B. Braun Interventional Systems said today it extended its exclusive U.S. distribution deal with NuMed for to include its newly-cleared Cheatham Platinum stent designed to treat native or recurrent coarctation of the aorta.
The CP stent won FDA 510(k) clearance in March, and the commercial launch in the U.S. is scheduled to take place this week, Bethlehem, Penn.-based B. Braun said.
“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. The innovative 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,” B. Braun new biz dev Dave Mittl said in a prepared release.
The CP stent is designed for use during transcatheter stent therapy for treating narrowing of the aorta, which is generally diagnosed in infancy and childhood, the company said. An estimated 4 of 10,000 babies are born with coarction fo the aorta, according to the Centers for Disease Control and Prevention.
“We are very pleased to be able to provide physicians an alternative option to surgical therapy. 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,” NuMed prez Allen Tower Jr. said in a press release.
The stent will be offered in bare, covered and mounted configurations, B. Braun said.