A cardiac surgery and heart failure team at the University of Michigan has successfully implanted a novel mechanical heart pump in their first patient, marking a significant milestone in the INNOVATE clinical trial. The study aims to evaluate a potential alternative to the currently monopolized market for end-stage heart failure treatment devices.
The trial, formally titled "Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failure," introduces the BrioVAD, developed by BrioHealth Solutions, Inc., as a challenger to Abbott's HeartMate 3, which currently stands as the only FDA-approved device for both short- and long-term treatment.
Critical Need for Alternative Treatment Options
"Having only one device on the market for any condition is not ideal for patients," emphasizes Dr. Abbas Bitar, principal site investigator and clinical assistant professor of internal medicine-cardiology at U-M Medical School. "If a malfunction or supply chain issue were to arise, patients would be left without an option."
The urgency for alternative treatments is underscored by the significant patient population affected by heart failure. Among the 6 million Americans with heart failure, thousands await heart transplants or are ineligible for transplantation, making ventricular assist devices (VADs) a crucial therapeutic option.
Technical Innovations and Design Improvements
The BrioVAD incorporates several notable design improvements while maintaining the core magnetic levitation technology used in the HeartMate 3. Key features include:
- 20% smaller pump size compared to HeartMate 3
- Narrower driveline cable
- Lower rotor spinning speed to potentially reduce blood damage
- Single-battery system providing up to 12 hours of power
Trial Design and Patient Criteria
The INNOVATE trial employs a randomized design where:
- Two-thirds of participants will receive the BrioVAD
- One-third will receive the HeartMate 3
- Eligible patients must have left ventricular ejection fraction of 25% or less
- Participants must show worsening heart failure despite optimal medical therapy
Dr. Francis Pagani, national lead investigator and cardiac surgeon at the U-M Health Frankel Cardiovascular Center, notes, "This trial presents an opportunity to assess novel technology as we explore a potential new treatment for advanced heart failure - a life-threatening condition with extremely limited therapeutic opportunities available."
Current Market Context and Safety Considerations
The trial's timing is particularly relevant given recent developments in the VAD market. Abbott announced plans to discontinue its HeartMate II device by 2026, and in April 2024, both HeartMate models faced FDA recalls due to potential biological material buildup causing pump blockages.
Despite these challenges, Dr. Pagani acknowledges HeartMate 3's strong track record: "HeartMate 3 has achieved the best outcomes to date for patients with no other option for treatment and has set new, higher standards of patient outcomes to compare to all future devices."
The INNOVATE trial aims to expand to 40 U.S. health systems with a target enrollment of 780 participants. Dr. Robert B. Hawkins, assistant professor of cardiac surgery at U-M Medical School, expresses optimism about the trial's potential impact: "We look forward to assessing this new technology head-to-head with the current standard, in hopes of improving lives for patients across the country."
