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Another Breakthrough Designation for Concept Medical

FDA granted the Tampa, FL-based company two breakthrough device designations in less than a 30-day period. Its latest designation is for the MagicTouch AVF's treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure.

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 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 multi-center randomized study to confirm our results.”

This marks the second breakthrough device designation the company received in a 30-day-period. In mid-August, the firm said the MagicTouch PTA was granted breakthrough designation for the treatment of Peripheral Artery Disease (PAD) Below-the-Knee (BTK).

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