Pharmabiz

US FDA grants Investigational Device Exemption to Concept Medical’s Magic Touch Sirolimus Coated Balloon to treat below the knee arterial disease

Concept Medical Inc. (CMI), a company specializes in developing drug-delivery systems, announced that on 9th February 2023 the US FDA has granted Investigational Device Exemption (IDE) for its Magic ...
Business Insider

IMPRESSION - A randomised trial to evaluate the efficacy of MagicTouch Sirolimus Coated Balloon in Dysfunctional Fistula progresses rapidly

SINGAPORE, June 23, 2021 /PRNewswire/ -- Concept Medical Inc., focused on vascular intervention drug delivery devices, has updated the progress of IMPRESSION (sIroliMus coated balloon angioPlasty ...
TCTMD

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

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 ...
MedPage Today

Sirolimus Balloons Show Promise in Treating Coronary In-Stent Restenosis

For interventionalists hoping that a new generation of coronary balloons might improve treatment of in-stent restenosis (ISR), contemporary registry data were encouraging. In a propensity ...
Business Wire

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 ...
TCTMD

TRANSFORM 1 Enrollment Completed: A Crucial RCT ready to redefine the DCB Angioplasty Mechanism

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 ...
PR Newswire

SIRPAD - WORLD'S LARGEST RCT INVESTIGATING MAGICTOUCH PTA SIROLIMUS COATED BALLOON COMPLETES PATIENT ENROLMENT

The SirPAD (Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated or uncoated balloon) randomised controlled ...