Medtronic AVE (Santa Rosa, California), a division of Medtronic (Minneapolis, Minnesota), has received CE-mark approval for its INX Neurovascular Stent. The company said that it is the only stent available on the market for use in the brain, with clearance given for the specifically intracranial, wide neck aneurysms. The INX provides an alternative treatment for patients who are considered high risk for surgery. The company says that the device is especially useful in cases where embolic coils might migrate into a blood vessel and cause a stroke. Approximately 80,000 people worldwide develop brain aneurysms, a weakening of blood vessels that compress parts of the brain. If left untreated, this condition can lead to debilitating conditions, such as strokes and even death.

Michael Williams, vice president and general manager of the Neurovascular Technologies Division at Medtronic AVE, said, "The difference between this neurovascular stent and other stents lies in the remarkable amount of flexibility that the INX possesses." Williams told The BBI Newsletter that this high degree of flexibility allows the device to be more easily threaded through the arteries of the head and neck, which have thinner walls than other arteries. Williams said that the INX is delivered, much like a coronary stent, through the groin at the femoral artery. A balloon attached at the end of the stent is then deployed at the target area to "trap" the aneurysm and cut off the supply of blood to the affected area. Due to the sensitivity of the arteries, the balloon used is also of a lower pressure.

The time of the procedure can vary from "15 minutes to several hours, depending on the complexity and fragility of the affected area," Williams said. The stent comes in 6 mm, 8 mm, 10 mm, 12 mm and 18 mm sizes, with prices ranging from $1,500 to $2,500. He said that he expects U.S. approval by the end of 2001. "Since this is a new device, FDA will probably put it through more rigorous testing." The stent was tested at seven clinical sights throughout the world prior to its CE mark. The company also is looking at other applications for the INX stent. Studies are under way in Europe and the U.S. to use the INX for the treatment of intracranial, atherosclerotic lesions.

Elsewhere in the product pipeline:

Aventis Behring (King of Prussia, Pennsylvania) said results of its pivotal Phase I trial for Recombumin 20% showed the overall incidence of adverse events was low and no dose-related increase in adverse events could be detected. The trial was designed to assess the tolerability of the recombinant human albumin as a stabilizing component in pharmaceutical and biological products, such as vaccines, recombinant therapies and coatings for medical devices.

Berlex Laboratories (Montville, New Jersey) and DUSA Pharmaceuticals (Wilmington, Massachusetts) reported FDA clearance of the BLU-U Blue Light Photodynamic Therapy Illuminator, used in the Levulan Photodynamic Therapy (PDT) System for treatment of non-hyperkeratotic actinic keratoses (AKs) of the face or scalp. The Levulan PDT System is the first to use light activated drugs to treat these common skin lesions, the company said. The active ingredient in the Levulan PDT System is aminolevulinic acid, delivered in a solution applied to the lesion. When the solution reacts to visible blue light, the lesion is destroyed. In clinical trials, the Levulan PDT System achieved clearing of all AK lesions with one treatment in more than 70% of patients at 12 weeks. AKs appear on the skin as scaly, discolored patches. According to the companies, actinic keratoses are the third most frequent reason for visiting a dermatologist. Berlex obtained exclusive worldwide marketing and distribution rights, excluding Canada for the Levulan PDT System for dermatology indications from DUSA Pharmaceuticals.

Biosyntech (Laval, Quebec, Canada) said it has successfully completed preclinical safety and evaluation studies of one of its lead products, BST-GEL, an injectable, thermo-sensitive hydrogel. According to the company, the studies showed the product has no systemic toxic effects at dose levels up to 100 times greater than would be used in clinical therapy. The preclinical acute and sub-chronic repeat-dose subcutaneous animal toxicology trials were performed at ITR Laboratories Canada. The company also said that BST-GEL was found to localize as a deposit at the site of administration by injection, without causing any inflammatory response or other indications of systemic effects, such as overt clinical signs, mortality and loss of appetite or body weight. The investigations in sub-chronic studies showed no significant changes in the organ weights, and gross pathology findings were limited to localized deposits of BST-GEL at injection sites without evidence of encapsulation or other adverse biological response. Biosyntech specializes in tissue engineering, the delivery of advanced injectable biomaterials and biotherapeutic agents.

Boston Probes (Bedford, Massachusetts) received a U.S. patent for an application of Peptide Nucleic Acid (PNA) probe technology covering broadly claimed methods resulting in what the company says is a substantial reduction in the non-specific signal in the assay as compared with conventional nucleic acid probe-based hybridization assays. The technique thereby improves the performance of the probe-based assays far beyond that obtained by mere optimization of stringency conditions. PNA probe based methods are useful for single nucleotide polymorphism analysis. Thus, the patented methods can be applied to the development and commercialization of products in several areas, including basic research, genomics, forensic analysis, pharmaceutical discovery and food and environmental testing. Boston Probes' PNA probe technologies are used in agriculture, human and veterinary diagnostics, as well as in the detection of microorganisms in foods, beverages, water, the environment and industrial processes such as pharmaceutical manufacturing.

Cardima (Fremont, California) reported receiving its 25th patent for an intravascular device for occluding blood vessels in patients by using radiofrequency energy emitted from a device within the blood vessel. Gabriel Vegh, president and chief executive officer of Cardima, said, "There may be applications in the head, other vital organs or in the peripheral vasculature where it may be desirable to seal off vessels to stop a leaking vessel or completely stop blood flow to a part of the body to starve the blood supply, for instance, to a tumor."

CardioTech International (Woburn, Massachusetts) has been issued U.S. patent, No. 6,117,535, covering a unique method of reinforcing vascular grafts with polyurethane monofilaments that result in compliant, elastic and torque-resistant grafts. The invention is based on the properties of ChronoFlex biodurablepolycarbonate-based polyurethane elastomers. ChronoFlex filaments are inherently elastic, thus producing elastic small-bore vascular grafts, compared to standard ePTFE grafts that are stiff and non-compliant. The filaments, 250 microns in diameter, are automatically applied to the outer surface of pre-formed microporous vascular grafts by a precision machine that applies a mist of solvent onto the monofilaments making them temporarily adhesive. Once adhered, the monofilaments can remain permanently attached or may be manually removed during use without damaging the structural integrity of the microporous graft.

CBYON (Washington) introduced what it termed "the world's first set of surgical anatomy visualization and navigation tools," the SAVANT Suite, at the American Academy of Otolaryngology annual meeting. The system features anatomical positioning and 3-D visualization. Computerized tomography and MRI are used to build a virtual 3-D model of the patient anatomy prior to surgery, with a semi-transparent computer rendering displayed from the perspective of the scalpel. Ramin Shahidi, PhD, director of the Image Guided Laboratories at Stanford University (Stanford, California), where CBYON's technology was prototyped, said that SAVANT "enables surgeons to visualize the patient's internal anatomy without the need for large incisions. It is now possible to 'fly through' the virtual inside of the actual patient and localize structures of clinical relevance."

The Chase Medical (Richardson, Texas) epRetract II Epicardial Retracting Stabilizer was previewed during the Cardiac Surgical Patient in the 21st Century OPCAB/PADCAB Course held recently at Emory University School of Medicine (Atlanta, Georgia). Surgeons were proctored in an animal lab training session conducted by Robert Guyton, MD, chief of Emory's department of cardiothoracic surgery. Guyton later used the Chase Medical Stabilizer in an actual surgical case, performing several graft anastamoses for a closed-circuit audience. Chase, along with several other companies involved in the manufacture of beating-heart surgical devices, sponsored the training session with Emory University.

Cordis Neurovascular (CNV; Miami, Florida), a unit of Johnson & Johnson company Cordis, has received FDA clearance for the Trufill n-BCA Liquid Embolic System for presurgical embolization of cerebral arteriovenous malformations (AVMs), which are tangles of abnormally connecting arteries and veins. The product is an artificial embolization device comprised of Trufill n-Butyl Cyanoacrylate (n-BCA), Trufill Ethiodized Oil and Trufill Tantalum Powder which are combined into a mixture that is injected through a microcatheter to embolize AVMs prior to surgical resection. AVMs occur in less than 1% of the population but come with the risk of severe neurologic deficit or death if untreated. The product will be available soon and will be "compatible with Cordis Neurovascular delivery catheters, including our Reatta Flow Guided Infusion Catheter, as well as our Prowler, and Transit microcatheters," the company said.

ESC Medical Systems (Yokneam, Israel) has introduced the AcuBlade laser system, a laser providing robotic capabilities for microsurgery. The company said this new generation in laser systems combines a computerized laser scanning system with an operating microscope to enable physicians to provide highly uniform incisions with reduced operating time and improved precision and safety. Marc Remacle, a larynx specialist and professor of medicine at Mont Godinne Hospital (Yvoir, Belgium), presented the results of clinical studies conducted with AcuBlade at the meeting of the American Academy of Otolaryngology. He said, "AcuBlade represents a leap forward in the treatment of vocal cord diseases, including nodules, polyps and cysts. The precise linear incision capabilities and shaped cutting introduced with AcuBlade enable us to successfully treat these ailments without injuring the vocal ligaments, which cause major changes in a person's voice." ESC President and CEO Yacha Sutton said the company expects to apply robotic microsurgery technology to other applications, including aesthetic surgery.

Medical robotics company Computer Motion (Santa Barbara, California) said that its new FDA clearance strategy for the ZEUS Robotic Surgical System will be to pursue parallel 510(k) approvals in both general laparoscopic and cardiac surgery. The company has several clinical studies under way or awaiting Investigational Device Exemption (IDE) approval across five major surgical fields: coronary artery bypass surgery, thoracoscopic surgery, cardiovascular surgery, general laparoscopic surgery and gynecologic surgery. In January, Computer Motion completed a ZEUS System feasibility study for coronary artery bypass grafting (CABG) on 32 patients at three U.S. cardiac centers, calling it the first U.S. study of its kind. The FDA has now approved a multicenter, randomized, controlled CABG trial at 12 ZEUS sites. According to the company, this is the only FDA-approved multicenter robotic cardiac study in the country. Computer Motion anticipates filing a 510(k) submission in 2Q01 and approval in 3Q01. It expects to submit a 510(k) application for non-intracardiac thoracoscopic clearance in 1Q01, following the completion of the clinical trial.

Draxis Health (Mississauga, Ontario, Canada) said that Draxis' wholly owned radiopharmaceutical subsidiary, Draximage (Kirkland, Ontario, Canada), has received U.S. Nuclear Regulatory Commission approval for its BrachySeed implant for prostate cancer therapy. The company expects that BrachySeed will be available later this year through Cytogen (Princeton, New Jersey), its U.S. partner. The product is a second-generation brachytherapy implant that Draximage said demonstrates "a number of important innovations over currently available technology, including double encapsulation for additional patient safety and near perfect dosimetry." Brachytherapy implants are used in the treatment of localized cancers, primarily prostate. Cytogen is a biopharmaceutical company. Draximage makes radiopharmaceuticals.

MedSearch Technologies (New York) is developing a wireless versatile platform technology for home care expected to be applied in monitoring patients in their homes and in their everyday environment using Personal Data Assistants (PDAs). MedSearch's software and hardware application is expected to be compatible with most standard PDAs. The company said this system is the first to use PDAs as patient monitors by using disposable sensors. The data acquired in the PDA is stored, displayed if necessary and transferred via wireless channels to a central secured server. It then can be analyzed online and accessed by authorized personnel using either a desktop computer in the clinic or another PDA. The company's various home care applications for the technology are at different stages of development.

Medtronic's (Minneapolis, Minnesota) R1 Rapid Exchange Balloon Dilatation Catheter with Perfusion Technology has received FDA clearance. Medtronic said introduction of the R1 balloon catheter completes the AVE product line and provides interventional cardiologists with a choice of both over-the-wire and rapid exchange balloon dilatation catheters. The R1 rapid exchange balloon catheter family is available in lengths of 10 mm, 16 mm, 20 mm and 30 mm and in diameters from 1.5 mm to 4 mm. The entire R1 family offers perfusion capabilities at an average rate of 2cc/minute at nominal pressure.

Molecular Devices (Sunnyvale, California) introduced its third reagent kit, the FLIPR Membrane Potential Assay Kit, for high-throughput screening. The kit makes high throughput assays for the study of ion channels a reality, greatly expanding the functionality of the company's FLIPR system, according to Molecular Devices. The kit provides all the reagents needed for the screening of ion channels, an important class of drug targets, with the reagents in the kit having a much faster response time than the traditional protocol, according to the company, reducing total assay time for a 384-well plate from about 20 minutes to under two minutes. Molecular Devices now offers two kits that enable two assays for drug discovery to be performed on the FLIPR system, designed for screening G-protein coupled receptors.

QRS Diagnostic (Plymouth, Minnesota) has introduced EKGCard, which the company says is the smallest and lightest electrocardiograph device available on the market. EKGCard inserts into a computer to record and analyze up to 12-channels of high-resolution EKG data. EKGCard is compatible with laptop and desktop computers and offers a complete narrative interpretation package. EKGCard has received FDA 510(k) clearance, and QRS terms it "ideal for physician offices and alternate health care sites that desire portability and lower cost medical equipment." QRS is a privately held company that makes diagnostic and monitoring medical devices for health care providers and chronic disease management in the home.

Vasca (Tewksbury, Massachusetts) has been granted FDA 510(k) clearance for the LifeSite Hemodialysis Access System, the application processed via the agency's expedited review guidelines. The LifeSite device is implanted subcutaneously and accessed via the "buttonhole" technique by inserting a standard dialysis needle. The LifeSite System is designed to provide high flow rates, reduce the risk of infection, is unobtrusive and can be used immediately following implantation since it requires no maturation time. The LifeSite System has received CE-mark clearance for both hemodialysis and peritoneal dialysis, and clearance in Canada for hemodialysis. LifeSite also is eligible for transitional pass-through payment under Medicare's new Ambulatory Payment Classification system.

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