News | Structural Heart Occluders | November 02, 2016

St. Jude Medical Announces Landmark Stroke Data from RESPECT Trial

Final analysis of the RESPECT trial showed the Amplatzer PFO Occluder reduced risk of recurrent stroke by 45 percent over guideline-directed medical therapy alone

RESPECT trial, Amplatzer PFO Occluder, St. Jude Medical, TCT 2016

November 2, 2016 — St. Jude Medical Inc. announced the long-term data from RESPECT, a landmark trial, during a First Report session at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.

RESPECT, a clinical trial of nearly 1,000 patients diagnosed with patent foramen ovale (PFO), which is a small opening between the upper chambers of the heart, and cryptogenic stroke (stroke from an unknown cause), compared PFO closure to medical therapy alone. Final results demonstrated that after long-term follow-up (average of ~6 years), treatment with the St. Jude Medical Amplatzer PFO Occluder was more effective than medical therapy alone in reducing the risk for recurrent ischemic stroke by 45 percent.

“The final analysis revealed that PFO closure is an effective treatment option for young and middle-aged patients with PFO and stroke from an unknown cause who face lifelong risk for another stroke,” said neurologist David E. Thaler, M.D., of Tufts Medical Center in Boston and a RESPECT principal investigator. “RESPECT data also show that PFO closure with the Amplatzer PFO Occluder is safe and has a low risk of device or procedure-related complications. The device was more effective than medication alone in preventing another stroke.”

The device is designed to lower the risk of stroke by sealing off the hole between the left and right atria – the patent foramen ovale. Normally the foramen ovale, which is a small opening between the left and right atria, closes shortly after birth, but remains patent – or open – in approximately 25 percent of adults. Left untreated, a PFO could allow dangerous clots from the veins to pass from the right side of the heart to the left and travel up to the brain and potentially cause a stroke.

“The Amplatzer PFO Occluder procedure is minimally invasive; it is performed without an incision while the patient is sedated but still conscious,” said John D. Carroll, M.D., director of interventional cardiology at the Cardiac and Vascular Center at the University of Colorado Hospital. “Interventional cardiologists and neurologists in major North American medical centers have worked together for more than 13 years to determine if PFO closure substantially reduces the risk of recurrent stroke; the data show it does.”

These final analyses presented at TCT 2016, which include additional follow-up beyond those on which U.S. Food and Drug Administration (FDA) approval was based, support continued patient benefit over an average of approximately six years of follow-up. The Amplatzer PFO Occluder was recently approved by the FDA and is the only device approved in the United States for PFO closure to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

For more information: www.sjm.com

Related Content

News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
Subscribe Now