Another Breakthrough Designation for Concept Medical
Concept Medicalâs MagicTouch AVF might have the âmagic touchâ 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 âSirolimus coated angioplasty balloon in the salvage of thrombosed arteriovenous graftâ 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.
âThe 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,â Suai said in a release. âWe are very encouraged by the early results of our ...
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news