SmartPill (Buffalo, New York), developer of the SmartPill pH.p Capsule, a non-invasive medical device that captures biomedical data from within a patient’s gastrointestinal (GI) tract, reported this week that the clinical trial of its SmartPill pH.p Capsule and GI Monitoring System, has been completed successfully.

The SmartPill product, which measures GI tract pressure, transit time and pH through sensors on the ingestible pill, was studied for the diagnosis of gastroparesis, which is a motility disorder in which food does not pass out of the stomach and through the system normally. The trial was launched in March.

“We’re very excited about the results of the clinical trial,” SmartPill President and CEO David Barthel told The BBI Newsletter, noting that the SmartPill pH.p Capsule is “actually the first device of its kind that allows you to measure the entire GI tract.”

Barthel said of the trial, “First of all, it’s a significant milestone for the company.” He said it was the “largest gastric emptying trial ever conducted in the U.S. We ran 78 healthy and 57 gastroparetic [subjects].” He added: “That in itself is an accomplishment, [because] it’s not easy to do. And thirdly, the data is stronger than we had anticipated ...there’s a strong correlation for our intended use.”

The primary objective of the study was to demonstrate the correlation of gastric residence times measured by the SmartPill pH.p Capsule and gastric emptying scintigraphy, the company said.

Scintigraphy is the current method of diagnosing gastroparesis, a method that is “very invasive, very uncomfortable,” he said.

The study involved seven of the leading motility centers in the U.S., the company said, including Massachusetts General Hospital (Boston), Temple University Hospital (Philadelphia), Wake Forest University Baptist Medical Center (Winston-Salem, North Carolina), the University at Buffalo, the University of Louisville, the University of Kansas Medical Center (Kansas City, Kansas) and the University of Michigan Health System (Ann Arbor, Michigan).

Elsewhere in the product pipeline:

Aastrom Biosciences (Ann Arbor, Michigan) said that the first clinical trial using Aastrom’s Tissue Repair Cells (TRCs) to treat limb ischemia in diabetic patients has been initiated at the Diabetes Center at the Heart and Diabetes Center North Rhine-Westphalia (Bad Oeynhausen, Germany). Initiation of the trial followed the center’s receipt of the licenses and the investigational medicinal product dossier necessary to manufacture and use cells for clinical trials in compliance with the new European Union directives. The aim of the study is to evaluate the safety and ability of Aastrom’s bone marrow-derived TRCs to regenerate functioning blood vessels in the legs of diabetic patients with limb ischemia. The company said it expects that the first phase of the trial will be completed in about 12 months.

• Abiomed (Danvers, Massachusetts), a manufacturer of medical products designed to assist or replace the pumping function of the failing heart, reported data presented at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics scientific symposium in Washington on its Impella Recover LP 2.5, a minimally invasive percutaneous ventricular unloading catheter. The single-center experience at the Academic Medical Center (Amsterdam, the Netherlands) of 21 patients has found that using the Impella as a left ventricular assist device during high-risk angioplasty/stenting procedures is both safe and feasible, providing hemodynamic support and improving coronary circulation, without compromising coronary blood flow. The results were described in two presentations: one that confirmed the safety and feasibility of using the Impella Recover LP 2.5 as a left ventricular support in patients undergoing high-risk angioplasty/stenting procedures; and another that showed that the CE-marked Impella Recover not only unloads the heart but that can also increase coronary perfusion needed to provide oxygen to the heart itself, in a study of 11 patients undergoing high-risk angioplasties.

• Acuity Medical (Brighton, Michigan) said it is working with the FDA to design the pivotal premarket approval clinical trial for TheraMac, a treatment of dry age-related macular degeneration (AMD). There is no approved treatment for dry AMD at present. The proposed trial will have a three-month efficacy endpoint and a six-month safety endpoint and will include about 300 patients. Acuity Medical has already successfully completed a proof-of-concept FDA trial of TheraMac which showed that in two weeks 26% of the eyes treated had improved vision by 10 letters or more, the equivalent of two lines on the eye chart (Medical Device Daily, Oct. 17, 2005). TheraMac produces minute amounts of electrical biocurrent that is delivered to the retina through a probe that touches the skin around the eye. The biocurrent facilitates increases in membrane permeability, improves cellular functionality and stimulates cellular repair.

• Animas (West Chester, Pennsylvania), a maker of insulin infusion pumps and related products for the management of diabetes, said it has launched the ezSet Infusion Set. The set features a tan-color tape to provide greater user discretion, as well as the traditional white tape; a trocar-style introducer needle designed for ease of insertion; color-coded components for ease of use; and a large viewing window for site visibility. The set also includes a tapered cannula, smooth edges and a low profile infusor base. The tape, made of specially woven cotton material with longer tabs, adds to the set’s greater comfort and wearability, Animas said.

• The CombiMatrix Group (Mukilteo, Washington) of Acacia Research (Newport Beach, California) said it has launched a new comprehensive influenza DNA microarray as well as services for the typing of influenza strains. CombiMatrix’s Influenza Microarray is now a member of the CatalogArray product line and can detect and accurately type flu strains using a protocol that requires less than four hours start to finish. The microarray can identify H5N1 bird flu as well as all other strains of Influenza A. It is designed to work on samples from humans as well as animals. The Influenza Microarray provides high-resolution genotype information on any given flu strain as well as information on novel strains of flu produced by rapid mutation or recombination between multiple strains of flu. This system is available to the flu researcher as a tool or as a service from CombiMatrix. This system also is being developed as a field-deployable biodetector using electrochemical techniques for analysis.

• CryoLife (Atlanta), a biomaterials and biosurgical device company, reported that its BioDisc Spinal Disc Repair System, a nucleus pulposus repair device, has been successfully implanted in four patients. The implants are part of a 10-patient feasibility study in the UK designed to gather basic safety and performance data. The study is targeted to address spinal disc herniations at the L4/L5 and L5/S1 levels. The company said the early clinical course of these patients is proceeding as expected.

• EDAP TMS (Lyon, France) presented clinical data on the success of high-intensity focused ultrasound (HIFU) with its Ablatherm device at the 5th International Symposium on Therapeutic Ultrasound (ISTU) held at Harvard Medical School (Boston). Several summaries and papers related to its treatment success and clinical advances related to the field of localized prostate cancer were presented during the ISTU gathering. Stefan Thuroff, MD, of Harlaching Hospital (Munich, Germany), presented a follow- up study of more than 1,000 patients treated with Ablatherm. The results showed a success rate up to 93.7% based on negative biopsies and a Nadir PSA down to 0 for low- and intermediate-risk patients. In a different presentation detailing the side effects related to HIFU with a follow-up at eight years and a population of 1,200 patients Professor C. Chaussy, also of Munich, demonstrated Ablatherm HIFU proved to have low occurrences of short and medium range side effects. Albert Gelet, MD, of Edouard Herriot Hospital (Lyon, France), reported a cancer-free rate of 84% in 124 Ablatherm-treated patients at seven years without additional therapy.

• Endologix (Irvine, California) reported that the first patients have been treated in the company’s infrarenal clinical trial using a 34 mm diameter cuff with the Powerlink Bifurcated System. The three minimally invasive surgical procedures were performed at Lexington Medical Center (West Columbia, South Carolina) as part of the seven-center, 60-patient trial. The Powerlink System is a bifurcated endoluminal stent graft approved by the FDA for the minimally invasive treatment of abdominal aortic aneurysm (AAA). Endologix also is conducting an ongoing suprarenal clinical trial using the Powerlink 34 mm Bifurcated System, a modification of Endologix’s FDA-approved Powerlink System, which is an alternative or potentially complementary technology to treat AAA patients with large-diameter aortic necks.

• Fujinon’s Medical Division (Wayne, New Jersey), a developer of advanced endoscopic systems, reported the launch of the first commercially available fully digital endoscope system with both Fuji Intelligent Chromo Endoscopy (FICE) and high-resolution imaging. The fully digital endoscope system, commercially referred to as EPX-4400, is being presented during this week’s American College of Gastroenterology meeting in Honolulu, Hawaii. The company said the EPX-4400 system is the only commercially available fully digital endoscope system. Fujinon described FICE as “a revolutionary technology developed to mimic chromo-endoscopy without the use of messy, time-consuming and irreversible tissue-staining dyes.” The company said FICE creates a similar effect electronically, enabling a physician to visually enhance suspect structures not visible under normal endoscopic conditions. When used in conjunction with the Fujinon 450 Series endoscopes, the 4400 system provides nearly twice the resolution of comparable systems, Fujinon said. It added that the 490 Zoom Series endoscopes with Super CCD technology can resolve images three times finer, meaning it can resolve detail the size of a human red blood cell. Fujinon said, for example, that FICE could assist a physician with taking targeted biopsies of suspect areas vs. random biopsies.

• GE Healthcare (Waukesha, Wisconsin) said it introduced ViewPoint 5.0, the industry’s most comprehensive ob/gyn data management solution for quicker, easier ultrasound workflow, at the World Congress on Ultrasound in Obstetrics and Gynecology in Vancouver, British Columbia. ViewPoint 5.0 combines reporting and image archiving capabilities with a new database technology that speeds report creation while capturing data for statistical analysis. An integrated DICOM work list simplifies the patient exam, while one-click data transfer for measurements and images from the ultrasound scanner saves clinicians time and ensures accuracy. Streamlined system interfaces provide connectivity to the EMR or HIS/RIS, giving clinicians a window to all their patient data at any ViewPoint 5.0 workstation.

• Given Imaging (Yokneam, Israel) said that 16 independent studies of its PillCam SB were presented at the recent 13th United European Gastroenterology Week in Copenhagen, Denmark, including one that confirmed data from past studies recommending use of PillCam SB as a first line diagnostic tool in patients with suspected small-bowel Crohn’s disease (CD). Dr. Ervin Toth of Malmo University Hospital and Lund University Department of Medicine (Malmo, Sweden) presented a single-center, prospective and partly blinded study comparing the diagnostic value of PillCam SB to traditional methods of evaluating small-bowel CD in 65 patients with clinically-suspected active CD. “PillCam SB should be the method of choice in patients with suspected, non-stricturing small-bowel Crohn’s disease,” Toth said. “[It] SB is not only a more accurate imaging modality for visualizing Crohn’s lesions in the small bowel, but it was also preferred by almost all patients in our study.” Additional studies reported at the meeting examined PillCam SB’s role in influencing clinical outcomes in patients with unexplained bleeding and suspected CD.

• iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions, reported the availability of PowerLook, a software extension to its SecondLook Viewer product line. SecondLook Viewers are used in conjunction with the company’s SecondLook 300 and SecondLook 700 CAD solutions. The SecondLook Viewer displays a digital rendering of the mammogram, including CAD marks to highlight suspicious areas on a mammogram, on a high-resolution, touch-screen monitor. The iCAD system and the new PowerLook viewer are designed and provided to support a radiologist doing primary reading of mammograms and related diagnosis from the original mammography films. The company said PowerLook features such as digital zoom, rules, and window/level adjustments are easier to use than the traditional magnifying glass, clear plastic ruler and bright light. When offered for use with film-based CAD, physicians can use the new PowerLook features to further examine the information in the image before making the final read based on the film.

• Inovio Biomedical (San Diego), a late-stage developer of therapies using electroporation to deliver drugs and nucleic acids, reported that it has initiated a Phase I clinical trial to treat locally recurrent cancer after a mastectomy or partial mastectomy using its Selective Electrochemical Tumor Ablation (SECTA) therapy. The study is designed to demonstrate that SECTA therapy, which provides selectivity in killing cancerous cells, can preserve surrounding healthy tissue when treating solid tumors while providing equivalency to surgery in terms of local tumor control. As an alternative to mastectomy for managing recurrences after prior breast conserving therapy, SECTA could potentially provide important quality of life benefits to breast cancer patients. The multi-center, open-label, single treatment arm trial may enroll up to 24 patients with locally recurrent or metastatic in-breast carcinoma after partial mastectomy or cutaneous or sub-cutaneous recurrent or metastatic carcinoma of the breast or chest wall following mastectomy. The primary endpoint is to assess the safety profile of Inovio’s electroporation-based SECTA therapy in conjunction with intralesionally-injected bleomycin.

• Laserscope (San Jose, California), a pioneer of minimally-invasive medical lasers and advanced fiber-optic delivery devices, reported the results of a milestone study evaluating the long-term outcomes of men treated with photoselective vaporization of the prostate (PVP) for benign prostatic hyperplasia (BPH) using its GreenLight laser system. The study, conducted at the Mayo Clinic (Rochester, Minnesota), was published in the October issue of the Journal of Urology. The study evaluated 94 patients suffering from obstructive BPH who were treated with PVP using Laserscope’s GreenLight laser system and disposable fiber optic delivery devices. “The results of our study demonstrate significant and sustainable improvements in the outcomes of patients suffering from obstructive BPH,” said Dr. Reza Malek, lead author of the study and professor emeritus of urology at the Mayo Clinic. “Given that PVP has a well-established record for safety, low morbidity and rapid recovery, we are very pleased to reinforce its contribution as an effective, long-term treatment solution for many men suffering from obstructive BPH.” Laserscope also reported that in conjunction with the publication of the study, it has partnered with the Men’s Health Network (Washington) to launch a national campaign called Heal BPH to provide men with the resources they need to better understand BPH, prostate health, sexual health and other related health issues.

• Lumenis (Yokneam, Israel), a manufacturer of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, said that it has received FDA clearance to market the new Aluma Skin Renewal System with FACES (Functional Aspiration Controlled Electrothermal Stimulation) technology in the U.S. The company said the Aluma system is the world’s first system to offer effective, predictable and virtually painless non-invasive treatment of fine lines and wrinkles. Aluma’s FACES technology combines radio frequency (RF) energy with vacuum to allow superficial as well as deep dermal heating for effective treatment, with virtually no pain and very low risk of adverse events. The vacuum-assisted bipolar RF handpiece folds the skin and positions it in tight contact with the electrodes, placing the dermis in direct alignment with the energy. Special alignment of the electrodes enables RF energy to meet dermis impedance, which results in a uniform, contained zone of heating for collagen contraction and renewal with little to no discomfort.

• Nanogen (San Diego), developer of advanced diagnostic products, reported it was issued U.S. patent No. 6,942,778, “Microstructure Apparatus and Method for Separating Differently Charged Molecules Using an Applied Electric Field” by the U.S. Patent and Trademark Office. The patent relates to a biological screening device used to monitor the activity of kinase, protease or phosphatase enzymes on peptide substrates. The technology described in Nanogen’s patent also allows for simpler, faster and safer molecular analyses using fluorescent labeling. In addition, Nanogen reported that its Epoch Biosciences (Bothell, Washington) subsidiary was issued U.S. patent No. 6,951,930, “Hybridization-Triggered Fluorescent Detection of Nucleic Acids.” Epoch’s patent relates to latent fluorophore-minor groove binder oligonucleotide conjugates which fluoresce upon hybridization to a target. The conjugates may be used to detect nucleic acid targets. The technology described in the patent also allows for simpler and faster fluorescent real-time molecular analyses.

• Medtronic Sofamor Danek (Memphis, Tennessee) reported the U.S. market availability of its METRx II Set that may be used in surgery to simplify disc removal and pave the way for minimally invasive spine fusion. The METRx II Set incorporates coated, bevel-tipped retractors, which reduce light source reflections and minimize soft tissue damage. The increased visualization allows surgeons to perform minimally invasive surgical techniques using tubular retractors under microscopic conditions. A color-coded system has been incorporated into the newly designed surgical instrumentation, including ergonomic silicon handles, ejector style kerrisons, stronger micropituitaries and double-ended penfields. The product was launched at the Congress of Neurological Surgeons meeting in Boston.

• Retractable Technologies (Little Elm, Texas), a maker of safety needle devices, reported it has received FDA 510(k) approval to market the VanishPoint automated retraction intravenous (IV) catheter. The device is expected to be available in a variety of sizes by the end of December. The VanishPoint IV catheter uses automated retraction technology and is designed to allow clinicians to introduce the catheter into a vein or artery using a technique similar to what they would use with a conventional catheter. Before removing the introducer needle, the clinician activates the safety mechanism, which automatically retracts the needle into the handle of the introducer, substantially reducing the risk of a needlestick injury.

• Sigma-Aldrich (St. Louis), a manufacturer of biochemical and organic chemical products, reported the launch of Panorama Human Cancer Version 1 Protein Functional Microarray. Developed by Procognia (Berkshire, UK) and licensed exclusively to Sigma-Aldrich, the Cancer V1 protein microarray contains 130 correctly folded proteins. These proteins are selected from a recent seminal scientific publication that reviewed and compiled all proteins that are implicated in mediating cancer.

• St. Jude Medical (St. Paul, Minnesota) reported the U.S. launch of an advanced catheter for placing guidewires during catheterization procedures. The Venture Wire Control Catheter was designed to give cardiologists more control and support as they steer guidewires during interventional cardiology procedures. The Venture catheter features a deflectable tip that can bend up to 90 degrees, allowing for guidewire placement in hard-to-reach branches of the coronary and peripheral anatomy. Physicians turn a control knob on the handle to mechanically deflect the tip and precisely direct the catheter toward a specific location. The catheter’s coiled torque shaft provides back-up support, giving the physician more focused “pushability” and providing greater control when crossing a full range of lesions. With Venture, some patients may now be treated through minimally invasive procedures, rather than having to undergo bypass surgery.

• Synthetic Blood International (Costa Mesa, California) said that study data suggest that its perfluorocarbon blood substitute and therapeutic oxygen carrier, Oxycyte, improves cognitive recovery following traumatic brain injury in a fluid percussion injury model. In the study, rats administered Oxycyte at 4.5 ml/kg and 9.0 ml/kg dose levels showed significantly better performance in a water maze test and had fewer dying neurons in the brain than control animals treated with a saline solution. Additionally, the group receiving Oxycyte at the higher dose maintained mean arterial blood pressure at a relatively higher level, which could indicate a further improvement in the cerebral blood flow after traumatic brain injury. Synthetic Blood confirmed plans to initiate a Phase II proof-of-concept study to evaluate the safety and biological effects of Oxycyte in patients with traumatic brain injury.

• Toshiba America Medical Systems (TAMS; Tustin, California) has started commercial shipments of its Aquilion LB computed tomography (CT) scanner in the U.S. The company received FDA marketing clearance for the scanner in March. TAMS said the large-bore, multislice CT scanner delivers high-quality images in all anatomical planes and achieves what it termed “the industry’s best low-contrast resolution using the lowest dose.” With the industry’s largest bore opening of 90 cm and a 70 cm acquired field-of-view, TAMS said the Aquilion LB makes it possible to accurately scan patients of all sizes in various positions. The larger field of view eliminates hidden anatomical areas for improved diagnosis and simulation, the company said. Building on the technological design of Toshiba’s original Quantum multi-row detector, the QuantumPlus detector features additional channels which provide for the larger field-of-view and is the only detector to provide three different slice-width acquisitions, enabling the Aquilion LB CT to acquire isotropic images.

• TriPath Imaging (Burlington, North Carolina) said researchers from the Johns Hopkins Medical Institutes (Baltimore) and Massachusetts General Hospital (Boston) reported preliminary results from two retrospective research studies that yielded “good news” in the detection of cervical cancer. The researchers tested cervical cytology specimens with TriPath’s ProEx C biomarkers, monoclonal antibodies that detect over- expression of proteins that is associated with aberrant S-phase induction. The biomarkers yielded a 70.6% to 95% improvement in sensitivity for detection of biopsy evidence of high grade cervical intraepithelial neoplasia (CIN2+) when compared to a high grade abnormal cytology classification of HSIL+, and a greater than 110% improvement in calculated Positive Predictive Value for detection of CIN2+ as compared to all atypical and abnormal cytology classifications combined, defined as ASCUS and higher. Preliminary results and new in-house research studies using the ProEx C biomarkers for testing of cervical cytologic and tissue specimens were presented at the 31st European Congress of Cytology in Paris.

• Venetec International (San Diego) said a new study published in the current issue of the Journal of the Association of Vascular Access shows that its StatLock Arterial Select catheter securement device reduces dislodgements and unscheduled restarts of arterial catheters by nearly 49% – making patients safer and protecting healthcare workers against accidental needlesticks. The study concluded these benefits could be achieved at essentially no additional cost. In the study, the unscheduled restart rate for a patient group whose arterial catheters were secured with tape was compared to the rate for patients whose catheters were secured with StatLock. The restart rate for tape-secured catheters was 25%. The rate for StatLock-secured catheters was 12.8% – a 48.8% improvement.