PASCAL Gets US Approval; China Authorizes Asundexian

Edwards Lifesciences’ PASCAL Precision system has received US Food and Drug Administration approval for tricuspid valve repair, according to the company’s October 21, 2026, announcement. Separately, Bayer’s October 26 announcement confirmed Chinese marketing authorization for asundexian, a medicine to reduce stroke risk in a specified group of adults.

According to Bayer, China’s National Medical Products Administration authorized asundexian under the brand Sunharbo at a once-daily dose of 50 mg. The authorization covers adults following either an ischemic stroke of non-cardioembolic origin or a transient ischemic attack classified as high risk.

Bayer said asundexian selectively inhibits factor XIa, or FXIa. The company describes this blood-coagulation protein as participating in clot formation, with less involvement in producing the plug that closes an injured blood vessel.

The Chinese decision followed priority-review designation, with the global Phase III OCEANIC-STROKE trial providing the basis for authorization, according to Bayer. That study randomly assigned 12,327 participants. Bayer said the group receiving 50 mg of asundexian alongside either one or two antiplatelet therapies had 26% fewer ischemic strokes than the group receiving antiplatelet treatment alone. Overall bleeding-event incidence was similar across the groups, the company said.

The regulatory process included acceptance of Bayer’s marketing application by China’s Center of Drug Evaluation on April 29, 2026, according to the company. That application concerned prevention of ischemic stroke following a non-cardioembolic ischemic stroke or transient ischemic attack. Bayer said applications elsewhere remained under review as of its October 26 announcement.

For PASCAL Precision, Edwards said the approved use concerns patients whose severe tricuspid regurgitation remains symptomatic despite optimal medical treatment. The company described the indication’s purpose as improving patients’ quality of life and functional status, subject to surgical-risk and treatment-suitability requirements.

According to Edwards, patients must have at least an intermediate level of surgical risk. A heart team involving multiple disciplines must also determine that they are suitable for transcatheter edge-to-edge repair of the tricuspid valve, known as T-TEER.

FDA records place the system’s earlier authorization in mitral valve repair. The agency’s original approval in 2022 described use in selected patients with degenerative mitral regurgitation causing symptoms, where the risk associated with mitral surgery was prohibitive.

* This article is based on publicly available information at the time of writing.