TriClip G4 System – P230007
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: TriClip G4 System
PMA Applicant: Abbott Medical
Address: 177 Country Road B East, Saint Paul, MN 55117
Approval Date: April 01, 2024
Approval Letter: Approval Order
What is it?
The TriClip G4 System is used to treat tricuspid regurgitation (leaky tricuspid valve) often caused by an enlarged heart or damaged tricuspid valve leaflets, without open-heart surgery. The TriClip includes a clip placed into the body, a delivery catheter, and accessories. The clip implant has arms that open and close, allowing them to attach to the flaps of the tricuspid valve of the heart (leaflets).
The tricuspid valve is one of four valves of the heart that allows blood to flow from the right atrium (upper right chamber) to the right ventricle (lower right chamber) and prevents blood from flowing backward between the two heart chambers. A doctor inserts the catheter with the clip attached through the largest vein in the groin and pushes it forward to reach the tricuspid valve. The clip’s arms are used to grip the tricuspid valve leaflets and bring them together to narrow the space and reduce the leakiness of the tricuspid valve defect. When the clip is in the right position, it is released from the delivery catheter and the catheter is removed.
If the leakiness is not reduced enough with one clip, multiple clips may be implanted to minimize the leak. Once the clip or clips are in place, the tricuspid valve forces blood to flow in the correct direction within the heart.
The TriClip G4 system should only be used in people with a severe leaky tricuspid valve in who or whom:
- Are at intermediate or greater risk from traditional open-heart surgery
- The device can reduce the leakiness of the tricuspid valve to moderate or less
The TriClip device reduces the amount of blood that moves in the wrong direction through the tricuspid valve. In a clinical study comparing the results of 175 patients treated with the TriClip device and medicine and 175 patients treated only with medicine, two in 100 people treated with the TriClip device experienced a major safety complication within 30 days of the procedure, including:
- Death from a heart-related cause
- New kidney failure
- Infection
- Need for surgery
Eighty-eight in 100 people treated with the TriClip device had their tricuspid regurgitation reduced to moderate or less after one year and were twice as likely to experience success, compared to eight in 100 people treated with medicine alone. Successful reduction means people had an improved quality of life and relief of or fewer symptoms, such as tiredness, shortness of breath, or fatigue.
The TriClip G4 System should not be used in people who:
- Cannot take certain blood thinners used during or after the procedure
- Have an untreatable allergy to nickel or titanium
- Have an active infection in the heart or elsewhere in the body