InterValve gets 510(k) clearance for catheter

Candace Stuart | | Cardiovascular Business | Structural Heart Disease

The FDA granted 510(k) clearance to InterValve to market its V8 Aortic Valvuloplasty Balloon Catheter.

The catheter is designed to be used in stand-alone balloon aortic valvuloplasty and predilation during transcatheter aortic valve replacement  procedures. In summary documents to the FDA, the company described the system as an hourglass-shaped balloon intended to allow for full dilation of stenotic aortic valve leaflets while minimizing over-dilation of the aortic annulus.

Minneapolis-based InterValve wrote that the balloon will be available in four diameter sizes, 22 mm through 28 mm, with a catheter available in working lengths of 107 cm and 113 cm compatible with a 12F or 14F introducer sheath. It is introduced through the femoral artery.

Candace Stuart, Contributor

Related Content

CMS proposes Medicare coverage for transcatheter tricuspid valve replacement
Hydra TAVR valve gains key approval as global reach continues to grow
SAVR outperforms TAVR in patients with bicuspid aortic valves
Treating AFib patients with TAVR still linked to elevated risks
Heart surgeons detail world’s first robotic heart procedure of its kind
Years of progress have made TAVR more effective when treating concomitant mitral stenosis

Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.