A Medical Device Daily

As part of its continued efforts to focus on its core cardiovascular businesses in order to transform into a faster-growing, more profitable company, Edwards Lifesciences (Irvine, California) reported that it is realigning its business in Japan.

The realignment includes selling the company's cardio-pulmonary products business in Japan to Terumo (Tokyo), that country's leading cardiovascular company, for total consideration of between $10 million and $20 million, based upon Edwards achieving certain milestones.

Edwards also is exiting its pacemaker distribution business in Japan and restructuring its operations in that country. The transactions will result in the transfer or elimination of about 60 full-time positions. Further details were not disclosed.

“By focusing on Edwards' core cardiovascular businesses and divesting some of our less-strategic, distributed products, we expect to increase our growth rate in Japan and best position the organization for long-term success,“ said Huimin Wang, MD, Edwards' corporate vice president and president, Japan and Intercontinental. “Decreasing reimbursement, combined with shifts in market trends for these distributed products, provided us with the impetus to enact this plan and align our Japan operations with [our] global strategy of increasing growth and profitability.“

The company said the realignment would result in a special charge of between $6 million and $9 million in 1Q05.

Edwards said these businesses being sold operated below its average sales growth and gross margin rates. It said their divestiture “will improve these measures going forward.“

The net result of the realignment will reduce the company's annual earnings by about $3 million, Edwards said. Although the realignment is “slightly dilutive“ to 2005 earnings, it said it remains comfortable with the current Thomson First Call full-year earnings per share estimate of $1.90, excluding the special charge.

Edwards refers to itself as the No. 1 heart valve company in the world, as well as the global leader in acute hemodynamic monitoring. Its focus on heart valve disease, peripheral vascular disease and critical care technologies is reflected in its brands, which include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, Perimount and Swan-Ganz.

It sells in about 100 countries.

Pilot implementation in Tunisia

VisualMED Clinical Solutions (Montreal) said its European distribution partners are moving ahead with a planned pilot implementation in one of Tunisia's most modern hospitals, in partnership with Sonotec, a leading medical equipment company in that country.

Sonotec's products are found in every major Tunisian hospital, and the company has represented major North American, European and Japanese interests in the region for more than 20 years.

The VisualMED Clinical Information System (CIS) is a software application built to conform to the way doctors and nurses provide and document patient care. The company said VisualMED CIS is the only solution of its kind to have been wholly designed by practicing medical staff in terms of both workflow and user interface.

The partnership in Tunisia is sponsored by the Canadian International Development Agency (CIDA).

“We're very happy with this latest breakthrough in a promising market,“ said Gerard Dab, VisualMED Chairman and CEO. “Tunisia and some of the other regions of North Africa have quite a modern healthcare system and represent a significant opportunity for our multi-language platform that currently supports applications in English, French, Spanish, Italian, German and Dutch.“

There are more than 15 mid-sized hospitals in Tunisia, both private and public, that VisualMED said can profit from the “cost reduction and life-saving benefits“ provided by its system. Many Tunisian hospitals offer full-service medical care to European patients looking for timely treatment.

The main site under consideration for the pilot project is the 400-bed Habib Thameur Hospital (Tunis, Tunisia), third-largest hospital in that city. According to Denis Paradis, of Ecole des Hautes Etudes Commerciales (Montreal), chief consultant on the project, said, “Our studies of the North African healthcare industry clearly indicate an open and willing market for advanced technologies like VisualMED.“

VisualMED Clinical Solutions creates clinical management solutions that help hospitals and healthcare authorities reduce medication errors, increase personnel efficiency and bring down operating costs. One of its key components, Computerized Physician Order Entry, is a core solution in the new agenda to promote greater patient safety and reduce the morbidity and mortality associated with medication error.

Liver iron test gets okay in U.S.

Resonance Health Ltd. (Perth, Australia) said its subsidiary, Inner Vision Biometrics Pty Ltd. (IVB; Perth, Australia), has achieved FDA marketing approval for FerriScan, its non-invasive diagnostic test for liver iron concentration.

The company said an estimated 4 million people in the U.S. are afflicted with an iron overload disease such as hemochromotosis and thalassemia.

U.S. approval for FerriScan follows the listing of FerriScan by the Australian Therapeutic Goods Administration and European CE mark approval achieved at the end of last year.

Existing partnerships with diagnostic imaging companies will be used to offer the test in Australia and Europe, while partnerships with such companies are also being developed for the U.S.

Tony Fitzgerald, executive director of Resonance Health, said, “We will be meeting with major U.S.-based diagnostic imaging groups over the next several weeks to accelerate arrangements for the U.S. commercial launch of the FerriScan test. The U.S. has a well-developed MRI infrastructure and attractive pricing to underpin commercial success for FerriScan.“