A Medical Device Daily

Medtronic Europe (Tolochenaz, Switzerland) said it supports the new guidelines for the treatment of heart failure (HF) issued by the European Society of Cardiology (ESC; Sophia Antipolis, France).

The company said that under the new ESC heart failure guidelines, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) have been designated Class I for indicated heart failure (HF) patients, which means they are recognized as standard-of-care treat- ments for many heart failure patients already on optimal medical therapy.

The guidelines stipulate that:

• ICDs are recommended for indicated HF patients with reduced ejection fraction to decrease sudden cardiac arrest (SCA).
• CRT is recommended in HF patients with reduced ejection fraction and cardiac dyssynchrony to improve symptoms and reduce mortality and hospitalizations.

“We are very pleased that the European Society of Cardiology is recommending routine use of defibrillators and CRT for heart failure patients with systolic dysfunction,” said Peter Steinmann, vice president of Medtronic Cardiac Rhythm Management in Western Europe. “ICDs can correct deadly fast heart rhythms, the leading cause of mortality in heart failure patients. These implantable devices will protect thousands of patients from sudden cardiac death.”

Defibrillation therapy is the only treatment option with the potential to reverse sudden cardiac arrest and thereby reduce mortality in HF patients who suffer a lethal heart rhythm.

“Based on several clinical trials, ICDs are now proven to effectively reduce sudden death among patients with heart failure and reduced systolic dysfunction,” said Karl Swedberg, MD, of Sahlgrenska University Hospital at Ostra (Gotenborg, Sweden). “It is now up to the medical community to define which patients should be treated in clinical practice.”

Medtronic noted that extensive recent scientific evidence “demonstrates that ICDs prolong lives when used in conjunction with optimal drug therapy in indicated heart failure patients,” including the Medtronic-supported Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which was published in the Jan. 20 issue of The New England Journal of Medicine, showing that ICDs increased survival by 23%.

It also said that results from the recent Medtronic-sponsored CARE-HF (Cardiac Resynchronization in Heart Failure) study, published in the April 14 issue of The New England Journal of Medicine, contributed to the ESC decision to designate CRT as Class I therapy for heart failure patients.

New European facility for Sterigenics

Sterigenics International (Oak Brook, Illinois), which describes itself as “the global leader in contract sterilization services for the medical device industry,” said it would “add significantly” to its European capacity with the opening of a new facility in Germany.

The company will commence operations at its ethylene oxide (EO) processing facility in Wiesbaden, Germany, this month. “Sterigenics will use the new Wiesbaden facility to introduce its breakthrough CyclEOne technology to the European market,” said Marc Markey, deputy CEO. “We are experiencing significant market growth and are pleased to add the extra capacity.”

CyclEOne, which the company said is designed to help provide rapid turnaround of materials needing sterilization, combines pre-conditions, processes and aerates in a single chamber in a single day, trimming nine to 13 days from the conventional EO processing cycle. It said that by including Parametric Release, which removes the need for biological indicators, “customers will be able to achieve even greater speed to market.”

Sterigenics also will open a new electron-beam (E-beam) facility in Shanghai, China, in September. The company said the new facility “will answer the increasing needs of manufacturers of surgical dressings, non-woven surgical drapes and gowns and simple plastic devices.”

Markey said Sterigenics sees “excellent opportunities” in China for “quality processing for companies manufacturing for export markets.”

The company said it would offer “the most advanced processing equipment, as well as leading-edge environmental management technology” in both of the new facilities.

CEO David Meyer said, “It is exciting to grow the business with our customers in markets where we are able to add significant value.” He added: “We are . . . truly a technology-neutral provider that uses gamma, E-beam, EO and, eventually, X-ray, to best meet the needs of our customers.”

Meyer said the company’s owners, PPM Capital Ltd. and PPM America Capital Partners, who acquired Sterigenics in June 2004, “continue to support our strategic direction. Under their ownership, we have made, and continue to make, significant investments in our business on a worldwide basis.”

Sterigenics has more than 1,000 employees and operates 38 service centers in North America, Europe and Asia.

Jeavons named to IT implementation role

Richard Jeavons has been named director of IT service implementation in the UK Department of Health, replacing Alan Burns, who is resigning from his IT role after becoming chief executive of the Norfolk, Suffok and Cam- bridgeshire Strategic Health Authority. Burns also will continue as chief executive of Trent SHA.

Former Norfolk, Suffok and Cambridgeshire SHA chief executive Peter Houghton left to take up the position of director of the National Leadership Network for the National Health Service (NHS).

Jeavons has been serving as senior responsible owner for the North East Cluster of NHS Connecting for Health and chief executive of West Yorkshire SHA. He is stepping down from both of those posts in order to concentrate on his role in leading clinical and management engagement in the NHS’s IT modernization program.

Mike Farrar, chief executive of South Yorkshire SHA, will become chief executive of West Yorkshire SHA. His deputy and South Yorkshire SHA director of finance, Alan Wittrick, will move up to chief executive of that SHA.

Burns will be replaced in his role as senior responsible owner for the East Midlands and Eastern Cluster of the National Program for IT by John de Braux, chief executive of Bedfordshire and Hertfordshire SHA.