FDA approves Abbott’s sensor-enabled flexible ablation catheter

Abbott announced U.S. Food and Drug Administration (FDA) approval of the FlexAbility™ Ablation Catheter, Sensor Enabled™ designed to improve the versatility and precision during cardiac ablation procedures to treat atrial flutter, a type of irregular heartbeat. With the approval, the company has further expanded its electrophysiology portfolio for treating patients … Continue reading

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FDA approves vessel dilatation device in cardiovascular disease interventions

Cagent Vascular announces FDA 510(k) Clearance of its lead product, the Serranator™ Alto PTA Serration Balloon Catheter.  The Serranator™ is the first of a family of peripheral artery disease (PAD) technologies under development which incorporate proprietary Serration Technology to an angioplasty balloon.

“A new approach to vessel dilatation is long overdue … Continue reading

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St. Jude Launches New PressureWire X Guidewire for Complex Anatomies Patients

St. Jude Medical announced the U.S. clearance and launch of the company’s new PressureWire™ X Guidewire fractional flow reserve (FFR) measurement system. The latest generation of the pioneering PressureWire™ Guidewire system is designed to offer improved shapeability and better shape retention aimed at reducing vessel trauma, with the accuracy and … Continue reading

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New sheath provides exceptional access to challenging anatomies and branch vessels

W. L. Gore & Associates, Inc. announced the commercial availability of the GORE® DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the U.S., Europe, Canada, and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating … Continue reading

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