OPN NC “super-high-pressure” coronary balloon launches in USA


SIS Medical AG has announced the launch of its OPN NC percutaneous transluminal coronary angioplasty (PTCA) dilatation catheter with ‘Twin-Wall’ technology in the USA.

“The product extends treatment options by high performance and safety as well as providing success rates where other balloons fail,” SIS Medical said of the device in a press release. The catheter is to be distributed by Worldwide Innovations & Technologies, which is headquartered in Lenexa, Kansas.

SIS Medical AG has developed the Twin-Wall technology, which it says provides a super high pressure resistance with a rated burst pressure of 35atm with a very low compliance. These features allow for preparation of challenging lesions prior to stenting without over-dilating of the blood vessel, the company says.  The device can also be applied for post-dilatation of under-expanded stents.

OPN NC coronary balloon is the only super-high-pressure coronary balloon rated with 35atm which has received 510(k) clearance from the US Food & Drug Administration (FDA), SIS Medical claims.

The first US procedure using the device  was undertaken by Philippe Genereux (Morristown Medical Center, Morristown, USA). “I was extremely satisfied with the performance of the OPN NC balloon,” said Genereux. “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.”


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