Medical Device Daily
and MDD

Fresenius Medical Care (Bad Homburg, Germany), the largest global provider of dialysis products and services, reported sales for full-year 2007 up 12% in constant currency at €7 billion ($10.6 billion).

The company said it is targeting $10.6 billion for 2008 and expects to grow to $11.5 billion by 2011.

In 2007 Fresenius treated 173,863 patients worldwide, a 6% increase, delivering about 26.4 million dialysis treatments in the 2,238 clinics it operates, of which 1,602 are located in North America.

Fresenius Medical accounts for 60% of the sales for the parent Fresenius Group, also based in Bad Homburg, which reported sales of €11.4 billion ($17.3 billion) in 2007, up 10% in constant currency. The group reported €410 million ($623 million) in net income.

Fresenius Group, which trades on the Frankfurt exchange, said it clearly exceeded financial targets and posted an increase in dividend for the 11th consecutive year. EPS rose by 33% to $2.43.

Fresenius Kabi, specializing in infusion therapy and clinical nutrition for critically ill patients in Europe, Asia-Pacific and Latin America, generated €2 billion ($3.1 billion)

Helios Kliniken Group (Berlin), a private hospital group of 60 clinics and hospitals, generated €1.8 billion ($2.7 billion) for the Fresenius Group. Helios Kliniken focuses on acute treatment and rehabilitation and employs 30,000 people, primarily in Germany.

A healthcare project manager, Fresenius VAMED (Vienna, Austria), reported €408 million ($620 million) through 450 service, maintenance and turnkey hospital projects in 47 countries.

VAMED operates in the project and management business of healthcare facilities worldwide. These include hospitals and healthcare centers as well as spas and wellness centers. The company has 1,800 of its own employees and is responsible for more than 6,000 employees including all projects worldwide. VAMED has completed about 450 projects in 47 countries since its foundation in 1982.

1st implants for Cognis, Teligen

Boston Scientific (Natick, Massachusetts) reported the first European implants of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (ICD).

Physicians began performing implants last week, with 40 implants having been performed in 14 hospitals in six countries as of the issuance of the company’s statement on Thursday.

The company said the Cognis and Teligen devices are designed to eliminate the compromises physicians often must make among device size, battery longevity and features. They are among the world’s smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick.

Boston Sci said the new CRT-D and ICD “offer features based on significant engineering advances, including extended battery longevity, self- correcting software and improved programming technology.”

The Cognis CRT-D and Teligen ICD received CE-mark approval last month (Medical Device Daily, Jan.25, 2008). The company said it plans to build to a full launch in Europe and other international markets in the second quarter.

“The Cognis CRT-D offers ... several new features that will help me better manage my heart failure patients,” said Poul-Erik Bloch-Thomsen, MD, of Gentofte Hospital (Hellerup, Denmark).

Lieselotte van Erven, MD, of Leiden University Medical Center (Leiden, the Netherlands), said, “The Teligen ... offers me flexibility for delivering defibrillation to my patients and helps ensure that the right therapy is delivered at the appropriate time.”

Boston Scientific also reported CE-mark approval of its Acuity Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.

The company said the product features a spiral design and small lead tip profile (4 Fr) for placement of the lead even in difficult-to-access veins of varying sizes.

Fred Colen, executive vice president, operations and technology, in Boston Sci’s Cardiac Rhythm Management business, said, “Acuity Spiral has the smallest lead tip profile in the industry and offers physicians the flexibility to place the lead in veins they may have avoided in the past.”

Hatch brokering UK firm’s CTO device

Hatch Medical (Duluth, Georgia), a medical device incubator and technology brokerage firm, said it has entered into an agreement with Medical Miracles (Leeds, UK) to broker its CE-marked POLAR (Path Of Least Arterial Resistance) device for chronic total occlusion (CTO).

POLAR generates reciprocal and lateral movements at the distal end of standard guidewires with frequencies of 16 Hz to 100 Hz when passed through an angioplasty balloon catheter, allowing clinicians to confidently cross occluded vessels.

Hatch noted that percutaneous intervention of a CTO remains one of the more difficult technical challenges for interventional practitioners, “despite the progress made in the field of PI in the past decade.”

“Failure to revascularize a CTO often leaves the patient with either the more invasive option of bypass graft surgery or continuing medical therapy, which may or may not control their symptoms,” Hatch said, adding that neither is optimal.

The POLAR device is available for licensing or acquisition to interested third parties through an exclusive agreement with Hatch Medical.

Stem-cell lines set for German research

International Stem Cell (ISCO; Oceanside, California) said its human parthenogenetic stem cell lines will be used in Germany in studies aimed at creating specific cell types to treat human neural diseases such as Parkinson’s disease.

The work will be headed by Albrecht Mueller, MD, of the University of Wuerzburg (Wuerzburg, Germany) under a material transfer agreement between ISCO and the university.

“The fact that Dr. Mueller and the University of Wuerzburg have approved ISCO’s human parthenogenetic stem cells for research is a strong validation of their value in creating therapeutic cells that have significant immune rejection advantages and significant ethical advantages,” said Kenneth Aldrich, CEO and chairman of ISCO.