Concept Medical has been granted Breakthrough Device Designation from the FDA for the MagicTouch AVF, sirolimus-coated, balloon catheter for the management of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure.
The proposed indications for the MagicTouch AVF devices are for it to be used, after appropriate vessel preparation, to treat stenotic lesions of dysfunctional native arteriovenous dialysis fistula or graft with 4 mm to 12 mm diameter and up to 100 mm in length.
A pilot study to investigate the safety and efficacy of Magic Touch sirolimus balloon in vascular access interventions was commenced in last year. Led by Tan Chieh Suai, a multi-disciplinary team of doctors consisting of interventional nephrologists, vascular surgeons and interventional radiologists, is conducting the study (Sirolimus coated angioplasty balloon in the salvage of thrombosed arteriovenous graft) at in Singapore General Hospital (Singapore).
In response to the breakthrough designation for Magic Touch AVF, Suai says: “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. We are very encouraged by the early results of our pilot study in Singapore and grateful to all patients who had participated in the study. In particular, I am most touched by feedback given by one of the patients: ‘So far so good. This new study helped me a lot, saved me from repeated procedures in which I used to need intervention every three months; Now, I can have more time at home, rather than in a hospital.’ We look forward to the launch of a larger multicentre randomised study to confirm our results.”
The breakthrough device designation granted to Magic Touch AVF provides Concept Medical with the opportunity to interact with the FDA’s experts. Under the programme, FDA will provide the company with priority review and interactive communication regarding device development and clinical trial protocols through to commercialisation decisions.