIPS therapy is a minimally invasive procedure done with closed surgery, as only a small puncture is made in the jugular vein for insertion of the TIPS device. A TIPS creates a new channel to route blood flow through the damaged liver and into the main blood vessels that lead blood back to the heart.

With the TIPS procedure, alternative treatments such as medications and paracentesis for ascites, and the treatment of varices may not be needed as often.

The study seeks to look at more than 300 patients in sites throughout North America, according to Haskal.

In the past, TIPS therapy studies are believed to have failed to demonstrate increasing life expectancy for patients because only end stage patients were included. These previous trials with bare metal stents (BMS) showed TIPS was a bridge to transplant at best.

By including patients in earlier stages of the disease investigators hope to show there is an improvement in lifespan. Investigators went on to say that by capturing patients a little earlier they might be able to impact a patient's quality of life, as TIPS therapy may improve the ascites and slow the disease progression.

Gore said the device is the only covered stent that is indicated for TIPS creation and revision. The device is a flexible, self-expanding, implantable endoprosthesis with a proprietary, reduced permeability expanded polytetrafluoroethylene (ePTFE) graft lining. Featuring improved radial compression strength over other commercial stent configurations, it is designed to provide secure anchoring with minimal kinking.

Trial data shows that the device has changed the landscape in TIPS procedures and optimized primary patency rates in the process. According to Haskal, fundamental and significant improvements in TIPS therapy are seen when using a covered stent vs. a BMS.

“Unlike a bare metal stent, the Gore Viatorr TIPS Endoprosthesis improves patency to such a degree that nearly all repeated invasive procedures on TIPS patients have disappeared,“ Haskal said. “New data concerning covered stents forced us to take a fresh look at all earlier randomized studies comparing bare metal TIPS to other treatments. The possibility that we may prolong patient lives is one of the most exciting new questions in TIPS therapy that we must answer.“

He added that Gore's stent which received FDA approval back in December of 2004, changed the way radiologists look at TIPS procedures.

“In the previous decade I have done more than 500 procedures to open up blocked TIPS stents,“ Haskal said. With the introduction of Gore's Viatorr Tips, the need to do those procedures has gone away entirely.“

The Gore study for ascites patients comes on the heels of a landmark study published in The New England Journal of Medicine comparing early TIPS intervention with the device to pharmacotherapy/endoscopic band ligation in high risk variceal bleeding patients with positive results.

This study provided sufficient fuel for Gore's study, and could pave the way for a real medical breakthrough when it comes down to treating patients with TIPS procedures.

“What happens if we prove our primary hypothesis? I think there are a very large number of patients that we could potentially offer this therapy to,“ Haskal told BB&T. “This really could be a game changer.“

Elsewhere in the product pipeline:

• Accuray (Sunnyvale, California) reported studies at two academic institutions using CyberKnife radiosurgery in breast cancer treatment. Because of the non-invasive delivery and high precision that the CyberKnife system offers in treating tumors throughout the body, clinicians see a role for it in breast cancer treatment. The CyberKnife system has the ability to not only track tumor movement during respiration, but to also lock onto the tumor as it moves delivering radiation directly to the tumor and avoiding damage to surrounding critical structures. The CyberKnife system's extreme precision enables clinicians to reduce the treatment margins that are often added with conventional IMRT systems. For this reason, clinicians believe partial breast irradiation using the CyberKnife system holds the potential to improve toxicity and associated side effects for patients, the company said. The CyberKnife robotic radiosurgery system is designed to treat tumors anywhere in the body non-invasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife system automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment.

• Arstasis (Redwood City, California) reported patient enrollment has begun in the RECITAL (A Patient Registry Evaluating Closure Following Access with the Arstasis One Access System) Study. The goal of the study is to observe the clinical safety and effectiveness of the Arstasis One Access System in patients undergoing diagnostic angiography procedures through the femoral artery. Since 1959, physicians have been using the Modified Seldinger Technique to insert flexible catheters into the femoral artery of patients for the purpose of performing procedures in the patient's arterial-vascular system. The most prevalent such procedure, angiography, is thought to be performed more than half a million times per month worldwide. At the end of every such case, each patient is left with a substantial hole in his/her femoral artery (upper inner thigh) which typically takes significant effort and cath lab resources to get to stop bleeding. With the Arstasis One Access System, however, physicians may create a shallow-angle needle pathway through the wall of the femoral artery. At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the normal pressure of the patient's femoral artery blood flow from below and about 3-4 minutes of mild, non-occlusive finger-pressure from above, resulting in a quickly sealing access site. The Arstasis One is used in the Arstaotomy procedure, a new way to gain access to the femoral artery that improves upon the Seldinger Technique and that some physicians believe results in a more pleasant and efficient cath lab and post-procedure experience for clinician and patient alike.

• ArthroCare (Austin, Texas) has received FDA clearance for its Spartan PEEK Suture Implant system. Spartan is a preloaded PEEK threaded anchor indicated for use in fixation of soft tissue to bone, such as during a rotator cuff repair. Spartan has a 5.5 mm, screw-in design which provides stronger pull-out strength, particularly in soft bone and can be used to perform single and double row repairs. Spartan is manufactured from PEEK, (polyether-etherketone) a material widely used in orthopedic implants, and will be used to reattach rotator cuff tendons to bone. ArthroCare makes minimally invasive surgical products.

• Atritech (Minneapolis) reported initial enrollment into its confirmatory study, PREVAIL, comparing the Watchman Left Atrial Appendage Closure Device to long-term warfarin therapy in patients with atrial fibrillation. The Watchman Device is designed to keep harmful sized blood clots from entering a patient's blood stream, potentially causing a stroke. Patients with atrial fibrillation (a heart condition which causes the upper chambers of the heart to beat too rapidly) are at a greater risk of having a stroke due to the formation of clots in an area of the heart called the left atrial appendage (LAA). Typically these patients require blood thinning medications such as warfarin to prevent these clots from forming in the heart. The WATCHMAN Device may be a viable alternative for patients with atrial fibrillation who may not want to take blood thinning medications for life.

• AutoGenomics (Vista, California) has received FDA clearance to market its Infiniti CYP2C19 Assay. The test detects 3 genetic variants, *2, *3, *17, of the CYP450 2C19 gene and is to be used on the company's automated molecular testing platform, the Infiniti Analyzer. “We are very excited to receive FDA clearance for our 2C19 test“ said Fareed Kureshy, president/CEO of AutoGenomics. “The necessity of this genetic test has been implicated in literature now for several years. The FDA has now provided clinicians with a tool in determining medical strategies for therapeutics that are metabolized by the CYP 450 2C19 gene test specifically * 2, *3, *17. This is an important milestone in the era of personalized medicine. Several of our customers are awaiting such clearance to implement testing in their practice.“ AutoGenomics makes automated, microarray based multiplexing diagnostic platforms.

• Biomoda (Albuquerque, New Mexico) reported findings from a study showing the potential of the company's non-invasive CyPath assay for the detection of early-stage lung cancer. Biomoda says its CyPath screening protocol is simple. The company collects deep-lung sputum from patients, processes the sample onto a microscope slide, and incubates the slide in the CyPath labeling solution. During the incubation period, CyPath binds to cancer cells, which, if present, will fluoresce when viewed under a microscope using specific frequencies of medium light.

• Bovie Medical (Melville, New York) has applied for 510(k) clearance from the FDA to market its J-Plasma handpiece with retractable cutting features in both laparoscopic and open configurations. The newly developed devices will offer soft tissue coagulation and/or tissue cutting with and without simultaneously applied J-Plasma energy. With its extended knife and no conventional RF or J-Plasma energy applied, the devices would be similar to a conventional scalpel, suitable for a tissue biopsy. However, by combining J-Plasma energy with the extendable knife, the devices offer an enhanced cutting and coagulation capability. The multi-modal devices will allow Bovie to support soft tissue coagulation and cutting in gynecology, general, urology, neurology, vascular, plastics and cardio-thoracic surgery.

• Carestream Health (Rochester, New York) received FDA approval for its high-resolution computed radiography (CR) system for mammography. Once the FDA approves the final product labeling, Carestream Health can begin commercial distribution of this innovative CR system for mammography in the U.S. The company's Carestream Directview CR Mammography Feature enables mammography images to be captured digitally while using a healthcare provider's existing mammography x-ray unit and workflow processes. It is intended for use in the same clinical applications as traditional screen-film based mammography systems. With this feature, Carestream Health's CR systems can be used for both general radiography and mammography exams.

• A study performed by investigators from the Emergency Department of the Cleveland Clinic Foundation finds that Cheetah Medical's (Tel Aviv, Israel) NICOM system is effective in identification of acute heart failure (AHF) and in differentiating it from other acute situations with similar clinical presentations. The study was published last week in the American Journal of Emergency Medicine. In this study, the NICOM Noninvasive Cardiac Output & Hemodynamic Monitoring System was able to distinguish heart failure patients from patients diagnosed with COPD, asthma and dyspnea for other reasons. This non-invasive bedside test uses a set of four sensors applied on the patient's chest or back. In this study, the system was used to monitor patients' hemodynamics around a change in patient position, also known as “orthostatic challenge.“

• Competitive Technologies (Fairfield, Connecticut) said researchers at Virginia Commonwealth University Massey Cancer Center have begun accepting patients into a new Phase II clinical study to evaluate the efficacy of the innovative Calmare Pain Therapy medical device for the treatment of cancer pain syndromes. In addition to addressing chronic chemotherapy-induced peripheral neuropathy (CIPN) pain and numbness, this trial will also test the Calmare medical device's ability to treat post mastectomy pain, post surgical pain, post herpetic neuropathy, post radiation pain and other chronic pain. Competitive Technologies's principal technology is the non-invasive Calmare pain therapy device, which uses the biophysical “Scrambler Therapy“ technology.

• New research published in The Journal of Clinical Embryology shows Cook Medical's (Bloomington, Indiana) MINC Benchtop Incubator and embryo culture sequential media system to more reliably maintain in vitro fertilization (IVF) culture conditions than traditional incubators, resulting in superior IVF culture results. The peer-reviewed study first compared the MINC to a standard laboratory incubator, examining the internal environment of both devices when the incubator doors are opened and the embryos inside are exposed to potentially damaging outside elements. The study compared the CO2 levels, pH and temperature when the doors of the incubators were opened for certain lengths of time to determine which incubator returned to optimal environments most efficiently. The study results showed Cook's MINC taking just 12 minutes to recover 90% of the measured parameters, and the typical laboratory incubator taking 180 minutes. Fertilization rates were also superior when the MINC was used, showing clinical pregnancy rates that were 10% higher than the Forma 3110. Because preserving precise temperatures and pH is essential for optimal embryo development, quick recovery rates lessen the disturbing effect that opening the incubator door can have on the embryos inside.

• Covidien (Mansfield, Massachusetts) reported FDA clearance for the Kendall SCD Sequential Compression Comfort Sleeve and Kendall SCD 700 Series Controller. The company's new system will be launched next month in the U.S. and will deliver an improved level of comfort for patients, while reducing the risk of venous thromboembolism (VTE). The system uses the clinically proven Kendall SCD technology, which delivers sequential, gradient, circumferential compression to reduce the incidence of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) without the bleeding risk associated with anticoagulant prophylaxis. With its DCS Technology, the Comfort Sleeve addresses the factors contributing to patient discomfort, including sweat, heat, itchiness, pressure and skin irritation. The all-in-one controller improves functionality and convenience with a new graphical user interface with animated icons, allowing for a more intuitive operation.

• DEKA Medical (San Francisco) reported the availability of the Excilite-u in the U.S. for the treatment of Leukoderma, Psoriasis, and Vitiligo. The Excilite-u uses a high-intensity Monochromatic Excimer Light of 308 nm to stimulate melanocytes in affected areas and restore color to the skin. The system is cleared for use on all parts of the body including hard to treat areas such as hands, elbows and knees. “We are excited to bring this world-class technology to the U.S. and offer hope to the many patients seeking solutions to post-resurfacing hypopigmentation,“ said Dale Koop, CEO of DEKA Medical.

• HoverTech International (Bethlehem, Pennsylvania) reported the introduction of their new Model HTAIR 1200 Air Supply to be used in conjunction with the HoverMatt Air Transfer System for safe patient handling. The HoverMatt Air Transfer System has been used extensively to assist caregivers in the lateral transfer and repositioning of patients anywhere in the hospital. When used, this system has been proven to dramatically reduce back injuries to staff caused by lateral patient transfers. After the patient is placed on the HoverMatt transfer mattress, low pressure air from the air supply is used to inflate the mattress and, at the same time, escape from small holes on the underside of the transfer mattress. The escaping air acts as a lubricant to reduce friction which facilitates effortless transfers. The HoverMatt Air Transfer System is available in multiple styles and sizes to accommodate any patient weight, and is ideally suited for the transfer of bariatric patients.

• NxStage Medical (Lawrence, Massachusetts) said that it has expanded its Medisystems in-center product portfolio to include Vasc-Alert's automated vascular access surveillance product. Vasc-Alert uses computer technology to analyze standard treatment data taken during each patient's scheduled hemodialysis treatments to screen for vascular access dysfunction. By monitoring the data for increasing pressure trends, Vasc-Alert identifies patients who are at risk of developing a stenosis that may decrease the effectiveness of treatment or put the access site at risk of thrombosis – a blockage that prevents the flow of blood through the access and can precipitate significant medical interventions such as thrombectomy and access revision. Weekly reports that identify at-risk patients are issued to the dialysis provider and allow the dialysis staff to proactively schedule further testing on the access. Earlier detection of access issues has the potential to lead to improved access patency, fewer hospitalizations, fewer missed treatments, and less pain, anxiety and inconvenience for patients. Vasc-Alert provides proactive surveillance of hemodialysis patients' access sites by analyzing the hemodialysis machine blood flow and pressure data to derive the intra-access pressures. If the patient's access site is determined to be at risk, an alert report is issued.

• PerkinElmer (Waltham, Massachusetts) reported the launch of its Delfia Xpress PlGF assay. The new assay is the first placental growth factor assay kit designed to help clinicians screen pregnant women for early-onset pre-eclampsia during their first trimester of pregnancy. Early-onset pre-eclampsia is a pregnancy complication that causes hypertension and associated physical symptoms and organ damage to expectant mothers, with adverse effects to unborn and newborn babies. Early-onset pre-eclampsia may cause delivery before 34 weeks and has been historically difficult to predict. The assay is designed for use with PerkinElmer's Delfia Xpress table-top clinical instrument, which is widely used for multiple prenatal screening tests.

• Roche Diagnostics (Indianapolis) reported the U.S. introduction of the cobas e 602 analyzer, the latest addition to the cobas 8000 modular analyzer series for diagnostic labs with high-volume workloads. The cobas e 602 module uses Roche's electrochemiluminescence (ECL) technology and includes more than 50 assays on its initial test menu. The cobas 8000 series is designed to meet the needs of high-volume laboratories to deliver high quality results fast and efficiently from a single patient sample. The series uses the same operator interface and the standardized reagent cassette concept used on other cobas analyzer platforms.

• Xstrahl (Camberley, UK), a maker of a range of superficial and orthovoltage radiotherapy systems, reported the launch of Imperium, a new control system for its X-ray therapy system. Imperium provides users of Xstrahl's radiotherapy systems with a clinical interface, and helping healthcare professionals to streamline the administrative aspects of patient care. The new controller can integrate with both time and dose systems, ensuring patients receive the prescribed dose, and its ability to integrate with electronic medical records can reduce the time needed for administrative tasks such as manually updating patient records. In addition, Imperium can prepare the machine for treatment using pre-programmed treatment regimes, saving valuable clinic time and facilitating enhanced patient care.