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
Concept Medical has received its third Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Sirolimus-Coated Balloon, Magic Touch SCB, for the treatment of Small Vessels (SV) in Coronary Arteries.
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.
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.”