Another Breakthrough Designation for Concept Medical

Concept Medical’s MagicTouch AVF might have the “magic touch” when it comes down to nabbing breakthrough device designations. The proposed indication for the latest breakthrough device designation is for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure. Concept Medical said its first pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon was started in Singapore in 2018. Led by Principal Investigator, Dr. Tan Chieh Suai, a multi-disciplinary team of doctors consisting of interventional nephrologists, vascular surgeons and interventional radiologists, is conducting the study entitled “Sirolimus coated angioplasty balloon in the salvage of thrombosed arteriovenous graft” in Singapore General Hospital. Suai is also Senior Consultant and Director for the Interventional Nephrology Program in the Department of Renal Medicine in Singapore General Hospital and Duke-NUS Medical School. “The award of the breakthrough Device Designation for the use of sirolimus coated balloons in dialysis access is fantastic news for patients on hemodialysis, as there is an urgent need for effective and durable treatment for narrowing (stenosis) within the dialysis circuit,” Suai said in a release. “We are very encouraged by the early results of our ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news