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October 8, 2019

Corvia Medical's IASD Receives FDA Breakthrough Device Designation for Heart Failure

October 9, 2019—Corvia Medical, Inc. announced that the FDA has granted the company a Breakthrough Device designation for its interatrial shunt device (IASD) for heart failure. The IASD is a transcatheter device for heart failure with preserved ejection fraction (HFpEF) and heart failure with midrange ejection fraction (HFmrEF).

According to the company, 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 multinational prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients in the United States, European Union, Australia, Japan, and Canada. Recruitment is ongoing.

Corvia Medical stated that receiving Breakthrough Device designation underscores the significant unmet need for more effective treatment. Corvia is working with the FDA as it conducts the ongoing pivotal trial for the IASD in more than 100 hospitals to provide the clinical evidence to support regulatory approval to bring the IASD to the United States market. The IASD is an investigational device and not available for commercial distribution in the United States.

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 health care 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.

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October 9, 2019

Medtronic's Field Action for 6-F Sherpa NX Delivery Catheter Classified by FDA as Class I Recall

October 9, 2019

Medtronic's Field Action for 6-F Sherpa NX Delivery Catheter Classified by FDA as Class I Recall