4 recent device updates in cardiac, vascular intervention

Cardiology Today’s Intervention has compiled a list of four recent updates relevant to devices for cardiac and vascular intervention.

FDA approves next-generation device for transcatheter mitral valve repair

Abbott announced that the FDA has approved a next-generation version of its transcatheter MitraClip device for the treatment of patients with mitral regurgitation. The catheter-based system features advanced navigation, steering and position capabilities for operators to navigate through difficult anatomies. Read more

FDA permits marketing of first catheter-based systems for vascular access for patients on hemodialysis

The FDA has granted marketing authorization for the use of the Ellipsys Vascular Access System (Avenu Medical) and the everlinQ endoAVF System (TVA Medical Inc.) to make percutaneous arteriovenous fistulas for patients with chronic kidney disease who are on hemodialysis. Read more

FDA issues safety alert for endovascular AAA graft system

A new FDA safety alert concerns risk for type III endoleaks with an endovascular abdominal aortic aneurysm graft device (AFX with Strata, Endologix). According to the safety alert, the risk for type III endoleaks is higher with this device compared with other endovascular AAA graft devices. Read more

FDA approves DCB in larger sizes for treatment of long lesions in PAD

Medtronic announced that the FDA approved longer lengths of its IN.PACT Admiral drug-coated balloon for treatment of long superficial femoral artery lesions in patients with peripheral artery disease. Read more