SIS Medical’s OPN NC PTCA Dilatation Catheter Is Launched in United States

February 8, 2023—SIS Medical AG (Swiss Interventional Systems) recently announced the United States launch of its lead product, the OPN NC percutaneous transluminal coronary angioplasty (PTCA) dilatation catheter with Twin-Wall technology.

The OPN NC PTCA dilatation catheter received FDA 510(k) clearance in March 2022.

SIS Medical is a developer, manufacturer, and distributor of interventional cardiology devices based in Frauenfeld, Switzerland. The company’s OPN NC device is distributed in the United States by Worldwide Innovations & Technologies, Inc., which is the manufacturer and distributor of Radpad radiation protection products and is headquartered in Lenexa, Kansas.

According to the company, the OPN NC device’s Twin-Wall design provides a super-high-pressure resistance with a rated burst pressure of 35 atm with a very low compliance. These performance features allow for a perfect preparation of challenging lesions before stenting without over-dilating the blood vessel. The device can also be applied for postdilatation of under-expanded stents.

The first treatment with the device was performed by interventional cardiologist Philippe Généreux, MD, at the Morristown Medical Center in Morristown, New Jersey.

“I was extremely satisfied with the performance of the OPN NC balloon,” commented Dr. Généreux in the company’s press release. “We were successful in efficiently treating multiple patients with very complex and calcified lesions. The OPN NC balloon is an essential tool for operators treating resistant lesions, restenosis, or to treat acutely under-expanded stent, and is a true cost-effective technology compared to other devices.”