TAMPA, Fla. , April 2, 2024 /PRNewswire/ -- Concept Medical has been granted 'IDE Approval' from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, to initiate a clinical study for the treatment of stenotic lesions of Arteriovenous Fistula in the Haemodialysis management of Chronic Renal Failure.
Concept Medical has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
Concept Medical has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
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 (CAD) can be broadened.
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.
Singapore's Concept Medical Inc., focused on vascular intervention drug delivery devices, on 15 Sep 2020 has announced the enrolment of the first patient in the FUTURE SFA (Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Superficial Femoral Artery and Popliteal Artery Disease).