August 28, 2019
FDA Grants Breakthrough Device Designation for Concept Medical's MagicTouch AVF Sirolimus-Coated Balloon
August 29, 2019—Concept Medical Inc. announced that it has been granted FDA Breakthrough Device designation for the company's MagicTouch arteriovenous fistula (AVF) sirolimus-coated balloon (SCB) catheter for the treatment of stenotic lesions of AVFs or AV grafts (AVGs) in hemodialysis treatment of renal failure. Under the program, FDA will provide the company with priority review and interactive communication regarding device development and clinical trial protocols through to commercialization decisions.
The proposed indications for the Breakthrough Device designation for the device are for use in percutaneous transluminal angioplasty (PTA) after appropriate vessel preparation for treating stenotic lesions of dysfunctional native dialysis AVFs or AVGs with 4- to 12-mm diameters and up to 100 mm in length.
Tan Chieh Suai, MD, is Principal Investigator of the first pilot study to investigate the safety and efficacy of the Magic Touch PTA SCB in vascular access interventions. Started in Singapore in 2018, the study (“Sirolimus-coated angioplasty balloon in the salvage of thrombosed arteriovenous graft”) is being conducted by a multidisciplinary team of interventional nephrologists, vascular surgeons, and interventional radiologists at Singapore General Hospital. Dr. Suai is Adjunct Assistant Professor, Senior Consultant, and Director for the Interventional Nephrology program in the Department of Renal Medicine at Singapore General Hospital and Duke-NUS Medical School.
In response to the breakthrough designation for Magic Touch AVF, Dr. Suai commented in the company’s announcement, “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. 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 and saved me from repeated procedures in which I used to need intervention every 3 months. Now, I can have more time at home, rather than in a hospital.’ We look forward to the launch of a larger multicenter randomized study to confirm our results.”
Tjun Yip Tang, MD, Associate Professor and Consultant Vascular and Endovascular Surgeon at Singapore General Hospital, added, “We are still in the early stage in the clinical study of drug-coated balloons for hemodialysis 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 anatomic or clinical subtype presentations. Our preliminary data using the Magic Touch SCB at the graft-vein junction of blocked AVGs, and within native AVFs, have been promising to date, with an excellent safety profile and patient acceptability. Technical and procedural success has been 100%. We have yet to repeat intervention in those who have had SCB elution to their native fistula, but the follow-up is still early, and we are highly encouraged by this initial pilot data.”