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FDA approves St. Jude's PFO occlusion device for recurrent stroke risk reduction

MDBR Staff Writer Published 31 October 2016

St. Jude Medical has secured approval from the US Food and Drug Administration (FDA) for its new medical device indicated to reduce the risk of recurrent ischemic strokes in patients with a patent foramen ovale (PFO).

The PFO is a small opening between the upper chambers of the heart.

St. Jude's Amplatzer PFO Occluder, which is claimed to be the only FDA-approved device for PFO closure in the US, has been demonstrated to lower the risk of stroke by sealing the unwanted hole between the left and right chambers of the heart.

Physicians will run tests to evaluate underlying risk factors, when a person suffers an ischemic stroke with no initial attributable cause (cryptogenic stroke). The tests will enable to determine the presence of PFO in the patient.

According to the company, the PFO can potentially allow dangerous clots to pass from the right side of the heart to the left, travel up to the brain and cause a stroke.

The firm carried out an eight-year RESPECT trial to assess the safety and efficacy of the Amplatzer PFO occluder.

The study, which included one thousand patients diagnosed with both PFO and cryptogenic stroke, showed that the Amplatzer device reduced the risk of recurrent stroke by over half compared to standard medical treatment.

St. Jude Medical chief medical officer Dr Mark Carlson said: “The AMPLATZER PFO Occluder underscores St. Jude Medical’s commitment to advancing therapies designed to improve long term quality of life and reduce health care costs.

“The approval of the AMPLATZER PFO Occluder is an important step for patients living in fear of recurrent stroke as a result of a PFO, and offers physicians more options to help their patients make decisions that best fit their lives.”


Image: The Amplatzer PFO occluder is the only device approved in the US for PFO closure. Photo: courtesy of Business Wire.