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)
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
Structural heart: Nobles Medical, HeartStitch tout cardiac suture procedures
Structural heart focused HeartStitch and Nobles Medical today touted separate procedures utilizing cardiac sutures with the company’s Hearstitch ST and Noblestitch EL devices. Nobles Medical Tech said that the NobleStitch EL device was used in the 1st percutaneous ASD closure and ASA repair and remodeling without the use of an implantable device. The NobleStitch EL device closes the hole through a minimally invasive cardiovascular suturing procedure, the company said, with a routine cardiac catheterization procedure to secure the closure. “This was the 1st time we used the NobleStitch cardiovascular suturing d...
Source: Mass Device - March 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials HeartStitch Nobles Medical Technology Source Type: news
ISC: Closure May Prevent Further Patent Foramen Ovale-Related Strokes (CME/CE)
(MedPage Today) -- Analysis of RESPECT trial suggests fewer PFO-related second strokes with device closure (Source: MedPage Today Meeting Coverage)
Source: MedPage Today Meeting Coverage - February 18, 2016 Category: Journals (General) Source Type: news
Closure May Prevent Further Patent Foramen Ovale-Related Strokes (CME/CE)
(MedPage Today) -- Analysis of RESPECT trial suggests fewer PFO-related second strokes with device closure (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 18, 2016 Category: Cardiology Source Type: news
This month’s most missed USMLE question--and the right answer
As you prepare for the United States Medical Licensing Exam® (USMLE®), do you know which questions to look out for? We’re giving you an exclusive scoop on the most challenging USMLE test prep questions and expert strategies to help you beat them. Find out what this month’s toughest question is and receive an expert video explanation of the answer from Kaplan Medical. Welcome to the third post in AMA Wire’s® series, “Tutor talk: Tips from Kaplan Medical on the most missed USMLE test prep questions.” Each month, we’re revealing one of the top questions students miss, a helpful analysis of answers and a v...
Source: AMA Wire - November 25, 2015 Category: Journals (General) Authors: Troy Parks 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
"I Had A Stroke at 38 Years Old"
How one woman turned a life-changing event into an opportunity to thrive. As told to Kristin Canning By Kristin Canning, SELF (Photo: Courtesy of Merideth Gilmor) I wasn't supposed to have a stroke. I was 38 years old, a mom in "perfect" health. I run my own pro-athlete public relations firm, so I have to stay on pace with the likes of Maria Sharapova, Cam Newton and Colin Kaepernick. I was under stress, sure, but I was happy, enjoying my crazy, packed days. It happened about a year ago. One of my best friends was getting married in the Berkshire Mountains, so I flew from Charlotte, North Carolina, where I'd been on b...
Source: Healthy Living - The Huffington Post - August 26, 2015 Category: Consumer Health News Source Type: news
Minor heart feature may mean trouble at high altitude
A common heart feature long thought to have negligible effects on human health and performance may be problematic at high altitude. That's a key finding from a study that looked at the effects of a condition known as patent foramen ovale in a high-altitude Bolivian setting. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - June 30, 2015 Category: Science Source Type: news
Oregon study: Minor heart feature may mean trouble at high altitude
(University of Oregon) A common heart feature long thought to have negligible effects on human health and performance may be problematic at high altitude. That's a key finding from a University of Oregon study that looked at the effects of a condition known as patent foramen ovale in a high-altitude Bolivian setting. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 30, 2015 Category: Global & Universal Source Type: news
Another PFO Closure Study Yields Mixed Migraine Results Another PFO Closure Study Yields Mixed Migraine Results
The latest trial to investigate patent foramen ovale closure as potential treatment for refractory migraine has again yielded overall negative results but suggests possible benefit for those with aura. Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - June 26, 2015 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news
“I’m Just In the Band”
Discussion Instrumental music, either as an avocation or profession, provides great pleasure for those performing and listening. Unfortunately it can also cause health problems. Many of the problems are musculoskeletal or neurological in etiology due to overuse and the musician may experience pain. Prelude to pain can include stiffness or tingling or other skin sensations. Musicians may experience weakness, loss of function, control (accuracy) and ability (speed) as well as problems with tone. “The most prevent problems involve overuse of muscles resulting from repetitive movements of playing, often in combination ...
Source: PediatricEducation.org - November 17, 2014 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
Closure of Patent Foramen Ovale Cuts Recurrent Stroke/TIA Risk
Reviews demonstrate reduction in recurrent stroke risk after percutaneous transcatheter PFO closure (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - November 11, 2014 Category: Respiratory Medicine Tags: Cardiology, Internal Medicine, Critical Care, Neurology, Pulmonology, Surgery, Journal, Source Type: news
Key Blood Chemistry Changes Seen After PFO Closure Key Blood Chemistry Changes Seen After PFO Closure
The findings suggest there's more to the risk for stroke associated with patent foramen ovale than simply allowing clots to pass to the brain. Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - October 29, 2014 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news