BrosMed’s POT NC PTCA Balloon Dilatation Catheter Cleared by FDA

April 12, 2023—BrosMed Medical, a medical device company based in Guangdong, China, announced FDA 510(k) clearance for its dedicated noncompliant (NC) percutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter for the proximal optimization technique (POT) and distal optimization technique (DOT) in bifurcation stenting.

BrosMed’s POT NC PTCA catheter, which provides a precise tool for percutaneous coronary intervention to treat bifurcation lesions, is now commercially available in the United States. It has been available in Europe.

The company stated that its POT NC PTCA device is designed especially for POT and DOT procedures. It features extra short balloon shoulders and precise apposition performance to reduce longitudinal balloon growth and minimize the potential for vessel trauma outside the treatment area in bifurcation stenting.

According to the company, the POT approach has been proposed as an effective strategy to achieve optimal stent expansion and apposition in the proximal segment in coronary bifurcation. In the technique, a short, appropriately sized balloon—like BrosMed’s POT NC PTCA device—is inflated in the main vessel just proximal to the carina. The company noted that this technique reduces the risk of side branch compromise related to shifting of the carina, improves stent apposition in the proximal main vessel, and facilitates side branch access after main vessel stent implantation.

Professor Shao-Liang Chen, MD, developer of the double-kissing crush stenting technique, commented in the company’s press release, “A real POT balloon innovated by BrosMed has provided the final solution for either POT or DOT. POT PTCA balloon catheter offers tremendous promise and adds a state-of-the-art coronary balloon to BrosMed’s leading products portfolio.”