Rare Cardiovascular Treatment Readied For Global Market: Proprietary Paccocath R Technology Is The Only Narcotic Eluting Balloon With Clinical Data
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MEDRAD Interventional(TM)/Possis(R) announced that it has reached fundamental milestones in bringing the Paccocath(R) 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 contain the selection of doctor 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 annex regional 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 interval show that using the Paccocath technology during an angioplasty procedure keeps the vessels open wider over day compared to criterion angioplasty and published reports (1) of other current standard-of-care therapies.
Cotavance(TM) is the trade-mark epithet of the drug-eluting balloon angioplasty catheter that is currently being developed by MEDRAD Interventional(TM)/Possis(R) 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, Fashionable York) and Gary Ansel, M.D. of Riverside Methodist Infirmary (Columbus, Ohio) have been selected as the co-primary investigators for the U.S. clinical peripheral pivotal trials to adjust FDA approval for Cotavance. "The safety and efficacy outcome of the THUNDER announce from Europe is a fine starting objective for US clinical trials with the Cotavance product. I am very hopeful that this technology will provide dewy and higher quality treatment options for patients with claudication," said Dr. Gray.
"Paccocath is in the solo position of being the only drug eluting balloon technology with skilled clinical science results. The THUNDER and FEM studies, which used the Paccocath technology exclusively, expo its potential efficacy and safety in peripheral applications," said Professor Gunnar Tepe, MD, of Klinikum Rosenheim in Rosenheim, Germany. The happy clinical results to age achieved nailed down the application of the Paccocath technology obtain encouraged others to marketplace coated balloons, nevertheless without the Paccocath technology, none have proven clinical science benefits. According to Dr. Ansel, "The abstraction of drug eluting balloons is perfect attractive, on the other hand there may be yet amassed to creating a clinical event than honorable putting a drug onto an angioplasty balloon. What appears to adjust this technology lone is the appendix of the Ultravist(R) to the Paclitaxel, which seems to allow for forceful drug uptake in the treated vessel."
Bayer Schering Pharma AG (Berlin, Germany) is the owner of the Paccocath technology and is developing it for bazaar fini Bayer affiliate, MEDRAD, Inc. Kraig McEwen, senior vice head of the state 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 aid us understand patient outcomes in a variety of treatment situations. The Paccocath technology continues to be the most studied and first-class understood and we credit that such careful characterization is important to assure patient safety and improved outcomes."
Another major milestone in bringing Paccocath technology to market has been the completion of a balloon coating Centre of Excellence facility in Minneapolis, Minnesota, which is the primary mark for balloon coating and the development of fated coating technologies and drug formulations. "Our investments in Paccocath technology proof and in the manner of the Cotavance product display 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 passion disease, B.Braun Melsungen AG (Berlin, Germany) has licensed the technology for use in its SeQuent(R) 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 benefit of the Paccocath technology, B. Braun conducted the PEPCAD clinical studies, which if evidence in support of its utilize in coronary arteries.
About MEDRAD Interventional/Possis
Possis Medical, a colonizer in the field of thrombus removal, has recently merged with MEDRAD, the leader in diagnostic and interventional contrast injection. Together, they compass formed MEDRAD Interventional / Possis, a division of MEDRAD, INC., focused on advancing interventional medicine through research and innovation. With manufacturing facilities in both Minneapolis, MN and Pittsburgh, PA, MEDRAD Interventional / Possis manufactures and markets segment-leading medical devices such as AngioJet(R) Thrombectomy Systems, MEDRAD Avanta(R) Fluid Government Injector Systems, Point V ProVis(R) Angiographic Contrast Injectors, the GuardDOG (R) Occlusion System, FETCH(R) Aspiration Catheters and the SafeSeal(R) Hemostasis Patch.
About MEDRAD, INC.
MEDRAD, INC. develops, markets and services medical devices used to diagnose and treat disease. Its product offerings include fluid injection systems for radiology and cardiology, endovascular devices for the guarded treatment of cardiovascular disease, attractive resonance-compatible accessories and equipment services. MEDRAD's total 2008 revenues were over $600 million. The company's environment headquarters is near Pittsburgh, Pennsylvania, in the United States. MEDRAD is a business of Bayer Medical Care.
The Bayer Chain is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products production and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the autonym Bayer Schering Pharma. Bayer HealthCare's point is to determine and manufacture products that testament amend human and animal health worldwide.
Cautionary statement regarding forward-looking statements
Persuaded statements in this press proceeds that are neither reported financial results nor other historical information are forward-looking statements, including however not district to, statements that are predictions of or exhibit looked toward events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to proclaimed and incog risks and uncertainties and can be affected by other factors that could agency actual results and Bayer's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Bayer undertakes no debt to renovate publicly or revise any of these forward-looking statements, whether to reflect dissimilar information or impending events or circumstances or otherwise.
(1) Duda SH, Bosiers M, Lamme J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and naked nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006; 13: 701-710.
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