Spectranetics (Colorado Springs, Colorado) completed enrollment of the PELA (Peripheral Excimer Laser Angioplasty) study, which tests the use of excimer laser angioplasty to treat blocked arteries in the upper leg. The randomized trial compares the safety and efficacy of the excimer laser with conventional balloon angioplasty to balloon angioplasty alone in treating total occlusions at least 10 cm long of the superficial femoral artery. PELA includes a 12-month follow-up for all patients, with U.S. regulatory approval anticipated in 2003. The study was performed at 14 U.S. and five European hospitals.
Spectranetics also said it is concluding its LARS (Laser Angioplasty for Restenosed Stents) trial at 138 patients in light of recent FDA approval to market the company's products to clear out restenosed coronary stents prior to brachytherapy treatment. It said it will continue to follow all 138 LARS patients through the study's nine-month follow-up period.
Elsewhere in the product pipeline:
Alliance Pharmaceutical (San Diego, California) said that as a result of a successful pre-approval inspection of its manufacturing facility, the company received a letter stating that the Los Angeles District Office of the FDA is recommending approval for Imavist (AFO150), an ultrasound contrast agent. Imavist is intended to increase the diagnostic value of echocardiography by providing more detailed images of the heart than can be achieved with standard (non-contrast) ultrasound imaging.
Angiogene (Montreal, Quebec) began enrolling patients into Beta-Impact, its Phase I/II trial for the prevention of restenosis following balloon angioplasty. This open-label trial is aimed at assessing the safety, tolerability and efficacy of delivering the Angiogene Oliglow radiotherapeutic compound locally into the coronary wall. Oliglow is a beta-emitter source that has demonstrated in preclinical studies optimal retention properties in the arterial wall, and has shown effectiveness in inhibiting smooth muscle cell proliferation, a key cause of restenosis.
Applied Digital Solutions (Palm Beach, Florida) released details of its rollout plan for Digital Angel, which it says is "a combination of advanced biosensor technology and web-enabled wireless telecommunications linked to Global Positioning Systems (GPS)." By using advanced biosensor capabilities, the company said that Digital Angel would be able to monitor important body functions — such as temperature and pulse — and transmit that data, along with accurate location information, to a ground station or monitoring facility.
Baxter Healthcare (Deerfield, Illinois) released a new medication infusion pump software developed to provide features to enhance patient safety through the reduction of intravenous medication programming errors. The software, the Colleague Guardian Feature, is available on all Colleague CX (color) infusion pump models. The Colleague Guardian Feature was developed to allow a hospital to enter its own standard drug infusion protocols into the Colleague drug library. This allows hospitals to set customized dose limits for more than 90 different drug protocols. When hospital staff administers a medication through the infusion pump, the system compares each dose entered against the hospital-defined limits. If a dose is programmed outside these limits, the Colleague Guardian Feature provides a visual and audible alarm, informing the clinician that the dose is outside the hospital formulary's recommended range.
CADx Medical Systems (Basingstoke, UK), a subsidiary of Shire Pharmaceuticals Group plc, received an "approvable" letter from the FDA for its Second Look computer-aided detection system for mammography. A screening tool that provides radiologists with a computerized second review of mammograms, the system highlights potential areas of concern on a mammagraph report, calling attention to subtle changes in tissue that may indicate the presence of cancer. After viewing mammograms, radiologists refer to the mammagraph to assist in a course of treatment. The letter applies to the premarket approval application for Second Look, which was filed in a modular format over the last two years. Marketing clearance for the Second Look system is subject to final labeling discussions with the FDA.
Cardiac Science (Irvine, California) was granted three additional U.S. patents related to its automatic external defibrillator products, covering the company's Powerheart technology, an external hospital monitor that provides continuous monitoring of heart rhythm to deliver a shock without the need for help from a hospital attendant. The patents include No. 6,301,502, which covers a defibrillation system that collects and downloads patient information to a central database; No. 6,304,780, which covers the concept of an external module used to perform diagnostic testing of a defibrillator; and No. 6,321,113, which covers proprietary methods for rapidly downloading of information stored in the memory of the device to a base station and transmission to another location without need to remove the AED from service. Cardiac Science has 10 additional patents pending.
Celsion (Columbia, Maryland) treated all 169 patients required in its pivotal benign prostatic hyperplasia Phase II trial. It also submitted to the FDA two of the three required modules necessary to complete the premarket approval application. Celsion is focused on medial treatment systems for cancer and other diseases by means of targeted heat technology delivered by microwave systems.
Cepheid (Sunnyvale, California) was issued U.S. patent 6,312,929, broadly covering compositions and methods that ensure, within a single, closed reaction-tube, the integrity of all the chemical reagents used for PCR-based DNA detection. Eliminating the need for other chemicals in a second reaction tube, the validation capability is crucial for making DNA testing broadly applicable to human diagnostics that require marketing clearance by the FDA. With a prototype expected to be available to the U.S. Department of Defense at the end of this year and commercial availability slated for 2003, Cepheid's GeneXpert will deliver results from a raw sample in 30 minutes, enabling time-critical DNA tests at the point of need. Current techniques can take hours to several days. Developed by Cepheid and its partners, potential applications for the GeneXpert system include clinical diagnostics, food testing, environmental testing and biodefense.
Cholestech (Hayward, California) said that the results of a clinical evaluation of its liver function test, Alanine Aminotransferase (ALT), were comparable to those obtained using a conventional laboratory method. The results of the study, conducted by researchers at the specialized lipid laboratory of the Stanford University School of Medicine (Palo Alto, California), were announced at November's American Heart Association (Dallas, Texas) scientific sessions in Anaheim, California. Researchers evaluated the accuracy of rapid fingerstick methodology for measuring ALT using the Cholestech L-D-X and found results comparable to those of standard tests used in the center's lipid laboratory. The ALT measured by fingerstick sample can be combined with lipid testing to effectively manage lipid-lowering and other therapies, the researchers said. The product received CLIA-waived status in June. The test is run on the Cholestech L-D-X System, a telephone-sized device that can conduct multiple simultaneous diagnostic tests from a single drop of blood, with results in less than five minutes.
Ciphergen Biosystems (Fremont, California) introduced its new ProteinChip Biomarker System, calling it "the first protein biochip-based system on the market enabling biomarker pattern recognition analysis." The system uses Biomarker Patterns software, which automates pattern recognition-based statistical analysis methods to correlate protein expression patterns from clinical samples with disease phenotypes.
Collateral Therapeutics (San Diego, California) highlighted results from a recent review article, published in the Aug. 31 issue of Circulation Research, a journal of the American Heart Association, that provides a review of safety data from clinical trials of cardiovascular gene therapy. The review article reports that clinical trials of cardiovascular gene therapy, whether using viral or nonviral vectors, have thus far disclosed no evidence indicative of inflammatory or other complications, including death, directly attributable to the vector used. Despite the fact that initial trials of cardiovascular gene therapy targeted patients with end-stage vascular disease, including critical limb ischemia and refractory myocardial ischemia, the mortality for patients enrolled in trials of cardiovascular gene therapy reported to date appears to compare favorably with mortality for similar groups of patients in contemporary controlled studies of medical or interventional therapies, the company said. Collateral Therapeutics develops gene therapy products for the treatment of cardiovascular diseases.
Conceptus (San Carlos, California) said data published this month in the medical journal Fertility and Sterility supports the theoretical mechanism of action of its non-incisional permanent birth control device Essure, based on a study done with 43 women several weeks before a planned hysterectomy. It concluded that the tissue response is predictable, occlusive in nature, was localized to the device and should provide long-term anchoring of the device. The company said also that a second study released in the Australia and New Zealand Journal of Obstetrics and Gynecology provides evidence of acceptance of this permanent birth control method in clinical trials. The procedure was rated very highly by a group of 111 women who had the Essure micro-inserts placed at the first investigational site to enroll patients. Three and six months after the procedure, 99% rated their comfort with the micro-inserts as "very good" to "excellent." Essure is an expanding micro-insert consisting of a stainless steel inner coil, an outer coil made from nitinol and polyethelene terephthalate fibers. The device is inserted through the cervix into the fallopian tubes through a catheter that covers the guidewire, from which the device is then released.
Confirma (Kirkland, Washington) completed enrollment of its breast cancer clinical study for evaluating Digital Tissue Recognition, a technology that analyzes magnetic resonance imaging data. The company will now work with five independent radiologists to analyze Digital Tissue Recognition for its ability to assist in better determining the extent of disease in cancer patients. Digital Tissue Recognition uses a known tumor site in the individual to create a unique tumor signature to search for and identify other sites of disease, providing physicians with more information that may affect treatment and surgical planning, as well as disease management.
Corvas International (San Diego, California) said results from a Phase IIa study show its anticoagulant rNAPc2 appears to be safe and well tolerated when administered to patients prior to elective percutaneous transluminal coronary angioplasty. The data also showed that, in contrast to standard therapy with heparin and aspirin alone, rNAPc2 effectively suppresses the formation of thrombin, a serine protease that is a factor in causing blood to clot.
Curon Medical (Sunnyvale, California) completed two U.S. clinical studies evaluating the efficacy of its Stretta System for the treatment of gastroesophageal reflux disease (GERD). The first, a randomized, sham-controlled Stretta trial, was a double-blind study conducted at eight institutions beginning in May 2000. The data demonstrate that the Stretta patient group reported a significant reduction in overall GERD symptom scores and a marked improvement in patient satisfaction, while the sham group remained unchanged. The second study was the Stretta Registry, an extensive patient database collected from 33 institutions representing 590 patients treated with the Stretta procedure since February 1999. It showed the Stretta procedure results in significant GERD symptom control and patient satisfaction over the long term.
Cyberonics (Houston, Texas) reported preliminary results of the pilot clinical study of vagus nerve stimulation (VNS) for the treatment of Alzheimer's disease (AD) at the Swedish Medical Society meeting in Stockholm, Sweden. After three months of VNS, eight of 10 patients with AD responded, where response is defined as an improvement in or no worsening of AD symptoms based on the AD Assessment Scale-cognitive (ADAS-cog). Of the eight responders, six had improvements in their symptoms of AD and two had no worsening. After six months of VNS, seven of the eight continued to sustain response by having improvements in symptoms compared to their baseline ADAS-cog. Patients with AD typically worsen nine points in the ADAS-cog each year. The 10 patients had a median improvement in the ADAS-cog of three points after six months of VNS. Sahlgrenska University Hospital (Gothenburg, Sweden) implanted and treated the first patients with AD in the VNS pilot study, which consists of a three-month acute period with subsequent long-term follow-up.
Diametrics Medical (St. Paul, Minnesota) received 510(k) clearance from FDA for a glucose test for its IRMA SL Blood Analysis System. The company also filed a 510(k) application with the FDA for a lactate test. The IRMA system is a portable blood analyzer that performs a broad range of time-critical tests at bedside, including blood gases, electrolytes, chemistries and hematocrit in a variety of test panel configurations. The new glucose test, which will be combined on a panel with electrolyte tests, is expected to be commercially available early this year.
Esperion Therapeutics (Ann Arbor, Michigan) reported positive preliminary findings from a Phase IIa study of ETC-588, or LUV (large unilamellar vesicles), a biopharmaceutical currently in development to treat acute coronary syndromes. Esperion plans to continue clinical development. Based on the results of the study involving 34 patients, an optimal dosing schedule of every seven days has been defined for future study. In addition, Esperion concluded from a sub-study that establish the feasibility of using MRI to assess vascular structure of the carotid arteries, and that technology will be used in future studies of ETC-588 to assess a primary endpoint of rapid changes in plaque volume and composition.
HealthTronics Surgical Services (Marietta, Georgia) said the FDA received its premarket approval application for the treatment of tennis elbow with the OssaTron, the company's orthopedic shock wave device. OssaTron already is approved to treat plantar fasciitis. OssaTron applies high-energy shock waves, a process known as orthotripsy, to tissues in the elbow, causing microscopic damage that leads to growth of new blood vessels into the area and allows tissue-healing cells to repair the chronic injury. The company anticipates that the FDA will act on the PMA application sometime in 1H02.
Hologic (Bedford, Massachusetts) released a new operating system for its DirectRay Console. Enhancements to the console, which interfaces with the DirectRay digital detector and the system X-ray exposure equipment, enable the acquisition and transmission of patient, exam and image data in a digital format, leading to better image handling and improved productivity, the company said. The new software includes an optional Inverse Topography feature, designed to optimize the presentation of both soft tissue and bone in the same hard- or soft-copy image; FastPrep, allowing more accurate image capture and fewer retakes; new image display features including enhanced Merrill's Atlas Exam Coach features; additional print formatting options; enhanced output queue management features; network access to administrative information; and support for the new digital X-ray DICOM object.
Imagyn Medical Technologies (Irvine, California) received 510(k) clearance from the FDA to sell isosleeve, a sterilized custom preloaded needle delivery system for prostate brachytherapy. Meant for use with Imagyn's isostar iodine-125 brachytherapy seeds, this delivery system will be shipped to the customer ready to use to eliminate much of the pretreatment preparation. The isosleeve system contains a digital record with each order showing the loading pattern of each isosleeve. The sleeve itself can easily be removed and re-inserted for a visual check, a feature new to brachytherapy. The design of the tip of the isosleeve mechanically retains the seeds and spacers, eliminating the use of the traditional bonewax; and provides tactile feedback to the physician during implantation.
ImmuCell (Portland, Maine) said the U.S. Department of Agriculture approved Tip-Test: BLV, the company's Bovine Leukemia Virus antibody test kit. The product licensure represents ImmuCell's fourth USDA-approved product for the dairy and beef industry. Prevalent in U.S. dairy and beef herds and can cause Leukosis, a severe and often fatal complication in up to 5% of infected cattle. Tip-Test: BLV is the company's second diagnostic product using its rapid on-site testing technology. In addition to operating an animal health business, the company has obtained UK regulatory approval to sell Crypto-Scan, a product used in the detection of Cryptosporidium in drinking water. ImmuCell also has demonstrated preliminary efficacy in an open label, Phase I/II efficacy study of DiffGAM, an alternative to antibiotics in the treatment and/or prevention of Clostridium difficile-associated diarrhea in humans.
Inamed (Santa Barbara, California) reported that the European Patent and Trademark Office's technical board of appeal ordered a patent for the company's Universal Gastric Band, the Lap-Band Adjustable Gastric Banding System, a laparoscopic implant for the surgical treatment of morbid obesity. The Lap-Band is a minimally invasive intervention that requires no cutting or stapling of the stomach, or gastrointestinal re-routing to bypass normal digestion, and is reversible. It is marketed worldwide by the company's BioEnterics division. The European patent grant, expected within the next few months, gives the company broad protection against imitators with important and broad protection from imitators. The company previously received patents from the U.S., Australia and Canada. The company in late November said that the Lap-Band is its fastest growing line and will drive a 50% to 60% increase in sales for 2002.
Inlet Medical (Eden Prairie, Minnesota) said its Inlet CloseSure Procedure Kit was cleared for sale in Canada. The kit is designed to reduce the risk of herniation into trocar ports, a complication of laparoscopic procedures. The kit allows the physician to close the wound in less time, without leaks or other complications, according to the company, with patient recovery time reduced and comfort levels elevated. The CloseSure Kit has been available in the U.S. since October 1998. In Canada, it will be sold through a distributor and is expected to be available this month. Inlet develops and markets products for pelvic reconstructive surgery for women.
InSpeck (Montreal, Quebec) launched the Footshape, a new system for digitizing 3-D plantar surfaces to create virtual corrections and numerically produce foot orthoses. An optical digitizer is used to acquire the bottom of the feet in a fraction of a second and the system is intended to replace traditional imprint methods (using, say, plaster or foam). The digitized data of the foot is electronically transmitted to the orthoses manufacturer who then can create the foot orthoses numerically. InSpeck develops systems supporting applications in biomedical research and medical imaging for modeling, animation, multi-media and electronic games.
Kensey Nash (Exton, Pennsylvania) began the PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) randomized trial for its TriActiv Distal Protection System. It will take place at up to 50 sites, enrolling up to 800 patients who will be randomized to either the TriActiv System or the traditional standard of care at each hospital. Training of the sites is ongoing and will continue over the next several months. The TriActiv System is designed to prevent heart attacks during the treatment of saphenous vein grafts in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The device incorporates three features to address the common problem of distal embolization: a balloon protection guidewire, a flush catheter and an extraction system to remove debris found in the grafts.
Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) made PreGen-26, a DNA-based colorectal cancer test, available to physicians and their patients. The test is based on Exact Sciences' (Maynard, Massachusetts) genomics-based technology. PreGen-26 targets Hereditary Non-Polyposis Colorectal Cancer (HNPCC), an inherited predisposition to develop colorectal cancer. People with this syndrome have an 80% lifetime risk of developing the disease. PreGen-26 is not a predictive test for colorectal cancer, but rather is intended to detect the presence of actual disease.
Matritech (Newton, Massachusetts) launched its NMP22 BladderChek bladder cancer test internationally. BladderChek provides a physician with the results during an appointment as opposed to current tests performed in a central laboratory that take two to three days. The test is intended for use in conjunction with cystoscopy, the primary clinical procedure used by urologists to detect bladder cancer. BladderChek, along with cystoscopy, provides urologists with an improved tool for detecting bladder cancer compared to the voided urine cytology test currently in use, the company said. Last year, the FDA approved the NMP22 laboratory-based test for use as an aid in identifying bladder cancer in previously undiagnosed individuals who have symptoms or risk factors, making it the only urine-based test to have FDA approval for this indication.
NuVasive (San Diego, California) received 510(k) clearance from the FDA to market two new components of its minimally invasive spine surgery system. The NeuroVision Intraoperative Nerve Guidance System incorporates software and a graphical user interface to enable the surgeon to navigate past nerves while advancing cannula to access the spine. NeuroVision provides intraoperative electromyographic (EMG) nerve surveillance to assist in the location and evaluation of spinal nerves during percutaneous surgery of the spine by administering low amperage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves. The Hemi-Arc Surgical Navigator enables the surgeon to accurately guide cannulae and surgical instruments to targeted areas of the spine through alignment with radiographic imaging. Hemi-Arc serves as a trajectory guide instrument holder that is aligned with the operative site using real-time or near real-time image intensified C-arm fluoroscopy.
Nymox Pharmaceutical (Maywood, New Jersey) said studies indicate that the Nymox AlzheimAlert test not only helps in the diagnosis of Alzheimer's disease (AD), but also shows promise in monitoring progression of the disease. Data from independent studies of the AlzheimAlert test were presented at the Third Manhattan Alzheimer's Disease Conference in New York. The company said the studies indicate that the AlzheimAlert test values increase with disease progression, suggesting that it may become a key tool for monitoring emerging therapies for AD. AlzheimAlert uses urine samples to detect the levels of neural thread protein, which are elevated in patients with AD.
PenJet (Los Angeles, California) received a U.S. patent for mixing a lyophilized (freeze-dried) drug with a diluent in a needleless jet injector prior to administration. The PenJet needleless injector is packaged with a lyophilized drug in its integral ampoule along with a reagent (diluent) in a separate carrier. Prior to administering an injection, the user docks the diluent housing to the front of the PenJet ampoule. The reagent is pushed into the ampoule containing the lyophilized product, liquefying it so it can be injected. The shuttle system allows the two components to be thoroughly mixed by transferring it back and forth a few times. After mixing, the user removes the reagent housing from the end of the PenJet and administers a needleless injection. The company said foreign patents are pending.
Radiance Medical Systems (Irvine, California) enrolled the first U.S. patients in its peripheral vascular clinical study, RAPID (Radiation After PTA Is Done). The three de novo lesion cases were completed at Rush Presbyterian Hospital (Chicago, Illinois), and all involved the beta irradiation of a portion of the superficial femoral artery using Radiance's RDX System. Radiance believes this was the first U.S. use of beta radiation to treat arterial stenosis in a peripheral vessel.
Refractec (Rockville, Maryland) reported data presented on conductive keratoplasty (CK) received an "approvable" recommendation from the FDA's ophthalmic device panel. The CK procedure uses radiofrequency energy, instead of a laser, to reshape the cornea and treat hyperopia, or farsightedness.
Siemens Medical Solutions' (Danvers, Massachusetts) Electromedical Systems Division introduced the Infinity Micro2+ pulse oximeter. Representing what Siemens calls "the next generation in pulse oximeters," it offers motion tolerance and digital signal processing for ambulatory, pediatric, and neonatal patients. It also supports telemetry monitoring, addressing the problems of motion and resulting artifact (false readings) that occur in ambulatory adult patients as well as in cold, shivering, or active infants.
Somanetics (Troy, Michigan) received FDA clearance to market its CorRestore patch, an implant designed for use in cardiac repair and reconstruction, including surgical anterior ventricular endocardial restoration (SAVER), a treatment for patients with certain types of congestive heart failure. During SAVER, the surgeon restores the enlarged, poor functioning left ventricle to more normal size and function by inserting an implant, in most instances, or closing the defect directly. Somanetics expects the first implantation of the CorRestore patch this month, with a broader market launch in 2Q02.
St. Jude Medical (St. Paul, Minnesota) received FDA approval to market the Identity pacemaker, the company's newest pacemaker product line. Full U.S. market release is scheduled for 1Q02. The first Identity pacemaker implant in the U.S. was performed in late November at Deborah Heart and Lung Center (Browns Mills, New Jersey). The Identity family, expands the company's AFx feature set to include a suite of arrhythmia diagnostics. AFx features are designed to help physicians better manage pacemaker patients suffering from atrial fibrillation.