January 19, 2011 – GE Healthcare and Veran announced a strategic supplier agreement this week in which GE became the exclusive distributor and reseller of Veran’s ig4 fusion imaging angiography navigation system in the United States.


January 19, 2011 – The U.S. Food and Drug Administration (FDA) granted conditional approval to modify the CoreValve U.S. pivotal clinical trial to eliminate the medical management arm of the study.

January 19, 2011 – Stents can open up blocked brain arteries after other stroke treatments have failed, according to research presented this week at the 23rd annual International Symposium on Endovascular Therapy (ISET).

January 19, 2011 – Siemens Healthcare is partnering with Endosense for the integration of the contact-force data provided by Endosense’s TactiCath force-sensing ablation catheter with Siemens’ electrophysiology (EP) solutions.

January 18, 2011 – The first endovascular device approved for the treatment of pulmonary embolism (PE) was granted CE-mark approval this week in Europe. The Ekos EkoSonic Endovascular System was originally designed and approved to dissolve blood clots in the arms and legs.

January 19, 2011 – The U.S. Food and Drug Administration (FDA) this week granted market clearance for Cook Medical’s Formula balloon-expandable renal stent system. The approval includes both the Formula 414RX Renal and the Formula 418 Renal stents.

January 13, 2011 – A catheter that removes emboli and thrombi from vessels in the coronary and peripheral vasculature has received 510(k) clearance from the U.S. Food and Drug Administration. The Xpress-Way RX manual extraction catheter is manufactured by Kaneka Corp. and distributed by Atrium Medical in the United States.

January 13, 2011 – The first patients have been enrolled in a trial evaluating the effectiveness and safety of a force-sensing ablation catheter for treating symptomatic paroxysmal atrial fibrillation (AF). The TOCCASTAR trial will study Endosense’s TactiCath force-sensing ablation catheter.

January 13, 2011 – Enrollment has finished for the ORION trial designed to test the Epic self-expanding nitinol stent to treat iliac artery disease.

The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at nine months in 125 patients at 28 sites in the United States.

January 13, 2011 – HeartWare International has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for its ventricular assist system. The system acts as a bridge to heart transplantation for patients with end-stage heart failure.

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