For the treatment of Small Vessel Indication in Coronary Arteries

Concept Medical Inc. (CMI), a global leader in drug delivery devices, has received its third Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for its novel Sirolimus-Coated Balloon, Magic Touch SCB, for the treatment of Small Vessels (SV) in Coronary Arteries.

This milestone comes after CMI received IDE approvals for Magic Touch SCB to treat Coronary In-Stent Restenosis (ISR) in September 2022 and Magic Touch PTA to treat “Below the Knee” Peripheral Arterial Diseases (PAD) in February 2022.

The IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and effectiveness data for the Magic Touch Sirolimus Coated Balloon in small vessel coronary disease. This data will support a future pre-market approval (PMA) application in the USA, providing patients and physicians with an alternate product for the treatment of CAD.

Currently, there are no FDA approved Drug Coated Balloons for the treatment of CAD in the USA, and the patients are limited to the availability of Drug Eluting Stents and uncoated Balloons. MagicTouch has already been widely studied globally in multiple clinical trials, most notably the EASTBOURNE Registry (2123 patients), NANOLUTE, and ongoing trials like the TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and Hybrid Bifurcation DEB. Sirolimus has already proven to be safer in coronary artery disease treatment.

Notably, no Indian company has received IDE approval for a Drug-Coated Balloon in the USA, either in the Peripheral or Coronary indications. This achievement has the potential to be a game changer for the healthcare industry, healthcare professionals, and patients at large, providing an alternate product for the treatment CAD & PAD.

Dr. Martin Leon, Founder, Cardiovascular Research Foundation, will lead the coming IDE trials and stresses the importance of this achievement, stating, “The FDA-approval to initiate the MAGICAL -SV Clinical trial using the Magic Touch sirolimus-covered balloon with Nanolute technology represents a landmark event in our decades-long quest to find an optimal therapy to manage patients with small vessel coronary obstructive disease.”

Dr Manish Doshi, Founder & MD, Concept Medical, expressed his appreciation for the approvals, stating, “We are deeply honored to receive three IDE approvals from the US FDA for our Sirolimus drug-coated balloons for the treatment of coronary and peripheral arterial diseases. This brings us closer to offering innovative treatment options to patients in the US and represents a significant leap in the field of Vascular Space for our flagship product, ‘Magic Touch,’ which is the world’s first Sirolimus Coated Balloon with roots in INDIA making the country proud.”