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FDA approves NeuroVasx cPAX Aneurysm Treatment System

NeuroVasx announced today that the FDA has approved the cPAX Aneurysm Treatment System as a Humanitarian Use Device for the treatment of large, giant and wide-neck cerebral aneurysms, which are typically the most difficult to treat. The HDE allows for the treatment of up to 4,000 patients per year in the U.S.

6 Apr 2011

RE-LY trial results suggest Pradaxa capsule reduces risk of stroke in AF patients

Two new retrospective subanalyses of the RE-LY trial, involving Pradaxa capsules, suggested that the reduction in stroke risk achieved with PRADAXA 150mg over warfarin occurred irrespective of CHA2DS2-VASc risk score and the type of non-valvular atrial fibrillation.

5 Apr 2011

Less-invasive catheter-based aortic valve replacement as safe and effective as open surgery

Less-invasive catheter-based aortic valve replacement has a similar one-year survival as open valve-replacement surgery for patients at high risk for surgery.

5 Apr 2011

Both radial and femoral approaches are safe and effective for angioplasty

In the future you may hear the doctor say: "Give me your arm and I'll do some heart surgery."

5 Apr 2011

CryoLife files PerClot IDE with FDA to initiate clinical trials in the U.S.

CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, announced today that it has filed an IDE with the United States Food and Drug Administration to begin clinical trials for the purpose of obtaining Pre-Market Approval to distribute PerClot in the U.S. to control bleeding during surgical procedures or following traumatic injuries.

5 Apr 2011

Non-invasive catheterization can lead to positive outcomes in elderly patients with stenosis

A major new study presented today at the yearly scientific meeting of the American College of Cardiology (ACC) in New Orleans shows conclusively that replacing defective aortic valves in elderly patients through non-invasive "catheterization" – rather than through much more invasive open-heart surgery – leads to significantly better outcomes.

4 Apr 2011

Regado's REG1 system Phase 2b trial results presented at i2 Summit

Regado Biosciences, Inc., a privately held company pioneering the development of antithrombotic aptamers with active control agents, announced today the primary results of the RADAR Phase 2b clinical trial of the company's lead product, the anticoagulation system REG1, at the i2 Summit during the American College of Cardiology 2011 60th Annual Scientific Session & Expo in New Orleans, LA.

4 Apr 2011

Omeros announces outcome from OMS103HP Phase 3 study in patients undergoing ACL surgery

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today reported the outcome from its Phase 3 program evaluating OMS103HP in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.

1 Apr 2011

Routine sonograms after IUD insertion can reduce pregnancy complications

A retrospective study of women who became pregnant while using intrauterine devices shows that more than half of the IUDs were malpositioned.

30 Mar 2011

Pelvic arterial embolization therapy effective treatment for postpartum hemorrhage

Pelvic arterial embolization or PAE, a minimally invasive, life-saving therapy, is a safe and effective treatment for postpartum hemorrhage, say researchers at the Society of Interventional Radiology's 36th Annual Scientific Meeting in Chicago, Ill.

30 Mar 2011

Navy sonar experts develop new medical device for stroke detection

A medical device developed by retired U.S. Navy sonar experts, using submarine technology, is a new paradigm for the detection, diagnosis and monitoring of stroke, says a team of interventional radiologists at the Society of Interventional Radiology's 36th Annual Scientific Meeting in Chicago, Ill.

30 Mar 2011

ACCF, AHA guidelines recognize Effient as Class I treatment option for patients with ACS-PCI

Oral antiplatelet therapy Effient has been added to the updated clinical practice guidelines as a Class I recommended treatment option for patients undergoing percutaneous coronary intervention fter experiencing heart-related chest pain at rest or non-ST segment elevation myocardial infarction.

30 Mar 2011

Uterine fibroid embolization reduces fibroid-related urinary symptoms

Uterine fibroid embolization—an interventional radiology treatment for the noncancerous yet very common growths that develop in the muscular wall of the uterus—improves a number of women's lower urinary tract problems that are specifically caused by those fibroids, confirm researchers at the Society of Interventional Radiology's 36th Annual Scientific Meeting in Chicago, Ill.

30 Mar 2011

Natural disasters can produce major lung problems

A comprehensive new review published in the journal Respirology indicates that lung problems are major causes of morbidity and mortality following natural disasters.

29 Mar 2011

UC San Diego student to make medical imaging available in low-income countries

Benjamin Johnson, a fourth-year student at the University of California, San Diego School of Medicine is determined to make medical imaging technology widely available in low-income countries. His journey started in Uganda, where currently just 35 local radiologists serve the needs of 30 million people.

29 Mar 2011

Inflammatory bowel disease in children - Delays in diagnosis common

Once a medical rarity in children, inflammatory bowel disease today is increasingly common in kids, but many of them may not be diagnosed in a timely manner, according to experts from the Pediatric Inflammatory Bowel Disease Center at Johns Hopkins Children’s Center.

28 Mar 2011

Swallowed button battery can generate electrical current and cause serious tissue damage

To mark National Poison Prevention week, Trauma specialists at The Montreal Children's Hospital (MCH) of the McGill University Health Centre are urging parents to seek immediate medical attention if their child has swallowed a button battery. Parents should not assume the tiny battery will harmlessly pass through their child's system.

25 Mar 2011

Merck to return rights for betrixaban to Portola

Portola Pharmaceuticals and Merck, known as MSD outside the United States and Canada, today announced that Merck plans to return to Portola all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF). This decision was made following a review of Merck's investigational portfolio.

25 Mar 2011

'Consent rituals' cause life-threatening delays

Current rules requiring researchers to obtain consent for patients to take part in clinical trials in emergency situations are causing life-threatening delays to treatment, experts have argued.

25 Mar 2011

Dabigatran etexilate is less costly, more effective for stroke treatment in patients with AF

A new economic analysis, published online in Thrombosis and Haemostasis, suggested that Boehringer Ingelheim's novel oral direct thrombin inhibitor dabigatran etexilate is cost-effective compared to current treatment options, particularly in real-world clinical practice.

25 Mar 2011

Bleeding News and Research

FDA approves NeuroVasx cPAX Aneurysm Treatment System

RE-LY trial results suggest Pradaxa capsule reduces risk of stroke in AF patients

Less-invasive catheter-based aortic valve replacement as safe and effective as open surgery

Both radial and femoral approaches are safe and effective for angioplasty

CryoLife files PerClot IDE with FDA to initiate clinical trials in the U.S.

Non-invasive catheterization can lead to positive outcomes in elderly patients with stenosis

Regado's REG1 system Phase 2b trial results presented at i2 Summit

Omeros announces outcome from OMS103HP Phase 3 study in patients undergoing ACL surgery

Routine sonograms after IUD insertion can reduce pregnancy complications

Pelvic arterial embolization therapy effective treatment for postpartum hemorrhage

Navy sonar experts develop new medical device for stroke detection

ACCF, AHA guidelines recognize Effient as Class I treatment option for patients with ACS-PCI

Uterine fibroid embolization reduces fibroid-related urinary symptoms

Natural disasters can produce major lung problems

UC San Diego student to make medical imaging available in low-income countries

Inflammatory bowel disease in children - Delays in diagnosis common

Swallowed button battery can generate electrical current and cause serious tissue damage

Merck to return rights for betrixaban to Portola

'Consent rituals' cause life-threatening delays

Dabigatran etexilate is less costly, more effective for stroke treatment in patients with AF

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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