News | Drug-Eluting Balloons | May 12, 2023

Concept Medical's Receives FDA Approval for the MagicTouch-Sirolimus Coated Balloon

Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the Magic Touch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA) 

Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the Magic Touch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA)

May 12, 2023 — The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries. 

US FDA, on the 25th of April 2023, 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 Magic Touch 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). 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. 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. 

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. 

Dr. Martin Leon, MD (Founder and Chairman Emeritus, Cardiovascular Research Foundation), who will lead the coming IDE Trials, stresses on the importance of this achievement “The FDA-approval to initiate the MAGICAL -SV Clinical trial using the Magic Touch sirolimus-covered balloon with novel coating technology represents a landmark event in our decades-long quest to find an optimal therapy to manage patients with small vessel coronary obstructive disease. Our U.S. clinical investigators are thrilled and anxious to begin enrolment in close collaboration with the Cardiovascular Research Foundation and Concept Medical.” 

For more information: www.conceptmedical.com 

Concept Medical Granted FDA Breakthrough Device Designation for MagicTouch PTA Sirolimus Coated Balloon 

New AHA Statement Highlights Need for Early Diagnosis, Treatment With Critical Limb Ischemia 


Related Content

News | Cardiovascular Clinical Studies

November 29, 2023 — Inari Medical, Inc., a medical device company with a mission to treat and transform the lives of ...

Home November 29, 2023
Home
News | Cardiovascular Clinical Studies

November 29, 2023 — Foldax, Inc., a leader in the development of innovative, polymer heart valves, today announced ...

Home November 29, 2023
Home
News | Cardiovascular Clinical Studies

November 28, 2023 — Abiomed, part of Johnson & Johnson MedTech[1], announces the first patient in the world has been ...

Home November 28, 2023
Home
News | Cardiovascular Clinical Studies

November 27, 2023 — Esperion announced the presentation of results from a pre-specified, exploratory analysis of CLEAR ...

Home November 27, 2023
Home
News | Cardiovascular Clinical Studies

November 22, 2023 — The first clinical trial to challenge the routine implantation of a defibrillator in myocardial ...

Home November 22, 2023
Home
News | Cardiovascular Clinical Studies

November 15, 2023 — Researchers at the University of Leicester have discovered the mechanism by which cholesterol in our ...

Home November 15, 2023
Home
News | Cardiovascular Clinical Studies

November 6, 2023 — Bristol Myers Squibb announced that research across the company’s cardiovascular franchise will be ...

Home November 06, 2023
Home
News | Cardiovascular Clinical Studies

October 20, 2023 — JenaValve Technology, Inc., developer and manufacturer of the Trilogy Transcatheter Heart Valve (THV) ...

Home October 20, 2023
Home
News | Cardiovascular Clinical Studies

October 12, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

Home October 12, 2023
Home
Subscribe Now