FDA nod for Omniwave thrombus removing technology:
This article was originally published in Clinica
Omnisonics Medical Technologies has received 510(k) clearance from the US FDA for its thrombus-removing OmniWave Endovascular System. The catheter-based system is used for the infusion of specific liquids, including thrombolytics, and to eradicate thrombi in the peripheral vasculature. It works by delivering low-power, transverse ultrasonic energy to remove thrombus "quickly, safely and effectively", said the Wilmington, Massachusetts firm. Thrombi are a common problem, with deep vein thrombosis (DVT) affecting approximately two million people in the US each year, and acute limb ischaemia affecting some 250,000. The OmniWave technology has been available in Europe since 2002.