Ekos (Bothell, Washington) reported that the FDA has cleared its EkoSonic Endovascular System for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism (PE). Ekos said its ultrasonic devices are designed to "gently accelerate" the penetration of thrombolytic agents into thrombus, providing high levels of lysis.
A six-year patent war between Edwards Lifesciences (Irvine, California) and Medtronic (Minneapolis) has ended in a settlement that will require Medtronic to pay Edwards $750 million plus quarterly license royalty payments through April 2022. The agreement, reported Tuesday morning, was reached about a month after a Federal District Court ordered a preliminary injunction on U.S. sales of Medtronic's CoreValve transcatheter aortic valve replacement (TAVR/TAVI) system.
ALung Technologies (Pittsburgh) said it has closed on a new financing of about $10 million from new and existing investors. The proceeds will primarily support ongoing commercialization of the company's Hemolung respiratory assist system (RAS), a low-flow, minimally invasive ECO2R system.
Boston Scientific (Natick, Massachusetts) made a move to significantly expand its portfolio of devices for peripheral inteventions by agreeing to acquire the interventional division of Bayer (Leverkusen, Germany) for $415 million in cash. Bayer Interventional is based near Minneapolis.
Change is what the American public was promised (or some might say threatened with) during the 2008 presidential election and for better or worse, the healthcare industry worldwide has been served an extra large helping of that change over the past six years. While the medical device industry’s palate has reacted to most of that change the way a five-year-old reacts to Brussels sprouts, this year’s menu does appear to be more appetizing. In March, two competing companies filed IPO papers on the same day. TriVascular Technologies and Lombard Medical Technologies both sell devices to treat abdominal aortic aneurysms. TriVascular...
St. Jude Medical (St. Paul, Minnesota) reported the first patient implants in the Portico Re-sheathable Transcatheter Aortic Valve System U.S. investigational device exemption (IDE) trial (PORTICO trial). The trial is evaluating the Portico transcatheter aortic valve system, an aortic heart valve designed to be repositionable until fully deployed. The trial will enroll patients who are considered to have a high or an extreme surgical risk, meaning they would not be considered for open-heart surgery.