US FDA grants ‘Breakthrough Device Designation’ to Concept Medical for its MagicTouch AVF Sirolimus Coated Balloon Catheter

MagicTouch Sirolimus Coated Balloon Catheter can lower the complications involved with the traditional treatment method.

According to the National Kidney Foundation, Over 2 million people worldwide currently receive treatment with dialysis or a kidney transplant to stay alive. Hemodialysis is the process of purifying blood through the use of a machine which requires tubes to be injected into the patient’s body to allow the flow of blood into the dialysis machine which then passes through a filter called dialyzer. The filtered blood is then reverted back into the patient’s body. The use of dialysis has been around for a while but there exists a constant need to make the whole process much simpler. Thanks to Concept Medical, the process may become much simpler in the future because of its latest device-MagicTouch AVF, the Sirolimus drug Coated Balloon Catheter, for which the company received a ‘Breakthrough Device Designation’ from the US FDA (Food and Drug Administration).

The MagicTouch AVF- Sirolimus Coated Balloon (DCB) Catheter is meant for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure.

“The FDA received Concept Medical Inc. (CMI) request to designate MagicTouch AVF as a Breakthrough Device in July 2019. The proposed indications for the Breakthrough Device Designation for “The MagicTouch Sirolimus Coated Balloon Catheter is indicated for use in percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistula or graft with 4 mm to 12 mm diameter and up to 100 mm in length.” CMI on Aug. 28 was informed by the FDA that “your combination product and proposed indication for use meet the criteria and have been granted designation as a Breakthrough Device”..”

The hemodialysis procedure requires vascular access which is created by surgical means most commonly in the forearm. The two types of vascular access intended for long-term use are AVF and AVG which resulted in common complications such as infections, stenosis of the fistula, thrombosis, aneurysm, and limb ischemia. On the other hand, the PTA procedure can open a blocked blood vessel using a small catheter, with a “balloon” at one end. Sirolimus is the most widely used drug for such purpose, and Concept Medical Inc. has truly innovated the development of the Sirolimus delivery platform technology used in the MagicTouch AVF ballons for the treatment of stenotic lesions in AVF and AVG.


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