Low-profile balloon catheter for PAD launched

by emma 21. September 2011 13:54

Coyote Balloon Catheter

Boston Scientific has launched its new balloon dilation catheter, Coyote, to treat patients undergoing peripheral angioplasty procedures below the knee.

The Coyote Balloon Catheter is intended to help physicians when treating patients who have challenging obstructive lesions in the lower extremities.

With an ultra-low profile of 0.0174 inches, it promises to be highly deliverable and offer rapid deflation.

Balloon catheters are often used during peripheral angioplasty and stenting procedures to open blocked arteries.

J. A. Mustapha, Director of Endovascular Intervention at Metro Health Hospital in Wyoming, Michigan, said: “Its performance gives me greater confidence in being able to effectively treat patients with difficult anatomy who suffer from peripheral artery disease.”

The device is the latest in a series of balloon catheter products developed by Boston Scientific.  In June, the company launched its Mustang PTA Balloon Catheter, a 0.035 inch percutaneous transluminal angioplasty (PTA) catheter designed to be used in a range of peripheral angioplasty procedures.

Jeff Mirviss, President of Boston Scientific's Peripheral Interventions Division, said the new product launch “builds on Boston Scientific's global leadership in low-profile peripheral balloon angioplasty”.

Up to 9 million US patients suffer from peripheral artery disease, which is associated with high rates of morbidity.

Boston Scientific has begun marketing the product in the US, Europe and other international markets.

Blood clot treatment gets UK launch

by emma 20. September 2011 10:35

Pf product news

A convenient oral treatment patients can take at home to prevent venous thromboembolic events (VTE) following elective total hip or knee replacement surgery is now available in the UK.

Eliquis (apixaban) has been launched through a collaboration between Bristol-Myers Squibb and Pfizer and could help prevent up to 25,000 deaths each year resulting from blood clots.

Dr Ander Cohen, Honorary Consultant Vascular Physician at King's College Hospital, London, says the treatment “represents a new option” for surgeons in the UK.

VTE can lead to two serious conditions: deep vein thrombosis and pulmonary embolism which can lead to death if not treated.

The license of Eliquis is based on the ADVANCE-2 and ADVANCE-3 clinical trials in patients who underwent elective total hip or knee replacements. More than 8,000 patients were assessed during the trials which assessed the efficacy in preventing blood clots and death, and bleeding risk of Eliquis when compared to enoxaparin.

“Clinical data showed that apixaban was more effective than the anticoagulant enoxaparin and importantly, it also showed no increase in bleeding rates compared to enoxaparin,” said Dr Cohen.

Dr Rick Lones, UK Executive Medical Director, BMS, said the two companies “hope to reduce the burden of blood clots” in patients undergoing major surgery after the drug’s release in the UK.

Millions set to benefit from Pradaxa approval

by emma 5. August 2011 14:48

Untitled

Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) has become the first treatment in more than 50 years to be approved in Europe for the prevention of atrial fibrillation-related (AF) strokes.

The breakthrough oral anticoagulant has had its label extended in the EU for the prevention of stroke and systemic embolism (SSE) based on results from the RE-LY study.

Professor Andreas Barner, Chairman of the Board of Managing Directors at Boehringer, says Pradaxa’s approval is an “important milestone” after two decades of R&D.

Pradaxa was initially granted EU approval in 2008 for the prevention of blood clots in adults who have undergone elective total hip or knee replacement surgery.

People with AF are five-times more likely to suffer a stroke, resulting in up to three million individuals suffering strokes each year through the world.

More than 18,000 AF patients conducted in the RE-LY study. The 150mg dose – recommended for the majority of patients – was shown to reduce the risk of SSE by 35%, while also significantly reducing the risk of life-threatening and intracranial bleeding, compared to well-controlled warfarin.

The 110mg – specifically available for elderly patients aged 80 years or above – was shown to be non-inferior to warfarin in reducing the risk of SSE with a significantly lower rate of bleeding.

Professor Gregory Lip, Consultant Cardiologist & Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, says Pradaxa’s approval in Europe is a “major advance” to treat the condition.

“For the past 50 years physicians worldwide have been waiting for an alternative to vitamin K antagonist therapies, such as long time standard of care, warfarin,” he said.

Pradaxa has already been approved for the prevention of stroke in AF in the US, Canada, Japan, Australia and several other countries.

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