Tag: Concept Medical

SIRONA – The world’s first and largest RCT comparing Sirolimus V/S Paclitaxel balloon for the treatment of Peripheral Arterial Disease progresses rapidly

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 […]

Small vessels can cause big problems; MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions

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 […]

The largest controlled clinical study in the world to investigate the use of the MagicTouch PTA sirolimus-coated balloon for the treatment of peripheral arterial disease

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). […]

Concept Medical announces index patient enrolment in world’s first Randomized Controlled Trial…

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, […]

Concept Medical announces enrolment of index patient in the crucial Transform -1 RCT using MagicTouch sirolimus coated balloon for small coronary vessels

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 […]

Concept Medical is Granted CE Certification for Their Sirolimus Coated MagicTouch Group of Products

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 […]

Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon

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 […]

Concept Medical Inc. Granted 2nd ‘Breakthrough Device Designation’ From the FDA for Its MagicTouch PTA Sirolimus Coated Balloon, for the Treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK) Indication

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 […]

Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From FDA for Its MagicTouch Sirolimus Coated Balloon

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 […]

Concept Medical Inc. Raises $60mn for Investigational Device Exemption (IDE) for the World’s First Sirolimus-Coated Balloon

SURAT, India, Oct. 9, 2018 /PRNewswire/ — Concept Medical Inc. Raises $60mn For Investigational Device Exemption (IDE) For The World’s First Sirolimus-Coated Balloon. Concept Medical Inc. (CMI) has approached the FDA for an Investigational Device Exemption (IDE) for their Sirolimus-Coated Balloon (DCB). To support this […]