On Tuesday, May 24, 2016, the Food and Drug Administration’s (FDA) Circulatory Systems Device Panel gathered to discuss and provide recommendations related to the premarket approval (PMA) application for St. Jude Medical’s AMPLATZER Patent Foramen Ovale (PFO) Occluder.
SCAI was the only society to provide testimony at the hearing on behalf of the interventional cardiovascular community and our patients. SCAI Structural Heart Disease (SHD) Committee Chair Clifford Kavinsky, MD, PhD, FSCAI testified that, at minimum, limited approval of a device for PFO closure with a multidisciplinary team approach, mandatory participation in a patient registry and specific operator and institutional requirements would lead to a safe and efficacious dissemination of percutaneous PFO technology to our patients and fulfill an important unmet need.
The panel voted 15-1 that the AMPLATZER is safe, 9-7-that it is effective and 11-5 that its benefits outweigh its risks. The FDA will take the panel votes and comments into consideration as they craft their final decision regarding approval in the coming months.
SCAI believes that there is an important unmet clinical need in patients with cryptogenic stroke and PFO beyond what conventional medical therapy currently offers. Although randomized controlled trials of PFO closure have had inherent and likely unavoidable design concerns, SCAI believes that young patients with cryptogenic stroke are particularly at risk and can significantly benefit from PFO closure. Careful patient selection will be important, as always, in determining appropriateness.
Catheterization and Cardiovascular Interventions has published a multi-disciplinary position paper and the American Heart Association and American Stroke Association have published guidelines regarding patients with PFO; both documents recommend PFO closure in at least some subsets of patients. The SCAI SHD Committee has also established a PFO working group, which will be developing guidance documents addressing patient selection and operator/institution experience recommendations.
I’d like to thank Dr. Kavinsky for lending his time to represent the Society in this effort to provide greater access to new therapies that benefit our patients.
Your insight on such matters is always invaluable. Please contact me at any time with your thoughts and concerns at president@SCAI.org.
Kenneth Rosenfield, MD, MHCDS, MSCAI
2016-17 SCAI President
Clifford Kavinsky, MD, PhD, FSCAI
SCAI Structural Heart Disease Committee Chair