%20(8).jpg)
Concept Medical Receives Third US FDA’s IDE Approval for Its Magictouch – Sirolimus Coated Balloon in Small Vessel Indication
Surat (Gujarat) [India], May 1: 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 […]
Surat (Gujarat) [India], May 1: 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.
