Medtronic Initiates Device Implants under Largest CRT Trial
Minnesota-based medical device manufacturer Medtronic, Inc. (MDT) recently reported the first implants of cardiac resynchronization therapy (CRT) devices in heart failure patients as part of the AdaptResponse trial.
The primary objective of the clinical trial is to draw a comparison between cardiac patients implanted with CRT devices comprising the AdaptiveCRT software and those receiving conventional CRT. The study will be carried out on the basis of two endpoints – patient mortality rate and rate of hospitalizations for worsening heart failure.
A cardiac patient requires CRT when his/her heart develops arrhythmia or irregular heart rhythms. A CRT pacemaker emits small, undetectable pulses of electricity to the two lower chambers of the heart to help them beat together in a more synchronized pattern. Consequently, the heart's ability to pump blood and oxygen to the body improves.
Medtronic's pioneer AdaptiveCRT software, available in its Viva XT CRT-D (CRT devices with defibrillation), delivers customized physiologic pacing. This procedure works by maintaining normal heart rhythms and automatically adjusts it as per patients' requirements.
The primacy of the AdaptiveCRT algorithm will be evaluated in the AdaptResponse trial. Presumably, this is the largest CRT trial till date with enrollment tolling approximately 3,000 patients across the globe.
The trial will analyze if the enrolled patients suffer from atrial fibrillation (AF). Secondary endpoints involve measuring the cost efficiency of CRT devices with the AdaptiveCRT feature versus standard CRT devices.
Enrolled patients will be provided either a CRT-pacemaker or CRT-defibrillator incorporated with the AdaptiveCRT algorithm. A follow-up will be conducted on them at 3 and 6 months after surgery and thereafter, every 6 months until the end of the trial.
Patients will be enrolled at 200 centers in Europe, Latin America, the Middle East, Australia, Canada, India, Japan, South Korea, Taiwan and the U.S.
Medtronic presently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), Abaxis, Inc. (ABAX) and Conatus Pharmaceuticals Inc. (CNAT). While ICU Medical sports a Zacks Rank #1 (Strong Buy), both Abaxis and Conatus hold a Zacks Rank #2 (Buy) each.
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