LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae

LivaNova (NSDQ:LIVN) said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae.

The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles.

Optiflow Arterial cannulae have a “basket tip with large openings,” LivaNova reported, which has been shown to significantly reduce wall shear stress and turbulence. This feature could help lessen ischemic complications from extracorporeal circulation during cardiac surgery, the company said.

“The sandblasting effect of conventional arterial ECC cannulae can result in endothelial damage and plaque mobilization, and arterial embolization of atherosclerotic plaques during ECC surgery frequently results in severe complications such as stroke or ischemia of other organs,” Dr. Alexander Assmann, from the Heinrich Heine University, said in prepared remarks. “The remarkable decrease in wall shear stress profiles and turbulence using dispersive cannula tips presents surgeons with the opportunity to reduce risk and improve outcomes when ECC is employed during cardiac surgery.”

“Built on a foundation of demonstrated hydrodynamic performance improvement, LivaNova is pleased to achieve FDA clearance and launch of the Optiflow Arterial cannulae family in the U.S.,” Alistair Simpson, GM of LivaNova’s cardiac surgery business, added.

“We look forward to its quick adoption and further validation of its effectiveness in reducing the risk of cardiac surgery complications due to arterial embolization. The successful launch of the Optiflow Arterial cannulae family demonstrates our commitment to delivering cardiac surgery treatments that optimize the surgeon’s ability to deliver the best care possible to patients.”

See the best minds in medtech live at DeviceTalks Boston on Oct. 2. 

The post LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae appeared first on MassDevice.

from MassDevice http://ift.tt/2yCn4eT