BrosMed’s POT™ NC PTCA Balloon Dilatation Catheter Received FDA 510(k) Clearance
Release time:
2023-04-12
April 12, 2023 — BrosMed Medical announced that it has received FDA 510(k) clearance for the POT™ NC PTCA Balloon Dilatation Catheter, the world’s first dedicated balloon designed for the proximal optimization technique (POT) and distal optimization technique (DOT) in bifurcation stenting.
April 12, 2023 — BrosMed Medical announced that it has received FDA 510(k) clearance for the POT™ NC PTCA Balloon Dilatation Catheter, the world’s first dedicated balloon designed for the proximal optimization technique (POT) and distal optimization technique (DOT) in bifurcation stenting. With this clearance, a specialized tool for precise PCI treatment of bifurcation lesions is now available to physicians in the United States.
Coronary bifurcation lesions account for approximately 15–20% of all percutaneous coronary interventions (PCI) and remain among the most challenging lesion subsets in interventional cardiology, due to procedural complexity and the risk of long-term adverse cardiac events.
The proximal optimization technique (POT) has been proposed as an effective strategy to achieve optimal stent expansion and apposition in the proximal segment of coronary bifurcation lesions. It is a straightforward technique in which a short, appropriately sized balloon, such as POT™, is inflated in the main vessel just proximal to the carina. The advantages of this technique include reducing the risk of side branch compromise associated with carina shift, improving stent apposition in the proximal main vessel, and facilitating side branch access after main vessel stent implantation.
Specially designed for POT and DOT techniques, POT™ provides a dedicated solution for bifurcation stenting procedures. The POT™ NC PTCA Balloon Dilatation Catheter is a non-compliant balloon featuring extra-short balloon shoulders and precise apposition performance, which are intended to reduce longitudinal balloon growth and minimize the potential risk of vessel trauma outside the treatment area during bifurcation stenting.
Prof. Shao-Liang Chen, the inventor of the DK-crush technique, commented, “A true POT™ balloon innovated by BrosMed provides a dedicated solution for both POT and DOT. The POT™ NC PTCA Balloon Dilatation Catheter offers tremendous promise and adds a state-of-the-art coronary balloon to BrosMed’s leading product portfolio.”
BrosMed will continue to develop innovative medical devices to address complex clinical challenges, support physicians, benefit patients worldwide, and contribute to the advancement of the medical industry.
For more information about POT™ NC PTCA, please visit the BrosMed website or contact us via email at Sales@brosmed.com.
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