A Medical Device Daily

The National Infarct Angioplasty Project (NIAP) final report issued by the UK Department of Health last week says that primary angioplasty is set to become England's first line of treatment for heart attacks, potentially saving hundreds of lives each year.

The NIAP study has concluded that is both feasible and cost-effective to offer angioplasty as an emergency treatment for 97% of the population.

Currently, thrombolysis, the injection of clot-busting drugs, is the most common treatment for heart attack patients in the UK.

The Department of Health said angioplasty is "widely believed to provide superior outcomes, provided that it can be delivered quickly."

According to the NIAP report, clinical evidence shows that using angioplasty as the main treatment for heart attack patients will:

Save around 240 more lives per year.

Reduce complications from treatment of heart attack.

Reduce reoccurrence of heart attack.

Revent around 260 strokes per year.

Decrease the length of stay in hospital for primary angioplasty patients.

The report estimates that 97% of people in England can receive the treatment within acceptable treatment times (120 minutes from call for professional help to delivery of the angioplasty treatment).

Thrombolysis will still be used to treat the 3% or so of patients who would most likely miss the 120-minute window, or who for health reasons couldn't have an angioplasty.

Health Secretary Alan Johnson said, "The national rollout of the primary angioplasty strategy recommended in the NIAP report will save hundreds of lives each year and improve outcomes for many more heart attack patients."

Johnson added that the Department of Health's investment in this study "reinforces its ongoing commitments to tackling cardiovascular heart disease and using clinical evidence to identify the most effective health services. Compared to 1996, nearly 33,000 lives were saved last year in heart disease, stroke and related diseases and inequalities in the death rate from these diseases have been narrowing for the past eight years."

Roger Boyle, national clinical director for heart disease and stroke, said, "As well as providing further evidence of the efficacy of angioplasty, this report shows that a primary angioplasty can be offered to heart attack patients in almost all parts of the country. This is a very positive conclusion in terms of improving outcomes for heart attack patients and ultimately saving lives."

NIAP is an observational study set up by the Department of Health in collaboration with the British Cardiovascular Society and British Cardiovascular Intervention Society.

According to a British Press Association report, the British Heart Foundation welcomed the news, but said the health service must make sure there are sufficient resources to roll out the strategy, which will require extra investment in staff and equipment. "We must not replace a first-class thrombolysis service, which is proven to save lives, with a second-class angioplasty service which might not," the foundation said.

6 hospital teams begin CardioWest training

Heart transplant teams from six new European hospitals began one-week training yesterday on the SynCardia Companion Driver System while completing the first of four phases of certification training to implant the CardioWest temporary Total Artificial Heart manufactured by SynCardia (Tucson, Arizona).

"With the new Companion Driver, stable CardioWest patients will be able to recover at home while they wait for a matching donor heart," said Bansi Koul, MD, surgical director of heart & lung transplantation and artificial heart & aortic surgery programs at University Hospital Lund in Sweden.

SynCardia said that in Europe, where artificial heart patients can wait up to two years for a matching donor heart, discharge drivers allow stable CardioWest artificial heart recipients to shop, travel, visit friends and enjoy a quality of life comparable to people with healthy human hearts.

The Companion Driver system is designed to eventually replace the current hospital driver known as "Big Blue," which weighs 450 pounds. Patients supported by this driver are confined to the hospital while they wait for a donor heart.

The company also has under development the Freedom driver, which is intended to weigh less than 10 pounds and be carried in a backpack or "fanny pack." It is being designed to power the artificial heart through dual interchangeable batteries to allow even better patient mobility.

The six European hospitals in training bring to 41 the number of centers worldwide to start the certification process to implant the CardioWest artificial heart. They include UniversitätsKlinikum Heidelberg (Germany), Ospedale Niguarda Ca'Granda (Milan, Italy), Kerckhoff Klinik (Bad Nauheim, Germany), Centre Hospitalier Universitaire et Régional de Tours (France), Centre Hospitalier Universitaire de Rouen (France) and University Hospital Lund.

SynCardia said it will apply to the FDA during 4Q08 to conduct an IDE clinical study of the Companion Driver in the U.S. and will apply for CE-mark approval in Europe.

Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure.

New patent license for Enigma

Enigma Diagnostics (Porton Down, UK), a company focused on decentralized and point-of-care molecular diagnostics, said it has signed a third license agreement with Applied Biosystems (Foster City, California).

The license provides Enigma with access to claims of U.S. patent No. 5,928,907 that describe methods for monitoring nucleic acid amplification in real time. This is the first such licence Applied Biosystems has granted to the method claims of the '907 patent.

This complements Enigma's existing license under certain patents owned by Applied Biosystems for real-time PCR thermal cyclers.

Financial terms were not disclosed.

Enigma Diagnostics is a private company specializing in developing the next generation of rapid molecular diagnostic instrument platforms for decentralized and point-of-care settings.