Concept Medical Inc.
Tampa, Fla. (ots/PRNewswire)
The US Food and Drug Administration (FDA) has Investigational Device Exemption (IDE) approval for the new device Magic Touch Sirolimus Coated Balloon (SCB) from Concept Medical Inc. for the treatment of small vessels (SV) in the coronary arteries.
The U.S. Food and Drug Administration (FDA) issued the third IDE clearance for Concept Medical’s Sirolimus Coated Balloon – MagicTouch SCB on April 25, 2023. In addition to this latest IDE approval for the treatment of small vessels, Concept Medical received two additional IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent-Restenose (ISR) and for the Treatment below the knee (PTA).
Small vessel disease is common in patients undergoing PCI and has been documented in up to 30% of cases. Small vessel myocardial revascularization remains a challenge due to the increased rate of technical failure after coronary artery bypass graft surgery and the increased risk of restenosis with PCI, leading to re-procedures. Small vessel disease also remains an independent predictor of major adverse cardiac events (MACE).
The current IDE approval makes it possible Concept Medicalto initiate a pivotal clinical study to demonstrate the safety and efficacy of the MagicTouch SCB in small vessel coronary artery disease. Data generated from this IDE clinical study will support a future Pre-Market Authorization (PMA) submission in the United States.
MagicTouch SCB is the world‘s first sirolimus coated balloon with extensive commercial use in Europe, key Asian and Middle Eastern markets. More than 100,000 patients have been treated with MagicTouch SCB in these markets.
There are currently no FDA-approved drug-eluting balloons for the treatment of CAD in the United States. The physician’s choice is limited to drug-eluting stents and uncoated balloons. MagicTouch SCB has already been extensively studied in numerous clinical studies worldwide, notably in the EASTBOURNE registry (2123 patients), NANOLUTE and ongoing studies such as TRANSFORM 1, TRANSFORM 2, GINGER, TITAN and Hybrid Bifurcation DEB. Sirolimus has already been shown to be safer in treating coronary artery disease.
dr Martin Leon, MD (Founder and Chairman Emeritus, Cardiovascular Research Foundation), who will direct the upcoming IDE studies, emphasizes the importance of this achievement: “FDA approval to initiate the MAGICAL-SV clinical study with the sirolimus-coated MagicTouch balloon with novel coating technology represents a milestone in our decades-long search for an optimal therapy to treat patients with small vessel obstructive coronary disease. Our clinical researchers in the USA are excited and excited to work closely with the Cardiovascular Research Foundation and Concept Medical with begin enrolling patients.”
About MagicTouch SCB:
MagicTouch SCB is a CE marked and commercially marketed sirolimus coated balloon manufactured by Concept Medical using proprietary Nanoluté-Technology was developed. MagicTouch SCB has been used on more than 50,000 patients in major global markets.
About Concept Medical Inc (CMI):
CMI is headquartered in Tampa, Florida with offices in the Netherlands, Singapore and Brazil and manufacturing facilities in India. CMI specializes in developing unique combination products with a patented coating technology that can deliver any drug/active pharmaceutical ingredient across the luminal surfaces of blood vessels.
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Press contact:
Roshan Bellose,
[email protected],
Tel.: 2616186889
Original content from: Concept Medical Inc., transmitted by news aktuell