Surat (Gujarat) [India], May 3 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.
Small vessel disease affects up to 30% of patients undergoing PCI, and revascularization of small vessels is challenging due to increased technical failure rates and an elevated risk of restenosis with PCI, which can result in repeated interventions. Small Vessel Disease is also a predictor of Major Adverse Cardiac Events (MACE). 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.
The CE approved Magic Touch SCB is the world’s first Sirolimus-coated Balloon with extensive commercial usage in Europe, major markets of Asia, and the Middle Eastern markets, with over 100,000 patients treated with Magic Touch SCB in these markets. CMI has the distinction of developing the world’s first Sirolimus Coated Balloon and Drug-eluting stent, with over 114 granted patents for its drug delivery platforms. The company has even completed Clinical Trials in Japan, with an expected PMDA approval in Japan soon. These USFDA IDE approvals provide CMI with access to the US market.
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. CMI’s innovation and success in obtaining three IDE approvals in different treatment indications highlight India’s research capabilities in the medical field. This achievement has the potential to be a game changer for the healthcare industry, healthcare professionals, and patients at large, providing with an alternate product for the treatment CAD & PAD.
Dr. Martin Leon, Founder of the 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 and managing director of 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.”
About MagicTouch SCB:
MagicTouch SCB is a CE marked and commercially marketed Sirolimus-coated balloon developed by Concept Medical, using proprietary Nanoluté Technology. MagicTouch SCB has been used in >50,000 patients in major global markets.
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida, and has operational offices in The Netherlands, Singapore, and Brazil, with manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug/pharmaceutical agent across the luminal surfaces of blood vessels.