A Medical Device Daily

Sorin Group (Milan, Italy) reported that it has closed the divestiture of its Vascular Therapy business unit to CID Investimenti, an investment consortium led by the independent private equity firm IP Investimenti e Partecipazioni.

The deal includes provisions for sharing of future proceeds from certain transactions regarding the intellectual property portfolio.

CID Investimenti becomes the new owner of the entire Sorin coronary vascular therapy business worldwide, including its intellectual property portfolio.

"The closing of this transaction is a key milestone for Sorin Group," said CEO Andr -Michel Ballester. "It confirms our commitment to concentrate our resources on our three cardiovascular businesses: Heart Valves, Cardiopulmonary and Cardiac Rhythm Management."

The latest transaction follows the sale of Sorin's endovascular business to Datascope (Montvale, New Jersey) in June.

With the divestiture, Sorin Group will deconsolidate, the results of the coronary Vascular Therapy business activities retroactively as of Jan. 1, 2008, with those results being recognized as earnings from discontinued operations.

The company said the estimated impact on a full-year basis will include a decline in net revenues of €17 million and an increase of €3 million in EBITDA. Net debt also will be positively impacted by about 13 million in 2008 as a result of the net proceeds of the disposal, and by an additional 18 million in 2009 as a result of the settlement of the receivables and payables associated with the Vascular Therapy Business Unit.

The consolidated estimated loss on disposal of assets associated with the divestiture will be roughly €7 million, including a €1 million restructuring charge for realignment expenses associated with the divestiture.

Sorin raised its full-year guidance, calling for 1% growth in revenues without the VT business vs. flat under the previous structure and 12% growth in EBITDA margin vs. 11.5% growth previously.

Sorin Group is a global developer of technologies for cardiac surgery, as well as therapies for cardiac rhythm dysfunctions and for the treatment of chronic kidney diseases.

It has more than 3,500 employees worldwide, serving in excess of 5,000 public and private treatment centers. Sorin said that each year, some 1 million patients are treated with its devices in more than 80 countries.

Label expansion for Intercept treatment

Cerus (Concord, California) said it has obtained approval for a CE mark label expansion extending the time within which plasma can be treated with the Intercept Blood System to 20 hours after collection.

The prior approved label claim allowed Intercept treatment only within eight hours of blood collection. This new extended treatment window applies to plasma from single-donor apheresis and pooled whole blood collections.

The company said that with this label expansion, "Blood centers using the Intercept Blood System will be able to simplify their processing logistics. Whole blood from mobile donor drives, the source of most donated blood, can be collected in the afternoon, held overnight, and then processed into platelet, plasma and red blood cell components the following day."

Cerus said the expanded time for treatment allows processing of more plasma with Intercept at lower costs due to improved collection, transportation, and storage logistics.

"This label change is especially important to blood centers that depend on mobile blood drives and then have to transport the blood back to centralized processing facilities," said Laurence Corash, senior VP/chief medical officer of Cerus.

1st patient treated using planning system

RaySearch Laboratories (Stockholm, Sweden) reported that the first patient has been treated at Uppsala University Hospital (Uppsala, Sweden) with a treatment plan prepared using a new treatment planning system supplied by the company.

An agreement was signed with the hospital in August for installation of the new system at the Svedberg Laboratory, which is integrated in the Oncentra MasterPlan treatment planning system from RaySearch's partner, Nucletron (Veenendaal, the Netherlands).

"The new treatment planning system saves substantial time with its user-friendly tools providing us with various optimization alternatives and the possibilities of making fine adjustments," said Christina Vallhagen Dahlgren, senior hospital physicist for proton therapy at University Hospital. "The dose calculations are exact and optimized to the clinical reality."

RaySearch President Johan L f said, "Radiation therapy with protons is a strategically important area for RaySearch and we are working intensively to realize a competitive system for treatment planning of proton therapy. The first patient treated with the use of our system is a key milestone in our efforts to deliver solutions to existing and new proton centers worldwide."

The company's products are sold through license agreements with partners such as IBA Dosimetry, Nucletron, Philips, TomoTherapy and Varian. Eight products have been released to date, and license agreements cover more than 15 other products that are scheduled to be launched in the coming years.

RaySearch was founded in 2000 as a spin-off from Karolinska Institute in Stockholm.

CE mark given Cobas hepatitis test

Roche Molecular Diagnostics (Pleasanton, California) reported receiving the CE mark for its Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0. The test offers the company's fully automated real-time polymerase chain reaction technology to achieve a broad dynamic range for the quantitative detection of hepatitis B virus (HBV) DNA in patient plasma and serum.

According to the World Health Organization (Geneva, Switzerland), some 2 billion people worldwide and about 350 million in Europe live with chronic HBV infection and are at risk of developing end stage liver disease and liver cancer.

"It is critical to monitor the levels of circulating hepatitis B virus as an indicator as to when hepatitis B therapies should be started, and to determine response to treatment," said Teresa Wright, MD, chief medical officer at Roche Molecular Diagnostics. "This test enables doctors to optimize patient treatment with standardized viral load measurements and enables laboratories to test efficiently with improved automation."