Laplace treats its first three patients in a randomized tricuspid valve replacement trial

MedDevice Startups Staff · Oct 29 · 2 min read · Via Laplace Interventional release

Laplace Interventional has treated the first three randomized patients in TRIUMPH, a multicenter IDE study of its transcatheter tricuspid valve replacement system. The trial randomizes patients 2 to 1 against a commercially available TTVR device. Laplace did not name the comparator or state the planned enrollment.

Ballad Health in Kingsport, Tennessee treated one of the first patients under interventional cardiologist Gaurav Rana. Oklahoma Heart Institute in Tulsa treated another under Kamran Muhammad, who runs its structural heart program. Charanjit Rihal of Mayo Clinic, Kashish Goel of Vanderbilt University Medical Center and Brandon Jones of Providence St. Vincent Medical Center are the global principal investigators.

The prosthetic valve goes in through a vein in the neck or the groin. Laplace, based in Plymouth, Minnesota, puts the US population it is aiming at above 1.6 million tricuspid regurgitation patients. Goel is scheduled to present one-year data from the trans-jugular early feasibility study at TCT 2026 on November 2. The device is investigational and is not available commercially anywhere.

Randomizing against a device already on the market, instead of against medical therapy, is the harder road for a company this size. It also produces the comparison that interventionalists will actually ask about.

Questions & Answers

What is the Laplace Interventional TRIUMPH trial?

TRIUMPH is Laplace Interventional's prospective, multicenter IDE study of its transcatheter tricuspid valve replacement system. It randomizes patients 2 to 1 against a commercially available TTVR device. The first three randomized patients had been treated as of October 29, 2026.

Where did Laplace Interventional treat the first TRIUMPH patients?

Ballad Health in Kingsport, Tennessee treated a first patient under interventional cardiologist Gaurav Rana, and Oklahoma Heart Institute in Tulsa treated another under Kamran Muhammad, director of its structural heart program.

Is the Laplace Interventional tricuspid valve approved by FDA?

No. Laplace Interventional's transcatheter tricuspid valve replacement system is investigational and is not commercially available in the United States or elsewhere. TRIUMPH is being run under an FDA investigational device exemption.

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