MEDRAD Interventional/Possis® announced that it has reached key milestones in bringing the Paccocath® Technology closer to market as an option for the over 14 million patients in the United States and Europe who suffer from Peripheral Arterial Disease (PAD). These milestones include the selection of physician investigators for U.S. clinical trials and the completion of a new state-of-the-art manufacturing facility.
In routine treatment of stenotic or occluded vessels, doctors widen the narrowed vessel using an angioplasty balloon catheter. In some cases, a stent, which is a metal scaffold, is then placed to hold the vessel open. However, these treatments may have limited effectiveness since, for most patients, the vessels often re-occlude within a year after treatment.
The Paccocath technology is a proprietary drug matrix applied to the balloon of an angioplasty catheter. When the catheter is inflated to dilate the narrowed vessel, an anti-restenotic drug is released directly to the diseased area. Clinical results to date show that using the Paccocath technology during an angioplasty procedure keeps the vessels open wider over time compared to standard angioplasty and published reports (1) of other current standard-of-care therapies.
Cotavance is the brand name of the drug-eluting balloon angioplasty catheter that is currently being developed by MEDRAD Interventional/Possis® that utilizes the Paccocath technology. MEDRAD is in the process of obtaining CE Mark certification and seeking FDA approval for its Cotavance product. William Gray, M.D. of Columbia University (New York, New York) and Gary Ansel, M.D. of Riverside Methodist Hospital (Columbus, Ohio) have been selected as the co-primary investigators for the U.S. clinical peripheral pivotal trials to achieve FDA approval for Cotavance. “The safety and efficacy outcome of the THUNDER study from Europe is a great starting point for US clinical trials with the Cotavance product. I am very hopeful that this technology will provide new and better treatment options for patients with claudication,” said Dr. Gray.
“Paccocath is in the unique position of being the only drug eluting balloon technology with positive clinical science results. The THUNDER and FEM studies, which used the Paccocath technology exclusively, show its potential efficacy and safety in peripheral applications,” said Professor Gunnar Tepe, MD, of Klinikum Rosenheim in Rosenheim, Germany. The successful clinical results to date achieved through the application of the Paccocath technology have encouraged others to market coated balloons, but without the Paccocath technology, none have proven clinical science benefits. According to Dr. Ansel, “The concept of drug eluting balloons is very attractive, but there may be much more to creating a clinical effect than just putting a drug onto an angioplasty balloon. What appears to make this technology unique is the addition of the Ultravist® to the Paclitaxel, which seems to allow for significant drug uptake in the treated vessel.”
Bayer Schering Pharma AG (Berlin, Germany) is the owner of the Paccocath technology and is developing it for market through Bayer affiliate, MEDRAD, Inc. Kraig McEwen, senior vice president of MEDRAD Interventional/Possis said, “We are working to further the scientific evidence of the Paccocath technology with additional clinical studies in the U.S. and Europe. These studies are focused on achieving FDA clearance for peripheral indications and will help us understand patient outcomes in a variety of treatment situations. The Paccocath technology continues to be the most studied and best understood and we believe that such careful characterization is important to ensure patient safety and improved outcomes.”
Another major milestone in bringing Paccocath technology to market has been the completion of a balloon coating Center of Excellence facility in Minneapolis, Minnesota, which is the primary site for balloon coating and the development of future coating technologies and drug formulations. “Our investments in Paccocath technology research and in the development of the Cotavance product demonstrate our commitment to drug-eluting balloon technology and our intent to bring the best therapy to market,” said McEwen.
Expanding the Paccocath technology to patients with heart disease, B.Braun Melsungen AG (Berlin, Germany) has licensed the technology for use in its SeQuent® Please drug eluting balloon catheter, which recently received CE certification for the treatment of narrowing of the coronary arteries. Adding to the clinical evidence in support of the Paccocath technology, B. Braun conducted the PEPCAD clinical studies, which provided evidence in support of its use in coronary arteries.