FDA Breakthrough Device designation is granted to medical devices that have the potential to provide more effective treatment of life-threatening conditions or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these novel medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval.
"Receiving Breakthrough Device designation from the FDA underscores the significant unmet need for more effective treatment options for heart failure patients," commented George Fazio, president and CEO of Corvia Medical. "We look forward to continuing our work with the FDA through our ongoing pivotal trial in more than 100 hospitals, and providing the clinical evidence which will accelerate the timeline to bring the IASD to the US market."
The IASD is designed to provide continuous and dynamic decompression of the left atrium, which may reduce symptoms and slow the progression of heart failure. The device is being studied in Reduce LAP-HF II, a large multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients in the United States, European Union, Australia, Japan, and Canada.
"The FDA program should accelerate market access and adoption of novel treatments for heart failure patients in the U.S.," commented Kate Stohlman, VP of Quality and Regulatory Affairs for the company. "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."