HeartMate® XVE LVAS for Destination Therapy

The HeartMate® XVE Left Ventricular Assist System (LVAS) is now FDA approved as a long-term permanent implant, called Destination Therapy. The XVE is an enhanced version of the HeartMate SNAP-VE device approved in November 2002 for use for Destination Therapy, i.e. LVAS support as an alternative to optimal medical therapy for end stage heart failure patients who are not eligible for cardiac transplantation.* That approval marked the first time that a LVAS has been approved to provide Destination Therapy support for these patients. While the HeartMate LVAS has been approved as a bridge to cardiac transplantation since 1994 and used in more than 4,100 patients worldwide, Destination Therapy offers a breakthrough treatment option for end stage heart failure patients.

The HeartMate XVE incorporates a number of significant improvements over earlier versions of the HeartMate VE and since its introduction some two years ago has performed very well in approximately 75 years of cumulative patient experience as a bridge-to-transplant. The device changes were designed to ease implantation, provide for longer and more reliable device life and improve end stage heart failure patient outcomes. According to clinicians, patients on the device have experienced a significantly lower rate of complications, with many types of incidents virtually eliminated.

Enhancements incorporated in the HeartMate XVE include a longer, smaller diameter and more flexible lead designed to improve patient comfort and provide more flexibility for surgeons to accommodate larger patients. In addition, a rotating tunneling "bullet" was added to ease implantation and facilitate tunneling of the driveline through the exit site on the patients. The HeartMate XVE also includes enhanced controller software designed to reduce pressure and wear on valves and bearings. A brand new enhancement just being introduced for the HeartMate XVE is the New Inflow Valve Conduit. Designed to improve durability and ease of use, this new inflow valve demonstrated up to six times as long cycle performance as the old inflow valve during in-vitro testing. (Data on file).

The HeartMate XVE reflects technological advances based on the device experience learned in the landmark REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) clinical trial. FDA approval of Destination Therapy was based on the results of that trial, which compared the experience of patients supported by the HeartMate SNAP-VE with those being treated with optimal medical management (OMM). The results of that trial demonstrated meaningful survival benefits and improved quality of life for patients supported by the device.

This section is designed to introduce Medical Professionals to Destination Therapy (DT) and to explain how it may benefit your heart failure patients.

• American Heart Association (AHA) announces the HeartMate VE LVAS as the 2nd most important medical advance in the treatment of heart disease in 2001.
  
  
• What is the Medical Community saying about the HeartMate for Destination Therapy
  
  
• Meet the Patients of REMATCH
  
  
• List of REMATCH hospitals
  
  
• Patient Selection and Management
  
  
• Reimbursement for HeartMate XVE LVAS
  
  
• HeartMate Destination Therapy Videos
  
  
• Frequently Asked Questions
  
  
• HeartMate XVE LVAS Instructions for Use
  
  

* NYHA Class IV patients with end stage heart failure who have received optimal medical therapy for at least 60 of the last 90 days, who have a life expectancy of less than two years, and who are not candidates for cardiac transplantation.

 

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