A Medical Device Daily
CorMatrix Cardiovascular (Marietta, Georgia), which is focused on developing extracellular matrix (ECM Technology) biomaterial devices that harness the body's ability to repair damaged cardiovascular tissue, said it has begun its expansion in Europe following the first use of the CorMatrix ECM Technology in a patient undergoing cardiac surgery.
Following implantation by a surgeon, the CorMatrix ECM Technology acts as a scaffold into which the patient's own cells migrate and integrate, stimulating the body's innate wound-healing mechanisms to repair tissue at the site of implantation.
As the patient's cells populate the matrix, they lay down their own collagen, which matures over time to form a functional tissue repair. The implanted ECM material is gradually replaced and reabsorbed by the body as the patient's tissue is remodeled.
The first procedure in Europe was completed by Stephan Jacobs, MD, and Volkmar Falk, MD, both of University Hospital Zurich in Switzerland, who utilized the CorMatrix ECM Technology to close the pericardium of a 70-year-old patient following triple coronary artery bypass graft surgery.
Jacobs hailed the ease of use of CorMatrix ECM, adding: "This is an advancement in cardiac surgery to restore the patient's normal anatomical structures, which we believe is in the patient's best interest."
"Our European launch further validates the increasing interest and acceptance that our ECM Technology continues to receive among the clinical community," said CorMatrix President/COO Beecher Lewis. "Because our ECM Technology supports native tissue repair, it represents a significant advancement over currently available materials."
The company's chief scientific officer, Robert Matheny, MD, said, "Closure of the pericardium is beneficial as it restores the natural barrier between the heart and the chest wall; it protects the heart, underlying grafts that were applied to the heart, and makes it easier and safer to re-access the heart if a subsequent procedure is required."
Since the launch of the CorMatrix ECM for pericardial closure, the technology has been used at more than 220 hospitals across the U.S. and has been implanted during more than 10,000 cardiac procedures.
CorMatrix Cardiovascular holds an exclusive license from Purdue University (West Lafayette, Indiana) to research, develop, manufacture and market naturally occurring ECM products for cardiovascular applications.
The company currently has U.S. clearance and European CE-mark approval for ECM as an implant for pericardial closure, and clearance in the U.S. for use in cardiac tissue repair.
CE mark for new BioMatrix DES size
Biosensors International Group (Singapore) reported receiving CE-mark approval for a 2.25 mm diameter version of its BioMatrix drug-eluting stent (DES) system, expanding the existing line of 2.50 mm to 4.00 mm stent diameters.
The company said this new addition to the BioMatrix portfolio "offers a major opportunity to increase market penetration, as an estimated 12% to 15% of all percutaneous coronary interventions (PCI) involve blood vessels with diameters of 2.50 mm or less.
BioMatrix was originally launched in Europe in April 2008, where its coating formulation consisting of an abluminal biodegradable polymer and the Biolimus A9 drug has been "very well accepted," according to the company.
The DES system is now available in many international markets outside of China, the U.S. and Japan.
Jeffrey Jump, Biosensors' senior VP for global sales and marketing, said the addition of the 2.25mm stent to the BioMatrix offering "confirms our commitment to provide physicians and patients with our state-of-the-art technology in a wide range of lengths and diameters. "
He said the company expects to launch the new-sized BioMatrix stent during the next several months.
FlexStent biliary stent approved
Flexible Stenting Solutions (FSS; Eatontown, New Jersey), a developer of next-generation flexible stents, said it has received CE-mark approval for its FlexStent biliary self-expanding stent system.
Available sizes include 5 mm, 6 mm, 7 mm and 8 mm diameters, with 30 mm through 120 mm lengths in a 6 Fr delivery system.
The FlexStent Biliary Stent System is indicated for the treatment of biliary strictures resulting from malignant neoplasms. FSS said the key to its stent technology is the integration of helically wound struts with helical flexible coils. The key to the delivery technology is simplicity, ease of use and placement.
In addition to the CE mark, FSS has submitted 510(k) notification to the FDA and is awaiting U.S. clearance for the system.
Norwegian firm adds Enterix test
ScreenCancer (Oslo, Norway), a company offering cancer screening management services to employers, insurance companies and individuals, said that it has added the InSure FIT take-at-home colorectal cancer screening test to its European Cancer Screening Program.
Screen Cancer's two-year distribution agreement with Enterix, a subsidiary of diagnostic testing company Quest Diagnostics (Madison, New Jersey), grants ScreenCancer limited exclusive rights to offer InSure FIT in 24 countries of the European Economic Union.
Colon cancer is the second-most-common form of cancer in Europe. Despite considerable progress in treatment, the mortality rate in Europe has remained high and it has been concluded that it can only be reduced through an intensive campaign of prevention and screening, ScreenCancer said.
InSure FIT features a long-handled brush to collect two water-based samples, rather than the solid samples required by other FITs (fecal immunochemical tests) or FOBTs (fecal occult blood tests), and does not require any change in patient diet or medication.