Dive Brief:
- Abbott said Tuesday it has started a postmarket study to evaluate the real-world use of TriClip in repairing tricuspid heart valves.
- The Food and Drug Administration approved TriClip in 2024 based on results from a pivotal trial. Abbott has continued to add to the evidence on TriClip, including through recent registry data.
- Running the real-world study will allow Abbott to track outcomes in about 1,000 TriClip patients over five years, providing further evidence in a market targeted by rival Edwards Lifesciences.
Dive Insight:
Abbott won approval for TriClip, as well as the overwhelming support of an advisory committee, after showing the transcatheter edge-to-edge repair system reduced the severity of tricuspid regurgitation and drove quality-of-life improvements. Tricuspid regurgitation, or TR, happens when a leaky valve allows blood to flow backward, forcing the heart to work harder. The device clips flaps of tissue together to fix valves.
The new study will assess TriClip’s safety and performance in a contemporary, real-world setting. Abbott plans to work with up to 100 sites globally to enroll about 1,000 people and track them for five years. The trial’s three primary endpoints look at adverse events, TR severity and health status 30 days after treatment.
Tracking patients beyond the primary endpoint assessments will enable Abbott to uncover longer-term outcomes, including the effect of TriClip on the structure of the heart. The organ’s structure can change when it is injured or overloaded. An imaging sub-study of 250 patients will assess whether TriClip reverses those changes, which are known medically as cardiac remodeling, in the 12 months after treatment.
Abbott’s attempt to strengthen the evidence on TriClip comes ahead of anticipated competition in the U.S. market. Edwards expects to launch its Pascal treatment for tricuspid patients in the U.S. in the fourth quarter. The device already competes with TriClip for the European TR market.
Pascal features such as independent grasping “really make a difference” in tricuspid patients, Daveen Chopra, corporate vice president, transcatheter mitral and tricuspid therapies, surgical and implantable heart failure management at Edwards, said on the company’s earnings call last week. The features mean that physicians “want to use Pascal more and more often” in tricuspid patients in Europe, Chopra said.
The anticipated Pascal launch could pressure a successful part of Abbott’s structural heart unit. Abbott has been “showing good growth in tricuspid,” CEO Robert Ford said on an earnings call this month. The growth has offset challenges at the mitral business, an area where Abbott has “got to do a better job” following an increase in “competitive intensity” in the U.S., Ford said.
