Medtronic, Inc. (MDT) announced positive results from its REVERSE trial, which was designed to evaluate the effectiveness of cardiac resynchronization therapy (CRT) in mildly symptomatic or asymptomatic patients — that is, those with mild heart failure or patients who previously had heart failure symptoms, respectively.

The trial enrolled 610 patients and the 24-month data was presented from the European cohort of the study. Initial results for the 12-month period presented earlier were disappointing — the trial failed to meet statistical significance in its primary endpoint.

However, the 24-month data proved successful in meeting the end points. At present, CRT is not approved in the U.S. for the treatment of symptomatic or asymptomatic patients. It is used only for patients with moderate to severe heart failure.

The major findings in the REVERSE trial (24-month) are as follows:  

  • In NYHA Class II patients, CRT reduced the need for heart failure hospitalization.
  • There was a significant reduction in heart size, which helps the heart pump more efficiently in patients receiving CRT.
  • There was a significant increase in LVEF (left ventricular ejection fraction) – from 28.1% to 34.8% in patients receiving CRT, versus 27.8% to 29.9% in patients not receiving CRT.
  • CRT lowered left ventricular volumes throughout the range of QRS duration, the length of time required for the heart to contract. It was seen that the CRT effectiveness increased as QRS duration widened. 

We think that positive results from the REVERSE trial will widen Medtronic’s customer base and will increase its top-line. Medtronic is one of the world’s leading medical technology companies, specializing in implantable and interventional therapy devices and products.

The company’s main competitors include St. Jude Medical (STJ) and Boston Scientific Corporation (BSX). Based on the company’s first quarter of fiscal 2010 results, we have assigned an ‘Outperform’ rating for the company’s stock.

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