- Corvia Medical received FDA's breakthrough device designation for its interatrial shunt device for heart failure, the company disclosed Wednesday. It describes the tech as the first transcatheter device for heart failure patients with preserved or mid-range ejection fraction.
- The Tewksbury, Massachusetts-based device maker's now-prioritized regulatory review could benefit structural heart specialist Edwards Lifesciences, which announced in March it invested $35 million for the exclusive right to acquire Corvia.
- Those funds are helping Corvia carry out a multinational randomized trial of the CE-marked device, which is designed to continuously decompress the left atrium, thereby slowing progression of heart failure, the company said.
A heart failure patient's ejection fraction measures how well the heart pumps blood with each beat. In an individual who does not have heart failure, or who has heart failure with preserved EF, that percentage might be in the range of 50% to 75%.
A patient whose heart pumps 40% to 50% of the blood in the left ventricle with each beat is described as having mid-range EF, a state of heart failure researchers writing in the European Journal of Heart Failure in 2014 likened to the neglected "middle child" of the disease state, pointing out its under-studied nature compared to other forms of the disease.
"Medicines that are effective for treating the other type of heart failure ... frequently do not work well for [heart failure with preserved EF] of [heart failure with mid-range EF] and treatment options are currently very limited," Corvia said Wednesday.
As with other devices singled out as offering more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions, the breakthrough device designation will afford Corvia access to FDA's help in expediting development, assessment, and review of the technology. FDA also designated an interatrial shunt for advanced heart failure from Israeli startup V-Wave in August.
In addition to investments from biotech VC firm Third Rock Ventures and Israel-based health tech funds AccelMed, Corvia's technology grabbed the attention of Edwards Lifesciences. Edwards sells transcatheter products for aortic valve replacement and mitral and tricuspid valve repair but appears to be seeking greater access to the 5.7 million American adults with some form of heart failure.
When the Edwards agreement was announced in March, Corvia said it would put those funds toward completing its pivotal REDUCE LAP-HF II clinical trial.
"Demonstrating reduced recurrent heart failure hospitalizations and improved quality of life for these patients, through rigorous clinical trials that generate real evidence, is the company's primary objective," Corvia VP of Quality and Regulatory Affairs Kate Stohlman said in a statement.