Neovasc Tiara

Neovasc Tiara is a transcatheter mitral valve replacement (TMVR) product brand developed by Neovasc Inc., a medical device company based in Richmond, British Columbia, Canada. The Tiara valve is designed to treat mitral regurgitation and other mitral valve disorders without open-heart surgery, delivered through a minimally invasive transapical or transcatheter approach. It is one of the flagship pipeline products of Neovasc, alongside its refractory angina treatment, the Neovasc Reducer. The Tiara system consists of a self-expanding nitinol frame with a biological tissue valve, engineered to anchor in the native mitral annulus and address the complex anatomy of the mitral valve. It is intended for patients who are at high risk for conventional surgical mitral valve replacement or repair. The device has undergone clinical investigation through early feasibility studies and CE Mark clinical trials in Canada and Europe. Neovasc Inc. is a publicly traded medical device company listed on the Toronto Stock Exchange and NASDAQ under the ticker NVCN. The company has faced significant financial and legal challenges, including patent litigation with Edwards Lifesciences over the Tiara technology, which resulted in a large damages award and contributed to financial restructuring. In 2022, Neovasc was acquired by Shockwave Medical, a California-based intravascular lithotripsy company, in an all-stock transaction valued at approximately US$100 million. Following the acquisition, the Tiara program continued under Shockwave Medical's portfolio. The Tiara brand represents a specialized, high-technology medical device addressing a significant unmet clinical need in structural heart disease. Its development reflects the broader trend of transcatheter therapies replacing surgical interventions for valve disease.

Neovasc Tiara was developed by Neovasc Inc., a Canadian medical device company headquartered in Richmond, British Columbia. Neovasc was originally founded as a spin-off from a larger medical device organization and focused on developing minimally invasive cardiovascular technologies. The Tiara transcatheter mitral valve replacement system emerged as one of the company's flagship programs, targeting the large and growing market for transcatheter mitral valve therapies. The Tiara device was designed to address mitral regurgitation through a transapical delivery approach, using a self-expanding frame that anchors in the mitral annulus. Early clinical work included first-in-human implants and feasibility studies conducted in Canada and Europe. The company pursued CE Mark approval pathways and engaged in clinical trials to demonstrate safety and efficacy. A major turning point came with patent litigation initiated by Edwards Lifesciences, which alleged that the Tiara technology infringed on its patents. In 2019, a jury in the United States found in favor of Edwards Lifesciences and awarded significant damages against Neovasc. This litigation created substantial financial pressure on the company and affected its ability to fund the Tiara program independently. Despite these challenges, Neovasc continued to develop the Tiara platform and reported progress in clinical studies. In January 2022, Shockwave Medical, Inc., a publicly traded company focused on intravascular lithotripsy, announced an agreement to acquire Neovasc in an all-stock transaction valued at approximately US$100 million. The acquisition was completed in 2022, and Neovasc became a subsidiary of Shockwave Medical. The Tiara program was integrated into Shockwave's broader portfolio of cardiovascular devices. The Tiara brand remains associated with the transcatheter mitral valve replacement technology originally pioneered by Neovasc, representing a significant innovation in structural heart intervention.

• Neovasc Inc. develops the Tiara transcatheter mitral valve replacement system.

• First-in-human implants and early feasibility studies conducted in Canada and Europe.

• 2019: U.S. jury rules in favor of Edwards Lifesciences in patent litigation against Neovasc over Tiara technology.

• January 2022: Shockwave Medical announces agreement to acquire Neovasc in an all-stock transaction valued at approximately US$100 million.

• 2022: Acquisition completed; Neovasc becomes a subsidiary of Shockwave Medical.

High-technology, minimally invasive structural heart device for high-risk mitral valve patients.

• Neovasc Tiara Transcatheter Mitral Valve Replacement System

  A self-expanding nitinol frame with a biological tissue valve, delivered transapically to treat mitral regurgitation.

1. 1Neovasc Tiara (Canada) - Wikidatawikidata.org
2. 2Neovasc Tiara product pageneovasc.com