BETHLEHEM, Pa., April 19, 2018 (GLOBE NEWSWIRE) -- B. Braun Interventional Systems Inc. (BIS) in collaboration with NuMED Inc., announced today the Food and Drug Administration pre-market approval and U.S. commercial launch of an expanded size offering and new indication for the Cheatham-Platinum (CP) Stent portfolio.
The CP Stent became available in the U.S. market in 2016 for treatment of coarctation of the aorta with BIS entering into an exclusive U.S. distribution agreement with the manufacturer, NuMED Inc. Building upon the success of the CP Stent in the market, and in an effort to address unmet clinical needs, additional sizes and indications have been pursued.
The newly approved indication applies to the Covered and Covered Mounted CP Stent™ configurations for the treatment of right ventricle to pulmonary artery (right ventricular outflow tract, RVOT) conduit disruptions. These disruptions are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR). The pivotal trial associated with this approval, PARCS (Pulmonary Artery Repair with Covered Stents), is publicly available on the ClinicalTrials.gov site for more details.
In addition to the new indication, this latest approval also includes additional sizes for the CP Stent portfolio. The expanded size offering includes CP Stent configurations expandable up to 30 mm in diameter and lengths up to 6 cm. All sizes and configurations of the Covered CP Stent are now approved for the treatment of both coarctation of the aorta and RVOT conduit disruptions, while the bare CP Stent configurations are only approved for the treatment of coarctation of the aorta.
“Over the first two years of U.S. commercial availability, the CP Stent has demonstrated an impressive record of clinical utility in some of the most challenging interventional cases. The recent portfolio expansion for larger diameters, longer lengths, and a new indication are significant developments for this critical product line,” said Peter Flosdorf, B. Braun Interventional Systems Engineering Manager. “We are proud to collaborate with NuMED to provide physicians with indispensable tools for the treatment of congenital heart defects.”
"The approval of the additional sizes and clinical applications for the CP Stent line is an exciting milestone for NuMED that further delivers on our commitment to improve patient care by bringing to market innovative solutions to unmet clinical needs within the structural heart community," said Al Tower, President of NuMED, Inc. “We are pleased to continue our longstanding collaboration with the B. Braun Interventional Systems team to help us support the U.S. market for congenital heart interventions."
About B. Braun Interventional Systems
B. Braun Interventional Systems offers interventional solutions designed with the patient in mind. Many of the products offered have been developed in response to the needs of physicians, technicians, and nurses. The company is committed to delivering safety, precision and convenience to interventional procedures. B. Braun Interventional Systems Inc. is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Medical Inc., Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Interventional Systems Inc., visit www.bisusa.org/about-us.
About NuMED, Inc.
Since 1982, NuMED has been developing, manufacturing and delivering innovative cardiovascular medical products for the smallest of patients to adults with heart defects.
Headquartered in Hopkinton, NY, NuMED’s mission is to improve the quality of patient care and the productivity of health care by developing and advocating less-invasive medical devices and procedures. They are committed to continually refining their existing products, and researching new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare. To learn more about NuMED, visit www.numedforchildren.com.
Contact:
Jason Ford
B. Braun Medical Inc.
610.997.4722
jason.ford@bbraunusa.com