SentreHeart Inc. announced this week it has treated the first patients using the Eclipse Surgical Device, which is approved and CE Marked in Europe for left atrial appendage (LAA) closure. Krzysztof Bartus, M.D., Ph.D., and associate professor of the Jagiellonian University, Department of Cardiovascular and Transplant Surgery in Krakow, Poland performed the procedures.

3-D bioprinting, 3-D printing, printed organs, 3D bioprinting
3-D bioprinting, 3-D printing, printed organs

The U.S. Food and Drug Administration (FDA) changed its rules concerning custom medical devices Oct. 12, adding new definitions to better outline what constitutes a device that does not require premarket or 510(k) marketed clearances, or requirements for clinical trials to measure its efficacy or safety. The FDA also released a guidance document for manufacturers and FDA staff regarding these amendments. The FDA made the changes as these types of devices are being eyed for guidance in the creation of custom, one-off, 3-D printed medical devices. 

VIVA (Vascular Interventional Advances) Physicians announced a number of highly anticipated late-breaking clinical trial results at VIVA 16, hosted at the Wynn Las Vegas Sept. 18-22.

October 12, 2016 — The Society for Vascular Surgery (SVS) has released new reporting standards focused on endovascular treatment of chronic lower extremity peripheral artery disease (PAD). Recommended reporting standards for lower extremity ischemia were last published by the SVS in 1997.

Terumo Finecross guidewire illustrates some of the basics of guide wire technology

While guidewires are a key tool used by all interventionalists in the cath lab, most operators do not have a deep understanding of the basic technologies or definitions used for these devices. 

Medtronic plc announced recently that the U.S. Food and Drug Administration (FDA) has cleared the TrailBlazer angled support catheter for use in the peripheral vascular system. Support catheters such as the Trailblazer are often used in endovascular procedures treating complex peripheral artery disease (PAD).

Awards from the National Institutes of Health’s Common Fund are supporting research on the peripheral nervous system, in hopes of finding new ways to treat conditions such as asthma, diabetes and nausea. The new awards total more than $20 million in fiscal year 2016, and go to 27 multidisciplinary research teams through the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program. The SPARC program plans to support awards totaling approximately $238M through fiscal year 2021, pending available funds.

The U.S. Food and Drug Administration (FDA) has issued 510(K) Class II clearance to a web client for the AirStrip One mobile interoperability platform and application. The system can be run on desktops and laptops using Internet Explorer and Google Chrome.

October 10, 2016 — ZipLine Medical Inc. recently announced results from a study recently published online in Pacing and Clinical Electrophysiology (PACE) showing significant efficiencies when Zip Surgical Skin Closure is used following cardiac implantable electronic device (CIED) implantation. The Zip also demonstrated greater uniformity in closure technique, with no compromise in cosmetic outcomes or patient safety.

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