Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary system controller to their backup system controller.”
The company said that 8 of the 9 events “occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller….
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Physicians from three top institutions report an abrupt and highly troubling increase over the last two years in the incidence of pump thrombosis in patients who have received the HeartMate II left ventricular assist device (LVAD) manufactured by Thoractec.
The current investigation, published online in the New England Journal of Medicine, was initially prompted by an observed increase in pump thrombosis at the Cleveland Clinic. This first led to an analysis performed by INTERMACS (the Interagency Registry for Mechanically Assisted Circulatory Support) which found an increase from 2% before May 2011 to 5% afterwards. But, write the NEJM authors, there is reason to believe the INTERMACS analysis may have underestimated the rate of pump thrombosis. (The INTERMACS data, along with other papers about the problem, have been published in a special issue of the Journal of Heart and Lung Transplantation.)
The new paper is based on pooled data from 895 patient who received the HeartMate II LVAD at the Cleveland Clinic, Barnes-Jewish Hospital, and the Duke University Medical Center . The authors report that after March 2011 the incidence of confirmed pump thrombosis within three months of implantation increased from 2.2% to 8.4% by January 2013.
Click here to read the full story on Forbes.
The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year.
HeartWare was approved based on data from the pivotal ADVANCE trial, in which 140 patients received the Heartware device and were compared to historical controls who had received Thoratec’s HeartMate II device. The FDA said this was the first time it had approved an LVAD using registry data as a control. Unlike Thoratec’s HeartMate II VAS, which is surgically implanted in an abdominal pouch, the HeartWare VAS is implanted next to the heart.
The FDA said that surgical outcomes were comparable in the two groups. Because of the risk of stroke associated with the device, the FDA said patients and clinicians should “discuss all treatment options before deciding to use the device.”
HeartWare said that the FDA was requiring the company to perform a post-approval study in the form of a registry consisting of 600 HeartWare patients and an additional 600 control patients. The FDA will also require sites that implant the device to undergo training with an approved program.
Click here for the HeartWare press release.
Click here to read the FDA press release…
The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted 8-3 that the device was safe.
In briefing documents published online earlier in the week, FDA reviewers raised a number of questions about the safety of the device and the reliability of the data from the pivotal ADVANCE trial, in which 140 patients received the Heartware device and were compared to historical controls who had received Thoratec’s HeartMate II device. The FDA had not previously permitted historical controls to be used in this fashion. Safety questions focused on stroke and thrombosis.
Unlike the HeartMate II VAS, which is surgically implanted in an abdominal pouch, the HeartWare VAS is implanted next to the heart.
“I think this device is of incredible benefit to patients who are very ill,” said panelist Ralph Brindis, as reported by MedPage Today. Acting panel chair Rick Page said the device represented ”a real advance in technology,” as reported by Heartwire.
Click here to read the press release from HeartWare…