MINNEAPOLIS, Minn., June 29, 2026
Laplace Interventional has reached a significant regulatory milestone after receiving U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its TRIUMPH pivotal clinical trial, evaluating the company’s innovative Transcatheter Tricuspid Valve Replacement (TTVR) System for patients with severe tricuspid regurgitation (TR). The IDE approval enables Laplace to begin a large multicenter pivotal study that will generate the clinical evidence required to evaluate the safety and effectiveness of its next-generation structural heart technology. The approval follows encouraging outcomes from the company’s Early Feasibility Study (EFS) and represents an important advancement in the development of minimally invasive treatment options for patients suffering from advanced tricuspid valve disease. With an estimated 1.6 million patients in the United States affected by tricuspid regurgitation, many of whom have limited therapeutic options, the TRIUMPH trial is expected to play a critical role in advancing transcatheter valve replacement technologies while addressing a significant unmet cardiovascular need.
TRIUMPH Trial to Evaluate Safety and Effectiveness of TTVR
The TRIUMPH study is designed as a prospective, multicenter pivotal clinical trial that will evaluate the safety and clinical performance of the Laplace Transcatheter Tricuspid Valve Replacement System in patients diagnosed with severe tricuspid regurgitation. The study plans to enroll approximately 400 patients across up to 75 clinical sites throughout the United States, using a 2:1 randomized design comparing the investigational Laplace device with commercially available transcatheter tricuspid valve replacement therapies.
In addition, the trial includes a single-arm registry of up to 150 patients who are either ineligible for commercially available TTVR systems or unsuitable candidates for transcatheter edge-to-edge repair, allowing researchers to evaluate treatment outcomes in a broader patient population with complex anatomical characteristics. The pivotal trial builds upon favorable safety and efficacy data generated during Laplace’s Early Feasibility Study, supporting the continued clinical development of the investigational device.
Leading Structural Heart Specialists Guide Global Study
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Laplace also announced the appointment of three internationally recognized structural heart experts as Global Principal Investigators for the TRIUMPH trial. The leadership team includes Dr. Charanjit Rihal of Mayo Clinic, Dr. Kashish Goel of Vanderbilt University Medical Center, and Dr. Brandon Jones of Providence St. Vincent Medical Center. These institutions served as the highest enrolling centers during the company’s U.S. Early Feasibility Study and have accumulated significant clinical experience using the investigational technology.
Investigators believe the unique design of the Laplace TTVR System may expand treatment eligibility for patients with challenging tricuspid valve anatomies while potentially improving procedural safety compared with currently available technologies. The collaboration between leading structural heart centers and Laplace is expected to accelerate the collection of high-quality clinical evidence needed to support future regulatory submissions and broader adoption of transcatheter tricuspid valve replacement therapy.
FDA Approval Advances Structural Heart Innovation
The FDA’s Investigational Device Exemption marks a major milestone in Laplace Interventional’s mission to develop innovative minimally invasive therapies for structural heart disease. Tricuspid regurgitation remains one of the most undertreated valvular heart conditions despite being associated with progressive heart failure, reduced quality of life, and increased mortality. As transcatheter valve technologies continue transforming cardiovascular care, the Laplace TTVR System has the potential to provide physicians with an additional treatment option for patients who are poor candidates for conventional open-heart surgery.
By advancing into pivotal clinical evaluation, the company moves one step closer to potentially delivering a next-generation transcatheter solution capable of improving outcomes for patients with severe tricuspid valve disease while further strengthening innovation within the rapidly evolving structural heart MedTech sector.
Source: Laplace Interventional press release
