Concept Medical, a leading innovator in medical device technology with its manufacturing base in Surat, Gujarat, has secured a significant milestone with the U.S. Food and Drug Administration's (FDA) Investigational Device Exemption (IDE) approval for its MagicTouch AVF. This Sirolimus drug-coated balloon (DCB) catheter is poised to revolutionize the treatment of stenotic lesions in Arteriovenous Fistula (AVF) for chronic renal failure patients undergoing haemodialysis.
This marks Concept Medical's fifth consecutive IDE approval from the US FDA for its MagicTouch product portfolio. Previously, the company received approvals for various applications, demonstrating their dedication to expanding the reach of this innovative technology.
The IDE approval allows Concept Medical to conduct pivotal clinical studies. This vital step will gather crucial safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in AV fistula treatment. The data collected will pave the way for a future Premarket Approval (PMA) application in the USA.
Enhancing Patient Outcomes in Haemodialysis
Chronic renal failure patients undergoing haemodialysis, a life-sustaining treatment, often face repeated blockages of the arteriovenous fistula used for the procedure. These blockages, known as stenotic lesions, necessitate additional procedures. The MagicTouch AVF offers a novel approach to managing these lesions, potentially improving patient outcomes in this critical treatment.
Dr. Manish Doshi, Founder of Concept Medical, expressed his enthusiasm: "This approval is a testament to our unwavering pursuit of innovation. It signifies a pivotal moment in our mission to redefine the treatment landscape for haemodialysis patients. We are confident that MagicTouch AVF will have a positive impact on patient care, and we eagerly anticipate the upcoming clinical trials."
Commitment to Pioneering Solutions
Concept Medical prioritizes addressing unmet patient needs through pioneering solutions. They are gearing up to commence the AVF IDE clinical trial for MagicTouch SCB within the coming month. Enrollment for their other ongoing US IDE trials utilizing the MagicTouch product line is also on track to begin soon.
