The RESPECT Trial Final Results Demonstrated That After Long-term Follow-up (average Of ~6 Years), Treatment With The St. Jude Medical(TM) AMPLATZER(TM) PFO Occluder Was More Effective Than Medical Therapy Alone In Reducing The Risk For Recurrent Ischemic Stroke By 45 Percent. (Photo: Business Wire)
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the long-term data from RESPECT, a landmark trial, during a First Report session at the 2016 Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161101006374/en/
The RESPECT trial final results demonstrated that after long-term follow-up (average of ~6 years), treatment with the St. Jude Medical(TM) AMPLATZER(TM) PFO Occluder was more effective than medical therapy alone in reducing the risk for recurrent ischemic stroke by 45 percent. (Photo: Business Wire)
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 Dr. David E. Thaler 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 AMPLATZER PFO Occluder 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.