“If we can provide a 20% absolute difference in mortality [with HeartMate II], that would outdistance any medical therapy we have and it would be a tremendous change,” Dr. Miller said during the conference call.
Another notable result was the units' reliability, with only five devices needing removal and only two developing thrombosis. “That's incredible performance,” Dr. Miller said.
The much smaller size of the new model is another important factor. “You need one-seventh of the surgical dissection to create the pocket where the pump goes. That probably accounts for the reduced bleeding, and it's technically easier. My surgeons are looking forward to this.
“I don't honestly see any downside to the data. We saw a safety and efficacy profile that beat anything that's been published. We met the end point with success across the board,” Dr. Miller said.