Concept Medical said yesterday that it won breakthrough designation from the FDA for its MagicTouch AVF drug-coated balloon.
MagicTouch AVF is designed to treat stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure. India-based Concept Medical’s device is indicated for use in percutaneous transluminal angioplasty.
The PTA procedure, using Concept Medical’s MagicTouch AVF, is intended to open a blocked blood vessel and deliver drugs — in this case, sirolimus — to inhibit the inflammatory pathways.
Concept Medical launched a pilot study of MagicTouch for vascular access interventions in Singapore last year.
“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 within the dialysis circuit,” principal investigator Dr. Tan Chieh Suai said in prepared remarks. “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.”
“We are still in the early stage in the clinical study of drug-coated balloons for hemodialysis access patients,” added Dr. Tjun Yip Tang of Singapore General Hospital. “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. Our preliminary data using the MagicTouch sirolimus-coated balloon at the graft-vein junction of blocked AV grafts, and within native AV fistulas, 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, but we are highly encouraged by this initial pilot data.”
It’s the third breakthrough designation for Concept, following a determination in May for coronary in-stent restenosis and a below-the-knee determination earlier this month.