HeartWare International has initiated a voluntary field corrective action and started in-field repairs of certain controllers because a small number have exhibited reduced levels of speaker volume. The controllers are used in the HeartWare Left Ventricular Assist System, which is approved for use in Europe but is currently in clinical trials in the U.S. under an IDE, Mass High Tech reports.
The HeartWare controller manages the HVAD pump provides information to the patient and physician via visual and audio feedback. Last July, HeartWare revised its controller to incorporate waterproofing; however, during air transportation, a few developed excess air vacuum that subsequently reduced levels of speaker volume, the company says in a statement. No one has experienced any form of resultant medical complications, the company notes.
"The implementation of the waterproof controllers in July 2009 unfortunately generated an air-tight vacuum within our controller with the result that our speaker may be quieter than expected in a small number of cases, including just one occurrence in the U.S. since the commencement of implanting in our IDE trial in August 2008," says HeartWare President and CEO Doug Godshall. "We have since rectified this issue but there are still patients being supported by our now waterproof controllers that do not have the current 'vented' controller. This field program will enable these older versions to be upgraded to the current vented configuration. We will also take this opportunity to replace approximately 80 controllers which were introduced since we received our IDE for our U.S. bridge-to-transplant trial."
The aggregate cost of implementing this voluntary repair and replacement project is expected to be less than $400,000, inclusive of inventory, travel, freight and related costs, and this program is expected to be completed within 30-60 days. Wedbush analyst Duane Nash says in a note that the recall does not present a material risk to the company, even in the near-term, Reuters notes.
The partial recall comes as the company released positive data from an international clinical trial and from commercial use of its HVAD device showing a survival rate of 90 percent after six months. The data came from a 50-patient international study and from the first 50 commercial patients, Mass Device reports.