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

Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
News | Cath Lab | December 18, 2019
December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S.
Gallery | Cath Lab | October 31, 2019
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Overlay Init