The Latest Cardiac and Vascular News
TAMPA, Fla., May 29, 2023 /PRNewswire/ — The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval for the […]
TAMPA, Fla., May 1, 2023 /PRNewswire/ — 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 […]
TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ — Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon. The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below […]
TAMPA, Fla., Dec. 2, 2022 /PRNewswire/ — VEITH 2022 witnessed a surge of supporting clinical data for Sirolimus Coated Balloon in the treatment of Below-the-Knee (BTK) disease. Concept Medical Inc. hosted a lunch symposium titled ‘Sirolimus Coated Balloon in PAD Treatment: Choice of The […]
TAMPA, Fla., Oct. 21, 2022 /PRNewswire/ — Concept Medical Inc. announces the successful completion of the SIRONA – World’s first and the largest head-to-head RCT investigating the use of Sirolimus Drug Coated Balloon (DCB) (Magic Touch PTA – Concept Medical Inc.) V/S Paclitaxel DCB angioplasty […]
TAMPA, Fla., Sept. 17, 2022 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR). US FDA’s IDE approval allows the MagicTouch SCB to be used in a pivotal clinical study to support […]
BIRMINGHAM, England, Sept. 13, 2022 /PRNewswire/ — Concept Medical announces the successful completion of the TRANSFORM 1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch Sirolimus Coated Balloon). The Randomized Controlled Trial (RCT) was conceptualized with the aim of understanding how the treatment indications and […]
Concept Medical Inc., a pioneer in developing drug delivery device platforms for vascular intervention, has announced the initiation of LIMES trial. MÜNSTER, Germany, July 29, 2022 /PRNewswire/ — LIMES (Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of SiroLIMus Drug Coated […]
JENA, Germany, Feb. 9, 2022 /PRNewswire/ — Concept Medical Inc., focused on vascular intervention drug delivery devices, releases the second status update of SIRONA RCT (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery), as the trial completes half the targeted enrolment. SIRONA is […]
MILANO, Italy, Jan. 28, 2022 /PRNewswire/ — FONDAZIONE Ricerca e Innovazione Cardiovascolare, Milano, focused on cardiovascular research, reports the first patient enrolment of the TRANSFORM II Randomized Controlled Trial (Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels) setting in motion a crucial trial in the […]
