The Latest Cardiac and Vascular News
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 Native Coronary Vessel Treatment domain. TRANSFORM II RCT, determined to […]
JENA, Germany, May 24, 2021 /PRNewswire/ — Concept Medical Inc., focused on vascular intervention drug delivery devices, releases status updates of SIRONA Randomized Control Trial (RCT) which compares head-to-head, SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in femoropopliteal arterial diseases (SIRONA). SIRONA is the world’s first RCT investigating the use of Sirolimus drug coated balloon (DCB) (MagicTouch PTA – Concept Medical) […]
TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed […]
ZURICH, November 10, 2020 / PRNewswire / – Concept Medical Inc., a company focused on medical devices for drug delivery in vascular interventions, announced the enrollment of the first patient in the SirPAD clinical study ( Sir olimus in P eripheral A rtery D isease) (Sirolimus in peripheral arterial disease). The SirPAD is the first randomized controlled clinical trial and for all who […]
Concept Medical announces index patient enrolment in world’s first Randomized Controlled Trial with Sirolimus Coated Balloon for the treatment of Superficial Femoral Artery (SFA) in Peripheral Artery Disease SINGAPORE, Sept. 14, 2020 /PRNewswire/ — Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the FUTURE […]
COTIGNOLA, Italy, Sept. 2, 2020 /PRNewswire/ — Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the TRANSFORM-1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch sirolimus coated balloon). TRANSFORM-1 is a prospective, randomized, multi-center, European study focusing on coronary artery lesions in small vessels with a […]
Concept Medical B.V. with its headquarters in Tampa, Florida has announced that on 16th October 2019, they have received the CE certification for their MagicTouch group of products. HOEVELAKEN, Netherlands, Oct. 18, 2019 /PRNewswire/ — The CE certified products/brands are as listed below: MagicTouch – PTA (Sirolimus Coated PTA Balloon Catheter) for peripheral arterial disease MagicTouch – ED (Sirolimus […]
TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure. The FDA received Concept […]
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first ‘Breakthrough Device Designation’ received by Concept Medical […]
TAMPA, Florida, May 2, 2019 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to […]
