CroíValve’s Duo takes a unique approach for treating tricuspid regurgitation

The Duo tricuspid valve device [Image courtesy of CroíValve]

CroíValve is making inroads in the tricuspid regurgitation (TR) treatment market currently occupied by Abbott and Edwards.

In February 2024, Edwards’ Evoque tricuspid valve became the first TR treatment to win FDA approval, followed by Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system in April.

Edwards designed its device to replace the native heart valve, while Abbott designed its TEER system to repair it.

CroíValve’s investigational Duo tricuspid coaptation valve system is different, with an approach that CEO Lucy O’Keeffe calls “the best of both worlds.”

O’Keeffe, who comes from an engineering background, was working on early TAVR programs at Medtronic when she met CroíValve co-founder Dr. Martin Quinn, the cardiologist who placed the first transcatheter aortic valve replacement (TAVR) implant in Ireland.<…

Read more
  • 0

CroíValve is set to challenge as tricuspid regurgitation treatment space heats up

The Duo tricuspid valve device. [Image courtesy of CroíValve]With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way.

Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an FDA nod. With Edwards’ device designed to replace the native valve and Abbott’s designed to repair it, CroíValve’s investigational Duo tricuspid coaptation valve system could bring the best of both to the table.

“We’re seen as sort of the best of both worlds,” CEO Lucy O’Keeffe told MassDevice in an interview.

Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is anchored in a novel way — it …

Read more
  • 0

CroíValve wins FDA IDE for tricuspid heart valve

The Duo heart valve repair device. [Image from the CroíValve website]CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system.

The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR).

Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is secured using a novel anchor system. This anchor system leaves the right heart and native valve apparatus untouched.

Dublin, Ireland-based CroíValve designed the straightforward implant procedure to suit a broad patient cohort. It uses standard imaging and accommodates the large anatomical variability seen in the target patient population. The companyR…

Read more
  • 0

CroíValve raises more than $9M in Series A round

CroíValve this week announced that it raised €8 million ($9 million) in a Series A fundraising round to support a feasibility clinical study of its tricuspid valve system.

The Dublin-baed company designed its Duo coaptation valve system to treat tricuspid regurgitation (TR), which is a severe heart condition that occurs when the tricuspid valve fails to close properly. The condition results in blood being pumped back into the right atrium and venous system.

CroíValve designed the Duo system with a computation valve implant that works with the native tricuspid valve to restore function. It is delivered percutaneously and is secured using an anchor system that avoids the right heart chamber and native valve apparatus.

Duo is implanted using standard imaging for a broad range of patients. CroíValve said the device’s approach has already “generated convincing pre-clinical and clinical data” and that temporary clinical implants have shown to…

Read more
  • 0