Medical Device Daily
Following the launch of micro-stenting of peripheral vessels of less than 2 mm, Invatec (Leipzig, Germany) has launched in Europe a novel drug-eluting balloon to treat atherosclerosis in arteries located below the knee.
Designed for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, the balloon catheter technique was introduced as a world first at the recent Leipzig Interventional Course.
The Invatec IN.PACT Amphirion is a paclitaxel-eluting balloon that features FreePac, a proprietary coating that frees and separates paclitaxel molecules to facilitate absorption into the wall of the artery.
The THUNDER trial, published in February 2008 in the New England Journal of Medicine, found paclitaxel-coated angioplasty balloons effective during percutaneous treatment of femoropopliteal disease reporting significant reductions in late lumen loss and target-lesion revascularization.
Yet the authors noted that with inflation of the balloon less than 20% of the paclitaxel is absorbed in the artery walls.
Invatec declined to describe the FreePac formulation that enhances absorption of the therapeutic, telling Medical Device Daily that it was developed in close collaboration with the researchers who pioneered drug-eluting balloon therapy at Charité Berlin and the University Hospital of Saarland (Homburg, Germany).
Ulrich Speck, PhD, at Charite and Dr. Bruno Scheller at Saarland are co-inventors of several methods for inhibiting restenosis, including techniques used in the THUNDER trial.
The co-founders of Invatec, Andrea Venturelli and Stefan Widensohler, said they are building on a platform of technology targeted specifically for below the knee interventions that includes the company's Amphirion DEEP balloon catheter, the Skipper DEEP guide wire, the Chromis DEEP balloon-expandable stent and the Maris DEEP self-expandable stent, which was introduced at EuroPCR in Barcelona in May 2008.
They said Invatec plans to launch a randomized trial, the IN.PACT DEEP study, in the first half of 2009, to provide additional data about the effectiveness of this new treatment concept.
The drug-eluting balloon concept has the potential to reduce re-intervention rates for patients with atherosclerosis and will allow for the development of specific solutions for additional endovascular applications including the superficial femoral artery (SFA), they jointly stated.
Impaired blood flow caused by blockages below the knee, also known as critical limb ischemia (CLI) result in pain, poor wound healing, gangrene and a high risk of death.
According to data published in Wounds, 40% of patients require amputation within 12 months of a CLI episode, and there is an annual mortality rate of more than 20%.
Invatec opened operations for the U.S. in Bethlehem, Pennsylvania late in 2008 (Medical Device Daily, Sept. 30, 2008).
Bioresorbable implant gets CE mark
Orthomimetics (Cambridge, UK) reported the CE mark approval of Chondromimetic, part of its line of bioresorbable implants for bone and/or soft tissue repair in the EU. The product line was developed during a collaboration between the University of Cambridge and the Massachusetts Institute of Technology (Cambridge, Massachusetts).
Chondromimetic is an off-the-shelf implant that helps to support the repair of defects involving both articular cartilage and bone, defects that can result from sports injuries, surgical intervention and other trauma.
The company noted that articular cartilage damage and subsequent degeneration of the underlying bone are known to be a major cause of arthritis in young individuals.
CE-mark approval enables the company to market Chondromimetic in Europe, and comes earlier than expected.
Orthomimetics said it will immediately launch a comprehensive post-market clinical-trial program for Chondromimetic, and added that it is negotiating distribution agreements for key European territories.
The company will pursue additional approvals in other global territories throughout 2009.
CEO Dr. Andrew Lynn said, "Orthomimetics is extremely pleased to be able to make Chondromimetic available for surgeons and patients in Europe. This approval is the result of a tremendous amount of hard work on the part of our surgeon advisors, scientific collaborators, and – most of all – our professional, dedicated team."
U.S. distributor named for Watchaler
Activaero (Gemü nden, Germany) said that US Pharmaceutical (Decatur, Georgia) will exclusively distribute the Watchhaler, which it calls "a revolutionary inhalation concept for children," in the U.S.
Watchhaler is a reservoir system, or "spacer," controlling the inhalation flow rate and volume to target the aerosol specifically to the lung region, where the drug is needed.
The company said this system is particularly tailored to the needs of children using asthma medications. The Watchhaler spacer is designed for use with standard metered dose inhalers.
Dr. Gerhard Scheuch, founder/CEO of Activaero, said, "The Watchhaler device has been available in Europe for several months now and we are delighted to have reached this agreement with US Pharmaceutical Corporation. We believe that the Watchhaler will benefit both parents and children by providing reliable doses of asthmatic medication in a controlled and accurate manner."
The Watchhaler was originally launched in Europe in April of last year and the FDA issued a 510(K) clearance for the Watchhaler spacer in July 2008.