BioEnterics (Carpinteria, California), a subsidiary of Inamed (Santa Barbara, California), has received premarket approval (PMA) from the FDA for its Lap-Band Adjustable Gastric Banding System for the treatment of severe obesity. "Since 1993, this product has been used by over 60,000 patients worldwide, and it has a well-documented track record of safety and efficacy," said Richard Babbitt, chairman of the board and chief executive officer of Inamed.
The company says the system is a less-invasive approach to obesity surgery, filling the gap between nonsurgical treatments such as dieting, exercise and drugs and more invasive surgical procedures such as stomach stapling or gastric bypass. It includes an adjustable silicone band that is placed by laparoscopic keyhole surgery around the upper part of the stomach to create a small gastric pouch. This limits food consumption and creates an earlier feeling of fullness.
The band is inflatable and connected to an access port placed close to the skin that allows surgeons to adjust the system to meet individual patient needs. The procedure is reversible and does not require cutting or stapling of the stomach, or gastrointestinal re-routing to bypass normal digestion. Patient benefits include reductions in surgical trauma and complications, less pain and scarring, and shorter hospitalization and recovery time compared to more invasive obesity surgeries.
"It's designed to simply restrict how much someone can eat," said Ellen Duke, president and CEO of BioEnterics. Duke said that the pouch above the band is only about 15 millimeters in size "so it definitely restricts how much you can eat at one time." However, Duke stressed that the success of the system is largely based on patient compliance.
Paul O'Brian, MD, a professor of surgery at Monash University (Melbourne, Australia), has treated more than 800 people with the device over a seven-year period. O'Brian said his experience with the device has been positive. "It has been a very safe procedure; we've had no deaths associated with the operation or complications," he said. "We've actually got follow-up data on nearly 99% of our patients. In terms of weight loss, they've lost just over 50% of their excess weight [typically 30 to 40 kilograms] and they've maintained that weight loss over the six years that we've followed them so far."
Another positive O'Brian noted was a change in health, especially in quality of life. He noted that the significant weight loss helped to reduce serious health problems – such as high blood pressure, Type 2 diabetes, asthma and sleep apnea.
O'Brian reported that his team had a 12% re-operation rate. However, he said that the frequency of re-operation has decreased during the 800 procedures. "We were re-operating on about 20% of the patients throughout the first 400 and that number has decreased to 5% of the patients over the last 400."
O'Brian noted the three greatest aspects of this device to him were "the fact that it's adjustable; it's a laparoscopic procedure; and it's reversible, unlike a gastric bypass." He said that the procedure takes only about 40 minutes to perform.
To facilitate optimal patient results and due to the learning curve with the procedure and patient management, the system will initially be available at a limited number of centers this year. The conditions of the PMA approval require that surgeons complete a company-authorized training program. This includes workshops and proctoring, as well as training for program coordinators.
Currently, the device is approved only for severely obese patients, those with a body mass index (BMI) of 35 or more. The U.S. market of severely obese patients is in the 11 million range. However, Duke said that there is a great potential to increase these numbers by including the obese market and diabetics. She said it is possible that the usage for the device would go below 35 BMI in the future. The company estimated that in the U.S. alone there are more than 39 million people classified in the obese category.
Duke estimated the cost of the device at around $2,000 and said the company expects a U.S. release to take place in 3Q01.
Elsewhere in the product pipeline:
CardioVasc (Menlo Park, California), developer of small-diameter vascular stent-grafts and surface treatments to promote rapid endothelialization of implants, said that the first patients have been treated with its stent-graft device. These devices include a surface treatment designed to enhance endothelial cell adhesion after implantation. CardioVasc is initially targeting lesions in diseased saphenous vein grafts. Christian Hamm, MD, of Kerckhoff Heart Center (Bad Nauheim, Germany) and lead investigator of the clinical trial, commented, "We believe that the ability to grow a healthy endothelium may be very important in the long-term potency of covered stents."
CareCentric (Atlanta, Georgia) released its new Windows-based home infusion pharmacy software. The new system, called PharmMed, provides functions to enter, process and manage prescriptions and related orders. CareCentric provides freestanding, hospital-based and multioffice home health care with information solutions enabling home-care operations to use integrated financial, operational and clinical information.
CareScience (Philadelphia, Pennsylvania) released its newest product, called Optimal Decisions, based on the work of professors at the Wharton School of Business (Philadelphia, Pennsylvania) and George Washington University (Washington). Optimal Decisions integrates decision-making methods into web-based software that allows groups to rapidly determine the best decision for a given course of action, the company said. According to CareScience, pharmaceutical and biotechnology companies can use the system to improve the complex decisions of drug development, such as determining the best trial designs, patient populations, comparators, study sites and go/no-go decisions. Health care institutions can use the system to improve quality, reduce costs and make optimal formulary decisions, the company said. Optimal Decisions incorporates clinical, economic and humanistic information so that hospitals understand both the financial impact of a drug on its pharmacy budget, and also the impact and benefits of the drug on the overall health system. Optimal Decisions is available as a component of the company's Lifecycle Decision System product line. CareScience provides online care management services to the health care industry.
ChromaVision Medical Systems (San Juan Capistrano, California), a provider of automated cell-imaging systems and maker of the Automated Cellular Imaging System (ACIS), reported the launch of a private network system that allows clinicians to review and analyze ACIS-generated images from remote locations. The initiative will enable physicians to send patient specimens to a central laboratory where technologists will prepare slides and perform ACIS image capture. The resulting data and images will then be made available to physicians in other laboratories, pathology practice groups or community hospitals through a secure local or wide area network or the Internet. Development of this network expands the market for ChromaVision by extending its products to physicians and laboratories whose test volumes would not otherwise support a complete ACIS system. Chairman and CEO Douglas Harrington, MD, said, "This network brings to virtually every pathologist and physician a revolutionary tool that in another era would have only been available through a university medical center or leading cancer center." ChromaVision's ACIS system offers the ability to detect, count and classify cells of clinical interest based on color, size and shape.
CryoCath Technologies (Kirkland, Quebec), a developer of cryotherapy technologies for treating cardiovascular disease, reported receiving U.S. patent No. 6,241,718 for a new method of treating restenosis. The patent, according to Steven Arless, president and CEO of the company, creates "a significant issue for any company wishing to develop catheter technologies to deliver cryoenergy as an anti-restenosis therapy without CryoCath's participation ... the restenosis patent builds on our field-dominating Friedman patent, by protecting our largest target market segment." The patent applies to any method that uses temperatures in the range from 0 degrees C to minus 120 degrees C, such that the vessel and surrounding tissue retain the ability to reproduce and repair themselves following treatment thereby inhibiting restenosis. The company is pursuing a safety and feasibility study for the treatment of peripheral restenosis at the Montreal Heart Institute (Montreal, Quebec) and St. Michael's Hospital (Toronto, Ontario), with patient enrollment to be completed by year-end.
CyberCare (Boynton Beach, Florida) said its CyberCare System successfully transmitted simultaneous voice, video and medical data on the Internet2 – the next-generation Internet – as part of a global health project. The connection was initially made between the Georgia Institute of Technology (Atlanta, Georgia) and Taipei Medical University (Taipei, Taiwan), and it was then linked over a gateway to the Medical College of Georgia (Augusta, Georgia). In addition to the live video link, the system transmitted medical data, including patient heart and lung sounds, using CyberCare's electronic stethoscope. Internet2 is expected to bring major improvements in the areas of data security and reliable bandwidth needed for high-quality video connections when commercially available. During the development stage, Internet2 is used exclusively for research purposes among selected institutions. The goal of the trials, according to CyberCare, is not to replace face-to-face medical contact, but to create a viable telemedicine network of global resources, incorporating multiple individuals in the health care delivery process, resulting in cost reduction and improvement in the quality of patient care.
Diametrics Medical (St. Paul, Minnesota) said it has filed a 510(k) application with the FDA for a glucose test for the IRMA SL Blood Analysis System. The IRMA system is a portable blood analyzer that performs a range of time-critical tests at the patient's bedside, including blood gases, electrolytes, chemistries and hematocrit in a variety of test panel configurations. Diametrics makes blood and tissue diagnostics products.
Galil Medical (Woburn, Massachusetts) has released a new technology that the company said represents the latest advance in its third-generation prostate cancer cryotherapy system, SeedNet Treatment Planning Simulator (STPS). This software, developed and marketed by Galil Medical, provides a 3-D thermodynamic simulation of cryotherapy. The SeedNet procedure allows direct percutaneous insertion of ultra-thin, 17-gauge needles. The SeedNet needles are guided to their target locations through an insertion template similar to that used in brachytherapy. Galil's IceSeeds technology used by the SeedNet system destroys targeted tissue with even temperature distribution. Galil develops medical products in the field of prostate cancer therapy.
Icos-Texas Biotechnology, a partnership formed by Icos (Bothell, Washington) and Texas Biotechnology (Houston, Texas), said patients are being recruited for the company's Sitaxsentan to Relieve Impaired Exercise in Pulmonary Hypertension (STRIDE) trial, a pivotal Phase II/III study with sitaxsentan, an oral endothelin A receptor antagonist. The objective of the randomized, double-blind, placebo-controlled trial is to demonstrate the safety and efficacy of sitaxsentan as a new, once-a-day treatment for patients with pulmonary arterial hypertension. The primary endpoint is change in exercise capacity over the 12-week study period. The study also will evaluate changes in six-minute walk distance, cardiopulmonary hemodynamics and quality of life as secondary endpoints. This trial will enroll about 180 patients in North America.
Igen International (Gaithersburg, Maryland) said it is moving to expand the market for its Pathigen test kits, currently used to screen food for potentially harmful bacteria, by adapting the kits for use in rapid tests for human gastrointestinal infections in point-of-care settings, such as physicians' offices and satellite laboratories in hospitals. Company scientists recently reported the results of a study they said demonstrates that Pathigen tests detected two kinds of foodborne pathogens, Salmonella and Campylobacter, in human fecal samples without the need to grow the bacteria for 24 to 48 hours. The study also showed that Pathigen tests detected Salmonella, Campylobacter and E. coli O157 in human fecal samples at levels from 100 to 10,000 times lower than levels of these bacteria found in fecal samples from people with gastrointestinal illness. The Pathigen tests, based on the company's Origen technology, are capable of producing results in as little as 10 minutes because they eliminate the need for bacterial culture or sample handling steps such as washing. The company said that these tests for human use could help physicians diagnose foodborne gastrointestinal illness more rapidly than current methods. The tests are subject to a 510(k) approval, and the company believes it can complete development and regulatory requirements for the first Pathigen. The company is planning to develop tests for other gastrointestinal pathogens, including Cryptosporidium, Clostridium and Giardia.
Immunicon (Huntingdon Valley, Pennsylvania) has been issued U.S. patent No. 6,228,624, "Methods to Select and Transfect Cell Subpopulations," covering claims related to a method of potential importance in ex vivo gene therapy. The proprietary method uses Immunicon's nanoparticle and magnetic separation technologies. According to the company, the patent describes a method of targeting, transfecting and separating cells in gene therapy applications. Magnetic nanoparticles are coupled with a bioactive marker, which binds to specific types of cells, such as hematopoietic progenitor cells (stem cells). The particles are also coated with genetic material that penetrate the cell membranes of the target cells. Once inside the target cells, the genetic material may combine with existing cellular components to produce a therapeutically useful effect, according to Immunicon. Genetic material introduced in this manner may repair an existing genetic defect that causes a specific disease or genetic abnormality in patients. In ex vivo gene therapy, cells are first taken from the patient, treated outside of the patient's body and then returned. Immunicon is a privately held biomedical company focused on the development of tools for cancer disease management, screening and life science research.
Irvine Biomedical (Irvine, California) received 510(k) clearance from the FDA for its AFocus family of steerable diagnostic catheters. Specifically designed for mapping in the atrial regions of the heart, the AFocus catheter features a circular curve perpendicular to the catheter shaft, allowing simultaneous, circumferential electrical recording. AFocus mapping catheters enable the physician to identify electrical potential in specific anatomical atrial structures and is able to steer open and closed negating arduous sizing of atrial structures. Peter Chen, PhD, president and CEO, stated, "We believe the AFocus catheter technology will ultimately provide an effective tool in assisting with the ablation treatment of patients with paroxysmal atrial fibrillation."
LeadScope (Columbus, Ohio), in collaboration with ddplatform (Emeryville, California), has released a series of toxicity databases called ToxScope, which correlates toxicity information with structural features of chemical libraries. This creates a data mining system that incorporates the searching and browsing capabilities of the company's enterprise server. The virtual decision-making software is designed to provide access to 150,000 chemical structures and expert statistical analysis of complex data to speed the process and cut the high costs of drug discovery. The ToxScope databases encompass acute toxicity, hepatotoxicity, mutagenicity and carcinogenicity. ToxScope enables the user to make side-by-side comparisons of efficacy screening and toxicity information, use structural alerts from any source, explore chemical space of any data set and manage complex in-house data, the company said. Consulting services with ddplatform and LeadScope for data mining of the customer's internal toxicity data also are available. Lead Scope develops decision support tools for life scientists engaged in drug discovery. ddplatform is a private company of toxicology experts specializing in approaches to accelerate the discovery and development of new drug candidates.
Medical Carbon Research Institute (MCRI; Austin, Texas) has received premarket approval from the FDA for its On-X aortic valve. The approval makes MCRI's pyrolytic carbon On-X aortic valve available in the U.S. as a replacement for diseased heart valves. The On-X valve uses pure On-X pyrolytic carbon in a hemodynamic bileaflet design. The design of the On-X valve design mimics the contours and performance of the natural valve as closely as possible.
Medtronic (Minneapolis, Minnesota) released its InSync III cardiac resynchronization system in the European, Canadian and Middle Eastern markets. InSync III is an implantable device designed to improve the pumping capability of heart failure patients with ventricular dysynchrony. The company said the InSync III system is the first to deliver cardiac resynchronization therapy that incorporates "activation flexibility," allowing physicians to program and control the beating action of the right and left sides of the heart independently, the company said. It also is the first to include heart failure-specific diagnostic capabilities that monitor a patient's heart rate trends and activity levels. Medtronic also reported the U.S. launch of its R2 Rapid Exchange Balloon Dilatation Catheter with Perfusion Technology and its counterpart, the D2 Over-The-Wire Balloon Dilatation Catheter. The R2 and the D2 low compliance, extended pressure balloon catheters join the R1 and D1 semi-compliant balloon catheters, thus expanding the range of balloon angioplasty treatment options now available from Medtronic. "The R2 and D2 carry over many of the same delivery-enhancing features of the R1 and D1, while incorporating the strongest performance characteristics of both semi-compliant and non-compliant balloon catheters. The result is a highly versatile solution that meets both patient needs and physician preferences," the company said in a statement. It said that the primary difference between the R2 and D2 vs. other products on the market is its balloon material, AVEd Plus, which offers low compliance and an extended pressure range, without compromising profile, flexibility, trackability or refold capabilities.
Opt-e-scrip (Morristown, New Jersey) received U.S. patent No. 6,242,463 for an application covering its single-patient drug testing system. The patent covers the use of a single-patient clinical trial linked to a database of combined, previously conducted single-patient trials. The purpose of the testing is to help doctors optimize therapy for individual patients, while at the same time helping HMOs and other payers evaluate chronic-care drugs before paying for them on a recurring basis. The technology is delivered through the first-ever "clinical trial in a box," which uses a randomized, double-blind, multi-crossover design that has sufficient statistical power to determine the most effective and least costly drug for an individual patient, the company said. According to Opt-e-scrip, when commercialized, the system will provide doctors with statistically valid information on how each patient responds to a specific drug compared to a placebo pill, an alternative drug or a different strength of the same drug. This, in turn, should reduce reliance on pharmaceutical company data gathered from group clinical trials, which only include patients with similar age, sex and disease-state characteristics. Opt-e-scrip develops test kits for more than 20 chronic-care categories, including kits for allergic rhinitis, gastroesophageal reflux disease, depression and osteo-arthritis, which all are currently in pilot testing.
Osteometer BioTech AS (Copenhagen, Denmark) reported receiving FDA clearance for its N-MID Osteocalcin ELISA product, a test for osteocalcin, a material synthesized by the bone-forming cells and therefore a bone formation marker. The test detects both intact osteocalcin as well as the large N-MID fragment, providing stable and reproducible data of bone formation. Klaus Eldrup-Jorgensen, president and CEO, said the company had developed more than five years of marketing experience with the test in Europe and this "stimulated us to bring the clinical data to the FDA." He added, "We experience an increasing demand for this test in Europe, partly caused by clinical trials of drugs stimulating bone formation, and with this recent support from the FDA, we have improved our position significantly in this emerging market." The company also markets a range of bone resorption markers applicable to basic and clinical research.
Palomar Medical Technologies (Burlington, Massachusetts) reported receiving FDA clearance for its SLP 1000. The SLP 1000 previously received clearance for treating hair, vascular and pigmented lesions, facial, spider and leg veins and other dermatological conditions. The system uses a combination of super long-pulse, three-phase contact cooling, photon recycling and other patented technology designed to ensure safe and effective treatment. The fiber-optic delivery handpiece, weighing a few ounces, is designed for comfort and reduced fatigue. The 12 mm-spot-size handpiece delivers high-repetition pulses to the skin for rapid coverage of large areas. It also has a handpiece with a 4 mm-spot size for treating small to medium-sized leg veins, facial veins, and a handpiece with an 8 mm-spot size for treating large leg veins. Louis Valente, chairman and chief executive officer of Palomar, said, "We continue to add trained sales personnel and distributors, giving Palomar access to world markets. We are on target to execute and continue our strategic plan during 2001 and beyond with a strong balance sheet and the best laser hair removal technology in the industry."
Raymedica (Minneapolis, Minnesota) said it has received approval to begin a clinical trial for its PDN prosthetic disc nucleus in Canada. The PDN device is designed to treat patients with degenerative disc disease and offers an alternative to standard spinal fusion treatment. Three Canadian sites will participate in this study: the Orthopedic and Arthritic Institute (Toronto, Ontario), the Queen Elizabeth II Health Sciences Center (Halifax, Nova Scotia) and the Ottawa Health Research Institute (Ottawa, Ontario). The device is made of a special hydrogel core that absorbs fluid and expands when implanted in a surgically prepared disc nucleus cavity. This polymer core is encased in a polyethylene jacket that helps maintain device shape when subjected to heavy loading in the spine. The biomechanical interaction of the expanding hydrogel and constraining jacket is designed to provide the lifting force necessary to maintain or increase disc height, while remaining flexible enough to permit normal range of motion and provide cushioning to the affected vertebral segments.
St. Jude Medical (St. Paul, Minnesota) began the first U.S. implants of its Symmetry Bypass System Aortic Connector, a sutureless anastomosis device for coronary artery bypass grafting (CABG) surgery. The system was developed by St. Jude's cardiac surgery division, anastomotic technology group. Two procedures were performed at the Mayo Clinic (Rochester, Minnesota), on May 24, following FDA 510(k) clearance to commercially market the Aortic Connector. Kenton Zehr, MD, assistant professor of cardiac surgery at Mayo, performed the first procedures and subsequently completed three more using both on-pump and off-pump techniques. The device is the first in a line of mechanical connectors and delivery systems St. Jude Medical is developing for the CABG market. The second product in the Symmetry Bypass System, the Coronary Connector, was first implanted in November 2000 and is in clinical evaluation outside the U.S.
Sunrise Technologies (Fremont, California) said that its Hyperion LTK System has had initial success treating astigmatism in preliminary clinical trials in patients outside of the U.S. "The treatment algorithm performed as expected in the trial," said Donald Sanders, MD, PhD, director of the Center of Clinical Research (Elmhurst, Illinois). "The astigmatism reduction was in the proper axis and initial results of the clinical trials are promising. Patients are showing improved vision and no loss of best spectacle corrected visual acuity even at the one-day and two-week postoperative follow-up period." The FDA approved the system for the temporary reduction of hyperopia. The company also is seeking FDA clearance for use of the system for astigmatism. Sunrise is a refractive surgery company developing holmium: YAG laser-based systems.
SuturTek (North Chelmsford, Massachusetts), a privately held medical device company, received FDA 510(k) clearance for its Fast Close device. The company said that the device will eliminate the risk of dangerous and costly suture needle sticks in millions of surgical cases where stapling is not applicable, enabling surgeons to achieve wound closure more quickly, easily and safely than hand suturing. Fascia closure, which is currently accomplished by hand suturing, is the first application planned for the device.
Orhan Tuncay, MD, professor and chairman of the department of orthodontics and division of pediatric dentistry at Temple University School of Dentistry (Philadelphia, Pennsylvania) reports development of a procedure using 3-D graphics and animation to plan a patient's treatment. Tuncay described the procedure as "the first-ever animation of the human face using 3-D, laser-generated images. It's the only such system in the world." Tuncay's procedure, called 3-D CIMAS, or three-dimensional Craniofacial Imaging and Motion Animation System, allows both the patient and clinician to view the proposed orthodontic treatment and the treatment outcome before work begins. Tuncay's 3-D CIMAS uses a Minolta Vivid 3-D Non-Contact Digitizer to scan a face in just 0.6 seconds, capturing both 3-D surface geometry and color texture data for input into a PC or laptop computer. It captures an object's image in 200 x 200 (40,000) range points for surface mapping and in 400 x 400 (160,000) point color texture mapping. The procedure uses Minolta scanning/registration and texture mapping software included with the Vivid digitizer. Once the 3-D images are produced, they are morphed and animated using 3-D Studio Max, a commercial software package used extensively in arts and entertainment.
Tutogen Medical (Clifton, New Jersey) said that Sulzer Dental (formerly Sulzer Calcitek) will introduce Puros, Tutogen's human-derived bone grafting products in France, and Navigraft, Tutogen's bovine bone grafting products in Germany. Tutogen said it plans to seek additional registration for the sale of bovine material in France in conjunction with the launch of Puros. Tutogen uses its patented Tutoplast process of tissue preservation and viral inactivation to manufacture bioimplants for neurosurgical, orthopedic, reconstructive and general surgical indications. Tutoplast-processed tissues have been used for over 25 years in more than 500,000 surgical transplant cases without a single documented case of disease transmission, the company said.
Urologix (Minneapolis, Minnesota) said that 30 patients have been treated under a feasibility study for its new Cooled ThermoCath benign prostatic hyperplasia (BPH) treatment technology. Cooled ThermoCath combines a new design with materials that the company said enhance the cooling of the urethra during treatment. With thermal- or heat-based BPH treatments, preservation of the urethra through cooling is key to achieving an optimal treatment with durable outcomes and the level of patient comfort required for an office treatment. In addition to the patents for the cooling technology that Urologix holds, the company recently was awarded a patent covering the upgrades in the Cooled ThermoCath product platform. Michael Selzer, president and CEO, said, "We are eager to commence a multicenter IDE study, which is anticipated to begin this summer, to demonstrate the advantages of our ThermoCath technology and make it available to the many men who suffer from BPH." Urologix makes minimally invasive medical products for the treatment of urological disorders.
Welch Allyn (Skaneateles Falls, New York), maker of medical diagnostic instruments, released the results of a randomized controlled trial of its blood pressure monitoring service. The study, conducted by the State University of New York Upstate Medical University (Syracuse, New York), recommended that patients with established hypertension who are in the process of evaluation for a change in medication would benefit from the use of this type of home monitoring system, the company said. The Welch Allyn Blood Pressure Monitoring Service is an in-home service that allows for the transmission of blood pressure data over telephone lines. The information is then aggregated and compiled into summary reports that are sent regularly to both physicians and patients. The information is also available at anytime on a secure web site. According to results, over the course of the 11 weeks patients were in the study, "blood pressure decreased in patients who were placed on monitoring service, while hypertension worsened in patients receiving usual care." When comparing the net change in blood pressure between the two groups, the difference was roughly 5 mmHg systolic/4 mmHg diastolic, the study showed. The results of the study were similar, regardless of whether BP was measured by a change in average 24-hour ABPM readings, or by the percentage of BP readings above the target levels.