FDA Approves Concept Medical's Sirolimus Drug-Coated Balloon

Concept Medical, which is among the most advanced medical device technology producers, has gotten the green light to continue the clinical trial for its FDA breakthrough-approved AVF MagicTouch for stenotic lesions of Arteriovenous Fistula (AVF) documented for the hemodialysis management of patients suffering from chronic renal failure with the IDE certificate.

Satisfying affordability and quality aspects, the company has collected four other US FDA IDE qualifications for its MagicTouch product set for additional indications. The latest one is the fifth of this one-scream string of IDE approvals that gives them approval for using their AVF indication.

The US FDA IDE approval granted to Concept Medical opens the window to conducting pivotal clinical studies to prove the safety and efficacy of the Magic Touch Sirolimus Coated Balloon in A.V. fistula and consider a future USA pre-market approval (PMA) application.

Frequent erythrodialysis, required for the hemodialysis of a chronic patient with renal failure, often leads to the blockage common in the arteriovenous fistula, the vessel used for this procedure. MagicTouch AVF is designed to alleviate atherosclerotic lesions of A.V.

Fistulas, with its cutting-edge technology, is thus bringing fresh vigor to the field of hemodialysis offered to patients with renal failure. This latest approval bears testimony to Concept Medical’s vigilance in the perfect management of atherosclerotic arterial disease, which lifts care and quality of life.