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 outweigh its risks and 9-7 that it is effective for its intended use. “We’ve searched long and hard for new ways to prevent the risk of recurrent strokes in patients with a PFO, as these strokes can often be debilitating. For these patients, closure with the Amplatzer PFO Occluder is an important treatment option, and today is an important step toward approval of this technology in the United States,” chief medical officer Dr. Mark Carlson said, according to the Star Tribune. Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with drug therapy in patients with recurrent cryptogenic stroke and PFO. The Respect study showed that 9 patients in the Amplatzer arm suffered non-fatal strokes, compared with 16 in the drug treatment cohor...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) St. Jude Medical Source Type: news

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Abstract Paradoxical embolism should be suspected in front of a clinical phenomenon of thromboembolism associated with an anatomical right-to-left shunt. Others potential cardiac sources of thromboembolism must be ruled out. Strokes constitute the most frequent clinical manifestations of paradoxical embolism. Right-to-left left shunts are in connection with intracardiac defects (atrial septal defect and patent foramen ovale) or pulmonary arteriovenous malformations. The probability that a discovered PFO is stroke-related can be evaluated by a score. Therapeutic approaches for secondary prevention of recurrent stro...
Source: Annales de Cardiologie et d'Angeiologie - Category: Cardiology Authors: Tags: Ann Cardiol Angeiol (Paris) Source Type: research
(This post introduces my latest column on TheHeart.org | Medscape Cardiology. It’s about stroke in young people.)  *** We define stroke as the death of brain cells. The typical cause is a blocked blood vessel in the brain. Stroke usually occurs in older people who have established blood vessel disease. Stroke is bad; it may be the worst outcome in all of medicine. That’s because stroke can permanently remove basic functions of being human, things such as speech, thought, personality, movement, swallowing, and many others. Stroke is not supposed to happen in young people. But sometimes it does. And in some ...
Source: Dr John M - Category: Cardiology Authors: Source Type: blogs
A device used to close a small hole in the heart may benefit certain stroke patients by providing an extra layer of protection for those facing years of ongoing stroke risk, according to the results of a large clinical trial led by UCLA researchers.“It is a major new treatment option for some people,” said Dr. Jeffrey Saver, director of theUCLA Comprehensive Stroke Center and lead author of the study. However, he added, “Using the device is going to have to be a considered clinical decision between the doctor and the patient about who’s the right person to get it.”Thefindings appear in the Sep...
Source: UCLA Newsroom: Health Sciences - Category: Universities & Medical Training Source Type: news
By ANISH KOKA, MD Strokes are the third leading cause of death in the United States. 800,000 people suffer a stroke every year, and the consequences are frequently devastating. Lives are not just lost, but changed forever – speech permanently silenced, arms and legs turned into useless appendages. The brain is very expensive real estate and it is little surprise that a clot the size of a pinhead lodged in a blood vessel feeding the brain is all that is needed to wreak a devastation most fear worse than death. Most of the time the source of the debris that results in a stroke can be readily identified, but at least on...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: blogs
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 - Category: Medical Equipment Authors: Tags: Blog Plus 5 Source Type: news
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 - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news
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 c...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Clinical Trials Food & Drug Administration (FDA) St. Jude Medical Source Type: news
Please wait while the activity loads. If this activity does not load, try refreshing your browser. Also, this page requires javascript. Please visit using a browser with javascript enabled. If loading fails, click here to try again Click on the 'Start' button to begin the mock test. After answering all questions, click on the 'Get Results' button to display your score and the explanations. There is no time limit for this mock test. Start Congratulations - you have completed DM / DNB Cardiology Entrance Mock Test 11.You scored %%SCORE%% out of %%TOTAL%%.Your performance has been rated as %%...
Source: Cardiophile MD - Category: Cardiology Authors: Tags: Cardiology MCQ DM / DNB Cardiology Entrance Featured Source Type: blogs
Please wait while the activity loads. If this activity does not load, try refreshing your browser. Also, this page requires javascript. Please visit using a browser with javascript enabled. If loading fails, click here to try again Click on the 'Start' button to begin the mock test. After answering all questions, click on the 'Get Results' button to display your score and the explanations. There is no time limit for this mock test. Start Congratulations - you have completed DM / DNB Cardiology Entrance Mock Test 7. You scored %%SCORE%% out of %%TOTAL%%. Your performance has been rate...
Source: Cardiophile MD - Category: Cardiology Authors: Tags: Cardiology MCQ DM / DNB Cardiology Entrance Featured Source Type: blogs
Illustrated Review with ECG, CXR, Echo Video, Cath Images X-ray chest in atrial septal defect X-ray chest PA view in atrial septal defect with pulmonary hypertension (Click on the image for an enlarged view) The main pulmonary artery (MPA) is grossly dilated. The right pulmonary artery (RPA) is also quite enlarged. Right atrial enlargement is seen as a shift of the cardiac contour to the right of the spine. Pulmonary vascularity is increased and prominent end on vessels (End on) are also seen. Apex is upwards, suggesting a right ventricular configuration. All features suggest a large secundum atrial septal defect with a l...
Source: Cardiophile MD - Category: Cardiology Authors: Tags: Angiography and Interventions Cardiology X-ray ECG / Electrophysiology Echocardiography Structural Heart Disease Interventions ASD Crochetage Sign ASD ECG ASD echo ASD Echo Video ASD X-Ray Chest PA Colour Doppler Echo in ASD ECG in A Source Type: blogs
More News: Cardiology | Cardiovascular | Heart | Hole in the Heart | Medical Devices | Patent Foramen Ovale | Statistics | Stroke | Study | Thrombosis