Industry News: The FDA Granted an Investigational Device Exemption Approval for Sirolimus Coated Balloon For the Treatment of Small Vessels In Coronary Arteries

Concept Medical has received its third US FDA IDE approval for the MagicTouch – Sirolimus Coated Balloon in Small Vessel Indication.

The FDA, granted the third IDE approval for Concept Medical’s Sirolimus Coated Balloon – MagicTouch SCB. Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA). Small vessel disease is common among patients undergoing PCI and has been documented in up to 30% of cases and Myocardial revascularization of small vessels remains challenging owing to increased rates of technical failure following coronary artery bypass graft surgery and an increased risk of restenosis with PCI resulting with repeated interventions. Small Vessel Disease also remains an independent predictor of major adverse cardiac events (MACE).

Currently, there are no FDA approved Drug Coated Balloons for the treatment of CAD in the USA. The physicians’ choices are restricted to Drug Eluting Stents and uncoated Balloons. MagicTouch SCB 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. The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease. The data generated from this IDE clinical study will support a future pre-market approval (PMA) application in the USA.

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. MagicTouch SCB is the world’s first Sirolimus coated Balloon with extensive commercial usage in Europe, major markets of Asia and the Mid-Eastern markets. More than 100 thousand patients have been treated with MagicTouch SCB in these markets. For more information go to, MagicTouch SCB.

Source: Reprint courtesy PRNewswire; Photo courtesy MagicTouch

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