The Latest Cardiac and Vascular News
TAMPA, Fla., Jan. 20, 2025 /PRNewswire/ — Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled. The…
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 Company’s Sirolimus coated balloon. The Company has already received three […]
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 the third IDE approval for Concept Medical’s Sirolimus Coated Balloon […]
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 the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease. CMI […]
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 Future’ which explored the utility of Sirolimus Coated Balloon treatment […]
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 for the treatment of peripheral artery disease in the femoropopliteal […]
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 safety and effectiveness of this combination product. The data generated […]
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 applications of Drug Coated Balloon (DCB) in coronary artery disease […]
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 Balloon versus Standard Angioplasty for the Treatment of Infrapopliteal Occlusions […]
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 the world’s first and the largest head-to-head RCT investigating the […]
