B. Braun Interventional Systems extends distribution agreement with NuMED.
B. Braun Interventional Systems Inc. (BIS) will be the exclusive U.S. distributor of the NuMED Cheatham Platinum (CP) Stent, which is designed to help treat patients with native and/or recurrent coarctation of the aorta, a severe congenital heart defect.
Hopkinton, N.Y.-based NuMED Inc. received U.S. Food and Drug Administration (FDA) clearance for the CP stent product on March 25. The official U.S. commercial launch took place in early May in Orlando, Fla. BIS is currently the exclusive U.S. distributor of the NuMED PTA, PTV, and BAV balloon catheters.
"We are very pleased to be in a position to build upon our longstanding collaboration with NuMED by adding this clinically relevant portfolio to our exclusive distribution agreement," said Dave Mittl, corporate director of New Business Development at B. Braun Interventional Systems." The CP Stent complements our core portfolio of interventional solutions that are designed to enhance clinical capabilities and improve patient outcomes. Through our collaborative efforts, we remain focused on our work supporting research and development to deliver products that improve the management of congenital heart defects. We are excited to have the opportunity to extend our alliance with NuMED, who continues to deliver impactful product innovations to our industry."
The CP Stent is used for transcatheter stent therapy for treatment of coarctation of the aorta (CoA), a narrowing of the aorta. Most CoA is diagnosed in infancy and childhood. According to the Centers for Disease Control and Prevention, an estimated four out of 10,000 babies are born each year in the United States with coarcation of the aorta. The CP Stent is offered in multiple options: bare, covered, and mounted configurations. The pivotal trials, COAST (Coarctation of the Aorta Stent Trial), and COAST II, sponsored by Richard Ringel of Johns Hopkins University, are available publicly.
"We are very pleased to be able to provide physicians an alternative option to surgical therapy," said Allen Tower Jr., president of NuMED Inc. "After many years of clinical trials and great effort on behalf of everyone at NuMED, we are thrilled to receive the FDA clearance for the CP Stent. Our collaboration with the B. Braun Interventional Systems team in the U.S. helps strengthen our commitment to delivering quality products and improving the lives of patients. We couldn't have picked a better organization to help us deliver the CP stent to the patients, especially the children who have needed this for so long."
B. Braun Interventional Systems is part of the B. Braun Group of companies in the United States, which is headquartered in Bethlehem, Pa., and includes B. Braun Medical Inc., Aesculap, and CAPS. Globally, the B. Braun Group employs more than 55,000 employees in more than 60 countries.
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|Title Annotation:||Industry News|
|Publication:||Medical Product Outsourcing|
|Date:||Jun 1, 2016|
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