Look for Drugs and Conditions

Representative image

Concept Medical Receives FDA Approval for Breakthrough MagicTouch AVF Device in Haemodialysis Management

Concept Medical, a renowned leader in cutting-edge medical device technology, has recently announced a significant milestone: the approval of an Investigational Device Exemption (IDE) by the US FDA for its breakthrough MagicTouch AVF. This innovative device has been designated as a Breakthrough by the FDA and is aimed at treating stenotic lesions of Arteriovenous Fistula (AVF) in the management of Chronic Renal Failure during haemodialysis.

This marks the fifth IDE approval for Concept Medical's MagicTouch product portfolio, following a series of successful approvals for various indications. The recent IDE approval for AVF indication comes swiftly after the previous approvals, highlighting the company's momentum in advancing medical innovation.

The US FDA IDE approval empowers Concept Medical to conduct pivotal clinical studies aimed at gathering crucial safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in treating stenotic lesions of AVF. These studies will support the company's future pre-market approval (PMA) application in the United States.

The MagicTouch AVF device addresses a significant challenge faced by chronic renal failure patients undergoing haemodialysis, wherein repeated blockages of the arteriovenous fistula used for the procedure are common. By offering a novel approach to managing stenotic lesions of arteriovenous fistula, Concept Medical aims to enhance patient outcomes and improve the efficacy of haemodialysis, a vital treatment for individuals with renal failure. This latest approval underscores Concept Medical's unwavering commitment to excellence and innovation in managing stenotic arterial lesions, ultimately leading to improved patient care and quality of life.

Dr. Manish Doshi, the Founder of Concept Medical, expressed his enthusiasm about the FDA approval, stating, "This approval not only reflects our relentless pursuit of innovation but also signifies a pivotal moment in our mission to redefine the treatment landscape for haemodialysis patients. We are eager to witness the positive impact of MagicTouch AVF on patient care and are excited about the upcoming clinical trials."

Concept Medical remains dedicated to pioneering solutions that address the unmet needs of patients. The company is poised to commence the AVF IDE clinical trial for MagicTouch SCB in the upcoming month and is on track to initiate enrolment for the currently approved IDE trials of the MagicTouch product in the US. With a steadfast focus on advancing patient care through innovation, Concept Medical continues to strive towards improving the lives of patients worldwide.

Be first to post your comments

Post your comment

Related Articles

Ad 5