Concept Medical has received a breakthrough designation from the FDA for its balloon catheter designed to open a path through a collapsed or narrowed vessel used to access a patient’s bloodstream during a dialysis procedure.
The company’s sirolimus-coated Magic Touch AVF percutaneous device aims to clear dysfunctional fistulas or grafts up to 100 mm in length, following the development of a stenotic lesion that slows blood flow.
Typically created in the forearm through a surgical procedure, a fistula connects an artery and vein to expand the vein’s size and blood flow, in order to provide easier access to the bloodstream for regular dialysis.
This can be done with the patient’s own vessels, or through a biocompatible tube implant. Complications, however, can include infections, thrombosis and aneurysms resulting in reduced blood flow to the limb. Concept Medical began its first pilot study of the device in Singapore last year.
"The award of the breakthrough device designation for the use of sirolimus-coated balloons in dialysis access is fantastic news for patients on hemodialysis, as there is an urgent need for effective and durable treatment for narrowing within the dialysis circuit,” study principal investigator Tan Chieh Suai, director of the Interventional Nephrology Program at Singapore General Hospital and Duke-NUS Medical School, said in a statement.
The company said its data have been promising through early follow-up, with no procedural failures and no repeat interventions in patients who received treatment to a native fistula.
“We look forward to the launch of a larger multi-center randomized study to confirm our results," Tan said.
In the past month, the company also received an FDA breakthrough designation for its sirolimus-eluting balloon catheter designed for treating peripheral artery disease below the knee. It had previously received the designation in April for its catheter for coronary artery disease.