Medtronic gets approval for CRT system labelling

Medtronic, the US-based medical technology company, has announced that the Food and Drug Administration (FDA) has approved expanded labelling for the company’s cardiac resynchronisation therapy (CRT) biventricular pacing systems.

The changes to the labelling include further description and explanation of the clinical benefits of the system, including reduced mortality rates and improved quality of life and exercise capacity.

“This is great news and absolutely appropriate given the overwhelming evidence in support of CRT therapy,” said Dr William T Abraham, director of the Division of Cardiovascular Medicine at the Ohio State University Medical Centre.

“The revised labelling, which considered the CARE-HF data, provides further validation that CRT and CRT defibrillator systems should be routinely used in patients with moderate to severe heart failure.”

According to Medtronic, the CARE-HF (cardiac resynchronisation in heart failure) study proved, in accordance with previous trials, that CRT reduces hospitalisation and saves lives in patients with certain levels of heart failure.

Dr David M Steinhaus, medical director of Medtronic Cardiac Rhythm Management, declared the company “extremely pleased” with the FDA decision.

© Adfero Ltd