A Medical Device Daily

Sweden's first implant of the CardioWest temporary total artificial heart made by SynCardia (Tucson, Arizona) was performed earlier this month at Sahlgrenska University Hospital in Gothenburg.

Ulf Kjellman, MD, head of the ventricular assist device program at Sahlgrenska, implanted the device into a 31-year-old male patient on Oct. 15.

"If it weren't for the CardioWest artificial heart, this patient would have died," said Kjellman. "Both sides of his heart were failing. He needed a heart transplant to survive, but no donor heart was available. His only option was for us to implant the CardioWest artificial heart as a bridge to transplant."

The surgeon added, "The artificial heart will make him a stronger and healthier transplant candidate while he waits for a matching donor heart."

SynCardia noted that in some countries in Europe, artificial heart patients can wait up to two years for a matching donor heart, adding that since mid-July 2006, stable CardioWest patients in Europe have been able to recover at home thanks to the company's Companion Driver System, which is designed for use in both the hospital and at home.

"Discharge drivers substantially reduce the costs associated with in-hospital care, while allowing stable CardioWest patients to shop, travel, visit friends and enjoy a quality of life comparable to people with human hearts," said Kjellman.

SynCardia has said that it will apply to the FDA during the current quarter to conduct an IDE clinical study of the Companion Driver System in the U.S., and also will apply for CE-mark approval in Europe.

The company said it projects a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the 24 months following regulatory approvals.

Sahlgrenska University Hospital is the largest hospital in northern Europe, with more than 2,700 beds and 140 departments. The implant marked Sahlgrenska University Hospital's completion of the CardioWest certification training program, which staff directed by Lars Wiklund, MD, chief of cardiothoracic surgery, started in August 2007.

The hospital is the 26th in the world and the 13th in Europe to become a CardioWest certified center. Sweden joins Germany, France, Austria and Italy as European countries with a hospital certified to implant the CardioWest artificial heart.

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.

The CardioWest is the only temporary total artificial heart with FDA, Health Canada and CE-mark approval. To date, there have been more than 750 implants of the CardioWest artificial heart, accounting for in excess of 140 patient years of life on the device.

Agreement links Sectra Imtec, DIPS

Sectra Imtec (Linköping, Sweden), the market leader for digital radiology systems in Scandinavia, and DIPS (Bodø, Norway), the largest supplier of electronic patient record (EPR) systems in Norway, have signed a cooperation agreement.

The intent of the accord is to offer what the companies said would be the Norwegian market's "most efficient healthcare IT solutions through tight integration of the companies' systems for EPR, radiology information (RIS) and radiology images (PACS)."

Both companies' systems are currently installed in a large number of hospitals throughout Norway. Through the agreement, Sectra and DIPS said they will offer these hospitals more efficient handling of patient information and radiology images.

In unveiling the agreement, the companies said there is an increasing need to achieve increased efficiency in the healthcare sector. More patients, more information and a growing number of radiology images must be processed more rapidly at a lower cost – without the hospital compromising on the quality of care.

The long-term goal is fully integrated EPR and image functionality based on the customers' user needs and integration and efficiency-enhancement potential.

"Increased coordination of healthcare IT systems is paramount in meeting tomorrow's demands for increased productivity," said Sectra Imtec President Torbjörn Kronander. "Initially, this cooperation will strengthen the offering to our joint customers in Norway, but it may also be expanded to other markets in which both companies are active."

DIPS President Tor-Arne Viksjø, said, "This cooperation means that we will be able to better utilize the systems' integration possibilities. As a result, we can further enhance the efficiency of the management of information and images at the hospitals. The cooperation supports our strategy of delivering user-friendly solutions that improve the efficiency of our customers' operations."

Self-referrals okayed in the UK

UK Health Secretary Alan Johnson has unveiled a program under which more people should have the freedom to self-refer for services such as physiotherapy and podiatry, which he said will further empower patients and could help cut waiting times.

While some allied health professionals (AHPs) already take on self-referrals, many do not, and Johnson's announcement will give the go-ahead across the profession.

As part of a package of improvements to AHP services, he also noted the intention to collect new data on these areas to support the improvement of services. "We will also introduce quality measures, which will lead to improvements in the overall standard of these services for patients and the public."

Research carried out by the Department of Health in partnership with the Chartered Society of Physiotherapy showed that self-referral to musculoskeletal physiotherapy resulted in patients accessing services more quickly, as well as being more likely to complete their course of treatment and turn up for follow-up appointments.

The research also showed that self-referral resulted in a lower level of work absence for patients and a high level of satisfaction from patients, general practitioners and physiotherapists.

"I am giving the green light to physiotherapists, podiatrists and all AHPs that they can accept patients who self-refer," Johnson said. "Self-referral will help both vulnerable members of society and those with busy lives by providing quicker access without the unnecessary hoop jumping of going to see a doctor first."

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