A Medical Device Daily

Medtronic (Minneapolis) reported receiving a Medical Device License from Health Canada to sell its Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System in that country.

The company said the system is the first of its kind in North America to treat patients with congenital and acquired structural heart disease requiring pulmonary valve replacement.

Oern Stuge, MD, president and senior VP of the Cardiac Surgery business of Medtronic, termed the approval a significant milestone for this system, designed to reduce the number of times that certain patients may need to undergo open heart surgery by providing a minimally invasive, catheter-based solution to valve replacement. He added: “[W]e are pleased that patients in Canada will now be able to benefit from this less-invasive approach to valve replacement.”

The Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System are designed to treat congenital heart defects involving the connection between their right ventricle and pulmonary artery.

Medtronic said this type of defect often requires open-heart surgery early in life to implant a prosthetic valved conduit to establish adequate blood flow from the heart to the lungs. “However, the functional life span of these conduits is relatively limited,” the company said, “and as a result most patients with this type of defect are committed to multiple open-heart surgeries over their lifetime.”

The Melody valve and Ensemble system provide a non-surgical means to restore valve function and prolong the life of prosthetic conduits, thus reducing the number of open-heart surgeries required for these patients.

According to the American Heart Association (Dallas), congenital heart defects are the No. 1 birth defect worldwide. In Canada, congenital heart defects occur in one of every 100 babies, and more than 20% of these defects involve the pulmonary valve.

Medtronic said more than 190 patients worldwide have been implanted with the Melody valve. Lee Benson, MD, an interventional cardiologist at the Hospital for Sick Children (Toronto) and Dr. Eric Horlick, at the University Health Network, Toronto General Hospital, were the first in North America to implant Melody valves under special access permission from Health Canada in 2005.

The Melody Valve and Ensemble System received CE-marking in September 2006 but is not yet available in the U.S.

U.S. okays TheraSphere for HCC patients

Global medical isotopes and radiopharmaceuticals provider MDS Nordion (Ottawa, Ontario), whose products are used to diagnose and treat disease, reported FDA approval of TheraSphere to treat those with hepatocellular carcinoma (HCC) who have partial or branch portal vein thrombosis and have been identified as suitable candidates.

HCC is the most common form of primary liver cancer, while portal vein thrombosis is a blockage, by a blood clot, of the portal vein, which brings blood to the liver.

MDS Nordion said TheraSphere is the first medical device approved in the U.S. to treat primary liver cancer patients with this condition. The expanded use extends the current approval of TheraSphere as a Humanitarian Use Device for the treatment.

The company said that treating HCC patients using traditional therapies “is often difficult or impossible,” and that some treatments can slow or even stop blood flow.

It said that unlike conventional therapies, Therasphere does not significantly alter blood flow to the liver and tumors. “With this treatment, small radioactive glass beads attack cancerous tumors in the liver, while minimizing the impact on the patient’s healthy tissue,” according to MDS Nordion.

TheraSphere is a low-toxicity, outpatient therapy consisting of millions of micro-glass beads containing radioactive yttrium-90. It is injected into the main artery of the patient’s liver through a catheter, enabling the treatment to be delivered directly to the tumor via blood vessels, with few side effects.

“We are [pleased] about providing physicians with new tools to help in their ongoing fight against cancer,” said Steve West, president of MDS Nordion. “This expanded use for TheraSphere provides physicians with a new treatment option and hope for patients with primary liver cancer.”

Last September, MDS Nordion reported that it had received FDA approval to move forward with clinical trials to test the effectiveness of TheraSphere in patients with secondary liver cancer.

Fresenius buys majority in Taiwanese provider

Fresenius Medical Care (Bad Homburg, Germany) continues to expand in Asia, reporting the acquisition of a 51% equity interest in Jiate Excelsior (Excelsior; Taipei, Taiwan) for $38 million.

With a market share of some 14%, Excelsior is the largest dialysis service provider in Taiwan, treating more than 6,500 hemodialysis patients in 90 clinics.

The transaction is expected to add about $84 million to Fresenius’ consolidated revenues and to be accretive to the company’s earnings for 2007. The acquisition is subject to the approval of the Taiwan government’s Investment Committee.

At the end of 2005, there were nearly 45,000 end-stage renal disease (ESRD) patients in Taiwan. The country has experienced about a patient growth of about 6% annually in recent years, with a prevalence rate (patients per 1 million population) exceeding 1,900 – the second-highest such rate worldwide.

Fresenius Medical Care’s share in the number of treated patients in Taiwan will increase from 4% to about 18%. Through the transaction, the German firm will become the leading dialysis provider in the Asia-Pacific region and will provide dialysis services to more than 10,000 patients.

Ben Lipps, CEO of Fresenius, said, “We are pleased to further expand our strong product and services base business in Asia. We now have achieved leadership in products and services in all of our key global regions.”

Excelsior was established in 1998 and is wholly owned by Enfield Medical. The company operates and manages dialysis units in hospitals as well as stand-alone clinics.

Fresenius bills itself as the world’s largest integrated provider of dialysis products and services to treat chronic kidney failure, providing treatment to 161,433 patients through a network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa.

It also is the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.