SIS Medical AG Pronounces The US-launch And The First US-treatment With The Tremendous-Excessive-Strain Balloon – OPN NC® – With TWIN-Wall Know-how

SIS Medical AG (Swiss Interventional Techniques), a globally main developer, producer and distributor of high-quality and high-performance merchandise within the area of interventional cardiology, pronounces the launch of its lead product OPN NC® PTCA Dilatation Catheter with TWIN-Wall know-how within the US. The product extends remedy choices by excessive efficiency and security in addition to offering successrates the place different balloons fail. It’s distributed by Worldwide Improvements & Applied sciences, Inc. (producer and distributor of RADPAD® Radiation Safety Merchandise), which is headquartered in Lenexa, Kansas.

The OPN NC® catheter has a singular TWIN-Wall design, invented at SIS Medical AG, offering an excellent excessive strain resistance with a rated burst strain of 35 atm with a really low compliance. These efficiency options permit for an ideal preparation of difficult lesions previous to stenting with out over-dilating of the blood vessel. The system may also be utilized for post-dilatation of under-expanded stents. OPN NC® coronary balloon is the one Tremendous-Excessive-Strain coronary balloon rated with 35 atm which obtained the 510(okay) clearance by the U.S. Meals & Drug Administration (cleared underneath the quantity K212393 in March 2022).

The primary US remedy came about within the Morristown Medical Middle in New Jersey by Interventional Heart specialist, Dr. Philippe Genereux. “I used to be extraordinarily glad with the efficiency of the OPN NC® balloon. We had been profitable in effectively treating a number of sufferers with very advanced and calcified lesions. The OPN NC® balloon is a vital device for operators treating resistant lesions, restenosis, or to deal with acutely under-expanded stent, and is a real cost-effective know-how in comparison with different units.”

“Our OPN NC® balloon with TWIN-Wall know-how has already been efficiently used for a number of years in Europe and different international locations. Greater than 140,000 sufferers have been handled with the product thus far. With the US launch, our firm has reached one more vital milestone. The primary circumstances on the Morristown Medical Middle have proven a powerful want for our know-how to enhance the remedy of difficult coronary lesions in US sufferers. Many different US hospitals will likely be introducing the OPN NC® inside the subsequent few weeks”, says Sergej Kammerzell, CEO of SIS Medical AG.

“Entry to the US market may have an awesome impression on the additional improvement, status, and continued worldwide progress of SIS Medical AG”, provides Willi Zwahlen, VP Gross sales & Advertising and marketing, Founder and Board Member of SIS Medical AG. “The US launch is a key-element of our technique to make OPN NC® out there in all main international markets.”

Eric Radtke, Vice President Gross sales & Advertising and marketing at RADPAD, additional concludes: “OPN NC® is an thrilling product that we will present to a large buyer base within the US. We stay up for including worth to our buyer services by delivering one other high-quality, life saving system.”

John Cadwalader, CEO at RADPAD, states: “We’re excited to be the U.S. distributor for OPN NC® and stay up for being part of offering a significant step ahead in interventional drugs within the US.”