Corvia Medical's Atrial Shunt System Gains CE Certification in Europe
Corvia Medical's Atrial Shunt System Gains CE Certification
Corvia Medical, Inc. is making waves in the medical industry with the recent announcement that it has achieved CE certification for its Corvia® Atrial Shunt System. This certification represents a significant milestone for the company as it navigates the stringent requirements of the latest EU Medical Device Regulations (EU MDR 2017/745). The Atrial Shunt is a cutting-edge catheter-based cardiac implant aimed at improving heart failure treatment.
Understanding the Corvia Atrial Shunt System
The Corvia Atrial Shunt is designed specifically to alleviate the symptoms of heart failure (HF), a condition that affects over 26 million people around the globe. A particular challenge faced by many patients is heart failure with preserved ejection fraction (HFpEF). These individuals often experience comfort while resting but struggle with breathlessness upon any physical exertion.
How the Atrial Shunt Works
This innovative device addresses elevated left atrial pressure (LAP), which is a primary contributor to the distressing symptoms of heart failure. By creating a controlled passage between the left and right atria, the Corvia Atrial Shunt enables better management of fluid and pressure within the heart while helping to minimize symptoms experienced by patients.
RESPONDER-HF Clinical Trial
Corvia Medical is currently conducting the RESPONDER-HF clinical trial, which is a critical part of validating the effectiveness of the Atrial Shunt. In this randomized trial, approximately 70 study sites worldwide are enrolling heart failure patients who do not have underlying pulmonary vascular disease or pacemakers. Early results from previous studies have shown substantial clinical benefits, affirming the treatment's promise for patients.
The Impact of CE Certification
Achieving CE Mark certification for the Atrial Shunt is a testament to Corvia Medical's dedication to safety and clinical efficacy. Kate Stohlman, the VP of Quality and Regulatory Affairs at Corvia, expressed the pride she and her team feel about this accomplishment. "This approval reflects the dedication, commitment, and efforts of our entire global team to the highest levels of device safety and clinical performance," said Stohlman.
The Future of Heart Failure Treatment
As Corvia Medical strives to revolutionize heart failure treatment, the Atrial Shunt stands at the forefront of their innovative efforts. Founded in 2009 and headquartered in Tewksbury, MA, Corvia remains committed to transforming standards of care with advanced transcatheter cardiovascular devices.
About Corvia Medical, Inc.
The company has established a reputation for its groundbreaking designs, with the Atrial Shunt previously receiving Breakthrough Device designation from the FDA in 2019. Corvia's progress is supported by a range of notable investors, further emphasizing the trust and optimism surrounding its missions. Their focus continues to be on patient-centric innovations that empower individuals suffering from heart conditions to reclaim their lives.
Contact and More Information
For those interested in learning more about Corvia Medical's efforts and ongoing clinical trials, the company has made information readily available. Interested parties can reach out for physician referral and enrollment details regarding the RESPONDER-HF trial.
Frequently Asked Questions
What is the Corvia Atrial Shunt System?
The Corvia Atrial Shunt System is a catheter-based implant designed to alleviate symptoms of heart failure by reducing pressures in the heart and lungs.
What is the significance of CE certification?
CE certification under the EU MDR signifies that the Atrial Shunt System meets rigorous European safety and performance standards for medical devices.
How many patients are involved in the RESPONDER-HF trial?
Approximately 70 study sites worldwide are engaged in the RESPONDER-HF clinical trial, enrolling heart failure patients for evaluation.
What does the Atrial Shunt address specifically?
The device targets elevated left atrial pressure, which is a significant factor contributing to heart failure symptoms.
Who founded Corvia Medical?
Corvia Medical, Inc. was founded in 2009 and is driven by a mission to transform heart failure treatment through innovative cardiovascular devices.
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