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The coexistence of a patent foramen ovale and obstructive sleep apnea may increase the risk of wake-up stroke in young adults.
CONCLUSIONS: These suggest that coexistence of PFO and OSA may associate with a greater risk of youth stroke. Decrease risk of stroke might occur if treating with CPAP in patients with OSA. PMID: 31045524 [PubMed - as supplied by publisher]
Source: Technology and Health Care - April 23, 2019 Category: Medical Devices Authors: Man H, Xu Y, Zhao Z, Zhang S, Lv R, Chi X, Li X, Zhang Z Tags: Technol Health Care Source Type: research

Amplatzer Patent Foramen Ovale Occluder: Safety and Efficacy.
Authors: Madhkour R, Wahl A, Praz F, Meier B Abstract INTRODUCTION: The patent foramen ovale (PFO) is a common anatomical variant in humans (prevalence 25%). Most often asymptomatic, it may engender paradoxically embolic strokes, myocardial infarctions, or visceral or peripheral ischemia. It is causatively related to migraine, positional or exertional hypoxemia with dyspnea, diving incidents, high altitude edema, and sleep apnea. Percutaneous closure of atrial septal defects was first performed in the seventies. A dedicated PFO occluder (Amplatzer PFO Occluder) was first used on September 10, 1997 by Kurt Amplatz a...
Source: Expert Review of Medical Devices - February 12, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Gore Takes on Abbott with New PFO Stroke Indication
W.L. Gore & Associates has received FDA approval to expand the indication of the Gore Cardioform Septal Occluder to reduce the risk of recurrent ischemic stroke in patients. The device treats patients through the closure of patent foramen ovale (PFO). Cardioform’s previous indication was for the closure of atrial septal defects that are up to 17mm in size. Gore’s Structural Heart Leader, Jake Goble said Cardioform has the potential to redefine stroke prevention. Goble began working for Gore in 2007. It was around that time the company began to explore the possibility of having the Cardioform focus on stroke prevent...
Source: MDDI - April 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients. The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy. “With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news

Transcatheters for Closure of Patent Foramen Ovales.
Authors: Rigatelli G, Zuin M Abstract INTRODUCTION: Nowadays patent foramen ovale (PFO) closure is considered clinically beneficial and even cost-effective over medical therapy in secondary prevention of stroke due to paradoxical embolism. Areas Covered: In this review, the authors discuss both anatomical and technical details and constructive concepts of current devices used for PFO closure. Expert Commentary: Right atrial and interatrial septum anatomy is more complex than usually thought and a unique prosthesis that fits properly to all the possible morphologies is far from being designed. Existing devices can b...
Source: Expert Review of Medical Devices - March 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Data Boosts Support for Abbott, Gore PFO Closure Tech
Devices designed to lower a patient's stroke risk by surgically closing a hole in the heart known as a patent foramen ovale, have historically had a tough time in clinical trials. Data from three separate studies published in the New England Journal of Medicine could go a long way toward boosting support two market-leading PFO closure devices, but figuring out who should have the procedure and who should not continues to be a gray area for clinicians and patients. Long-term results from the RESPECT trial, which evaluated the Amplatzer device that Abbott acquired when it bought St. Jude Medical, along with new data from G...
Source: MDDI - September 15, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Medical Device Business Source Type: news

ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts. The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects. “It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 26, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Ortho Kinematics wins Health Canada nod for VMA system Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system. The VMA system from Austin, Texas-based Ortho Kinema...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Plus 5 Source Type: news

FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote
An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune. The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke. The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper. In a closer vote, the same panel ruled 11-5 that the device’s benefits o...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) St. Jude Medical Source Type: news

FDA Panel Votes 15-1 To Approve St. Jude's Stroke Prevention Device
An FDA panel has issued the green light for St. Jude’s Aplatzer PFO Occluder device, saying studies of the device showed “reasonable assurance” that the device was safe for use. The implant, which is intended to prevent recurrent ischemic strokes in patients with patent foramen ovale (PFO), has been the subject of controversy for decades, and the panel’s decision represents a major milestone for the technology, said St. Jude executives.
Source: Medical Design Online News - May 26, 2016 Category: Medical Equipment Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 13, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Toshiba partners with UCI to study potential brain damage in HS football players Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant
An FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale. The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device,  a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke. Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with dr...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Food & Drug Administration (FDA) St. Jude Medical Source Type: news

HeartStitch touts new PFO closure method
Structural heart focused HeartStitch said today its NobleStitch EL device was used to repair 3 patients with patent forman ovale heart defects in Astana, Kazakhstan. A patent foramen ovale is a congenital heart disease in which hole in the heart that normally seals at birth remains open, and can lead to severe migraines, visual auras and stroke, the company said. The procedures were performed by Dr. Michael Mullen and guided by Anthony Nobles at the National Research Cardiac Surgery Center in Astana, according to the company. “We are gratified that our colleagues from abroad have brought this technology to Kazakhstan...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular HeartStitch Source Type: news