Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for MagicTouch AVF, its sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure.
The FDA received a request from Concept Medical to designate MagicTouch AVF as a breakthrough device in July 2019. The proposed indications for the breakthrough device designation for the MagicTouch sirolimus-coated balloon catheter is indicated for use in percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistula or graft with 4–12 mm diameter and up to 100mm in length.”
On 28 August, Concept Medical was informed by the FDA that “your combination product and proposed indication for use meet the criteria and have been granted designation as a breakthrough device.”
The world’s first pilot study to investigate the safety and efficacy of Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus balloon in vascular access interventions was started in Singapore in 2018. Led by principal investigator, 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.
In response to the breakthrough designation for Magic Touch AVF, adjunct assistant professor Tan Chieh Suai, senior consultant and director for the Interventional Nephrology Program in the Department of Renal Medicine in Singapore General Hospital and Duke-NUS Medical School, said, “The award of the breakthrough device designation for the use of sirolimus-coated balloons in dialysis access is fantastic news for patients on haemodialysis, as there is an urgent need for effective and durable treatment for narrowing (stenosis) within the dialysis circuit.”
Tjun Yip Tang, associate professor and consultant vascular and endovascular surgeon, Singapore General Hospital, Singapore has highly appreciated the success of Concept Medical and said, “We are still in the early stage in the clinical study of drug-coated balloons for haemodialysis access patients. The paclitaxel-based technology study results have certainly been encouraging, but more research is required to determine if other devices may prove to be more effective or uniquely beneficial for specific anatomical or clinical subtype presentations.”
The breakthrough device designation granted to Magic Touch AVF offers Concept Medical an opportunity to interact with the FDA’s experts. Under the programme, the FDA will provide Concept Medical with priority review and interactive communication regarding device development and clinical trial protocols through to commercialisation decisions.
