A Medical Device Daily

BridgePoint Medical (Minneapolis) reported that it received the CE mark for its coronary and peripheral Chronic Total Occlusion (CTO) Crossing System comprised of the CrossBoss CTO Crossing Catheter and the Stingray CTO Re-Entry System. The BridgePoint System is a series of interventional catheters that are designed to navigate highly diseased arteries in preparation for blood flow restoration via angioplasty and stenting.

The National Heart, Lung and Blood Institute (NHLBI) estimates that CTOs are common and are found in about one-third of patients who undergo angiography, which equates to a world wide annual incidence of 1.3 million patients. Interventional cardiologists are currently unable to broadly treat patients with chronic total occlusions due to the procedurally challenging and advanced nature of the disease. For these patients, alternatives include bypass surgery or pharmacologic therapy. For the millions of people with living with a coronary CTO, chest pain, shortness of breath and fatigue are part of every day life.

"We have seen many attempts to implement new tools for the treatment of chronic coronary occlusions over the years, but until now none of them have provided any advantage over the current treatment of using specialty guidewires," said Gerald Werner MD, PhD, Professor at the Klinikum Darmstadt (Darmstadt, Germany). "This system is the first to provide a new option for the frequent situation when our guidewires do not reach the vessel beyond the occlusion. The BridgePoint system makes it possible to find the true vessel lumen and conclude the treatment successfully."

The disposable BridgePoint Catheter System does not require the use of expensive and cumbersome capital equipment and uses techniques that are common in interventional medicine.

"The CrossBoss and Stingray devices provide interventionalists in the E.U. with new opportunities to treat patients with highly diseased arteries. We believe that these devices represent an important new advance in interventional cardiology," said Chad Kugler, co-founder, president and GM, BridgePoint Medical. "This technology exemplifies BridgePoint's innovative approach to CTO treatment and our commitment to further reduce the need for invasive bypass surgery."

The BridgePoint Medical CrossBoss and Stingray are indicated in the European Union for adults with coronary or peripheral artery disease, age 18 and older. The devices are contraindicated for use in cerebral vasculature.

Roche, Junta de Andaluc a to collaborate

Roche (Basel, Switzerland) and the Department of Health of Junta de Andaluc a, Spain have signed an agreement for a cooperation in the Medical Genome Project (MGP), a research project created to analyze the genomes of people with rare diseases and identify the defective gene or genes causing the disease and its behavior. Roche will contribute 14 million Euros to the MGP; in exchange, Roche reserves the right of first refusal over any possible license regarding discoveries made within the scope of the project.

The project, initiated by the Junta de Andaluc a Department of Health, will begin in 2010 and extend to 2013. The research will take place in the Scientific and Technical Complex Cartuja 93 (Seville) and will be lead by Shomi Bhattacharya, PhD, and Guillermo Anti olo, MD, Associated Director and Director of the Andalusian Genetic Plan and Dr. Joaqu n Dopazo, Associated Director of Bioinformatics in the Andalusian Program for Genetic Research and Genomics.

In the first phase, the research project will concentrate on defining the whole variability of human genes and will work with about 300 DNA samples, each of which can contain up to 26,000 different genes. Once the genetic variability has been defined, it will be compared with the genetic alterations observed in rare diseases to identify the causal gene or genes of thousands of these conditions.

In the final phase, the project will concentrate on the search for specific therapies for genetic-based diseases, in the field of personalized healthcare. The approach of personalized healthcare is to use new molecular insights and molecular diagnostic tests to better tailor medicines and better manage diseases. Roche aims at tailoring medicine as closely as possible to patients' needs.

"Roche is committed to personalized healthcare based on the scientific advances that have been made over the last decade in regard to the genetic and molecular basis of diseases, as well as the response to drugs and their variability depending on each individual", said Juergen Schwiezer, CEO of the Roche Diagnostics Division.

Luxembourg hospitals order Sectra MicroDose

Women in Luxembourg will soon be benefiting from low-dose mammography. Three hospitals in Luxembourg have ordered Sectra's (Linköping, Sweden) MicroDose Mammography after evaluating experiences from other European countries.

At Centre Hospitalier du Luxembourg, Zitha Klinik Luxemburg and Hospital St. Louis Ettelbruck, women participating in the national screening program will now be offered mammography at the lowest possible dose.

The national breast screening program in Luxembourg, established in 1992, covers all women aged 50 to 69 and has a participation rate of 64%.

"Care quality awareness is increasing among our customers, and the Luxembourg screening program is well-known for its high standards of mammography, which makes this a great reference," said Peter Osinga, Managing Director Sectra Benelux.

At the same time, the radiation to which the women are exposed is minimized to the lowest conceivable level. Sectra MicroDose Mammography is based on a unique detector technology that counts each X-ray photon. This is the X-ray technology of the future.

Sectra develops and sells IT-systems and products for radiology, mammography and orthopaedic departments. More than 1,000 hospitals worldwide use the system daily, together performing over 50 million radiology examinations annually. This makes Sectra one of the world leading companies within systems for handling digital radiology images (PACS). In Scandinavia, Sectra is the market leader with more than 50% of all film-free installations. Outside Scandinavia, Sectra's system is installed at customers in North America and most major countries in Europe and the Far East.