News | November 07, 2006

Thoratec’s HeartMate II Trial Enrollment Advances

Thoratec has announced it has filed the first two modules of its Pre-Market Approval to market its HeartMate II for bridge-to-transplantation (BTT).

The company says that of October 26, 2006, it had implanted a total of 416 patients in its Phase II pivotal trial for the next generation assist device, enrolling 97 patients during the past three months, including a record 48 patients in the Destination Therapy arm.

The updated HeartMate II pivotal trial patient enrollment includes 220 patients enrolled in the BTT arm versus 171 three months ago, and 196 Destination Therapy (DT) patients versus 148 three months ago. Of the DT patients, 113 are enrolled in the randomized portion of the trial, which means the company is now more than halfway to the 200 patient enrollment called for in the DT arm of the trial.

The company recently completed two important transactions as part of its long-term growth strategy: (1.) A distribution agreement with Levitronix under which Thoratec will distribute the Levitronix CentriMag Blood Pumping System in the U.S. The device is used for short-term support of patients requiring extracorporeal circulatory support during cardiac surgery in the U.S. (2.) The company's ITC division acquired A-VOX Systems, a leading manufacturer of point-of-care (POC) instruments and disposables used in co-oximetry testing. This transaction increases ITC's presence in the hospital POC market, including the cath lab, operating room and intensive care unit.

Related Content

Roxwood Medical Announces Agreement With Abbott for U.S. Product Distribution
News | Catheters| August 09, 2017
Roxwood Medical Inc. recently announced it has entered into an exclusive agreement with Abbott for distribution of...
Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter
News | Chronic Total Occlusion (CTO)| June 28, 2017
June 28, 2017 — Royal Philips recently announced the relaunch of its Pioneer Plus...
Teleflex, FDA 510k clearance, TrapLiner Catheter, U.S. launch
Technology | Catheters| March 02, 2017
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
Technology | Radial Access| February 17, 2017
Medtronic plc announced that its coronary portfolio will now include the DxTerity Diagnostic Angiography Catheter line...
Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device
News | Peripheral Artery Disease (PAD)| February 15, 2017
Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented...
Sponsored Content | Videos | Guidewires| November 18, 2016
A discussion with guidewire expert Dimitri Karmpaliotis, M.D., Ph.D., FACC, about the basics of interventional guidew
Merit Medical Systems, SwiftNINJA Steerable Microcatheter, FDA 510(k) clearance
Technology | Catheters| November 09, 2016
November 9, 2016 — Merit Medical Systems Inc.
recall, alligator retrieval device, X-Celerator hydrophilic guidewire, UltraFlow flow directed micro catheters, Marathon flow directed micro catheters
News | Cath Lab| October 18, 2016
Medtronic plc announced last week that it has notified customers of a voluntary recall of certain lots of its Pipeline...
Terumo Finecross guidewire illustrates some of the basics of guide wire technology

An illustration of Terumo's Finecross guidewire crossing a tight lesion. 

Feature | Guidewires| October 12, 2016 | Dave Fornell
While guidewires are a key tool used by
Overlay Init