The US Food and Drug Administration (FDA) has granted Concept Medical an investigational device exemption (IDE) for its MagicTouch arteriovenous fistula (AVF) catheter, allowing the company to initiate a clinical study with the device.
The IDE is for the treatment of stenotic lesions of AVF in patients undergoing haemodialysis management for chronic renal failure. AVFs are abnormal connections created between arteries and veins for dialysis access. For patients undergoing multiple haemodialysis procedures, repeated blockages can occur.
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Concept Medical has designed a sirolimus-coated balloon to treat these lesions. Sirolimus is an immunosuppressant that is used to treat vascular problems such as abnormal clotting.
Concept stated that the IDE for MagicTouch AVF will help with data generation for a future pre-market approval (PMA) application in the US.
The trial is slated to start in the coming month, with enrollment for other MagicTouch devices to begin “on track”.
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Concept Medical’s founder Dr Manish Doshi said: “We look forward to MagicTouch AVF’s positive impact on patient care and are excited about the upcoming clinical trials.”
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By GlobalDataThe balloon is part of the US company’s MagicTouch range, which now has five IDEs in total. This includes studies for the treatment of femoral artery disease, coronary in-stent restenosis, and below-the-knee peripheral artery diseases, amongst others.
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