Edwards Lifesciences has invested $35 million for an exclusive right to acquire Corvia Medical, which is engaged in a U.S. pivotal trial for its InterAtrial Shunt Device (IASD) to treat heart failure.
The IASD provides continuous decompression of the left atrium, which may reduce symptoms and slow the progression of heart failure, according to Edwards. It is also the first transcatheter device designed to treat heart failure with preserved or midrange ejection fraction, the companies stated.
The device received CE mark approval in 2016, and the investment from Edwards will help Corvia complete the REDUCE LAP-HF II pivotal trial for seeking regulatory approval through the FDA.
"We are extremely pleased to have the support of the global leader in patient-focused innovations for structural heart disease as we continue to advance this novel treatment for heart failure," George Fazio, president and CEO of Corvia Medical, said in a press release. "We are proud of our accomplishments to date and look forward to completing the pivotal study with the support of our global clinical investigators."
In a separate transaction, Edwards acquired assets of Mitralign, a developer of an investigational transcatheter annuloplasty system to treat functional mitral and tricuspid regurgitation.
The assets include intellectual property as well as clinical and regulatory experience, according to Edwards. Additional details of the transaction weren’t disclosed.
Edwards holds 55 percent of the $4 billion market for transcatheter treatments of the aortic and mitral valves, according to a recent industry analysis. It is the major player in the TAVR space but lags behind Abbott in the growing transcatheter mitral valve repair (TMVR) space.
Like the other major device companies, Edwards is acquiring smaller companies and making strategic investments within the TAVR/TMVR sector, which is projected to double to $8 billion by 2023.