A Medical Device Daily

Jarvik Heart (New York) reported that it has received CE mark certification for the Jarvik 2000 FlowMaker, a small left-ventricular assist device (LVAD) used to treat severe congestive heart failure, allowing its commercialization in Europe.

The company said the certification not only makes the Jarvik 2000 more widely available to patients, but available to patients at earlier stages of heart failure.

The Jarvik 2000 is a thumb-sized titanium pump designed to be implanted inside a weakened, failing heart to boost its output of blood to the body. It has been used to treat more than 100 patients worldwide over the past five years and, according to the company, has had “high rates of success both as a bridge to transplant and for lifetime use.”

The CE mark applies to the Jarvik 2000 for both indications. The company said that means severe heart failure patients and their doctors in Europe can choose the device as an intervention before the disease takes an irreversible toll on patients’ bodies and other organ systems.

Jarvik Heart said the device will be used more often with patients who are outpatients at the time the decision is made to implant the device. “Earlier treatment is expected to benefit patients’ health, quality of life and chances of survival,” it said.

The company said the Jarvik 2000 FlowMaker has given extremely sick patients “a near-normal quality of life,” has shown low rates of infection compared to other approved LVADs, and has had no mechanical bearing failures to date.

Its external components, including a battery and pump controller, are ultra-portable, Jarvik Heart said, weighing about a kilogram. The implanted device itself weighs only 90 grams and slips inside the left ventricle, allowing the heart to continue to fill with and eject blood.

“With their natural heart intact, Jarvik 2000 patients do not feel the device at work, they retain a pulse, and they often have recovery of their own heart to some degree,” the company said. “Their quality of life approaches the ideal for this type of mechanical circulatory support device: ‘forgettable’ use by the patient.”

Jarvik Heart said the first patient to receive the Jarvik 2000 for lifetime use is active and in good health almost five years after implantation. He is the longest surviving patient in the world continuously supported by any type of mechanical heart.

The company said it would be seeking to partner with “exceptional” medical centers throughout the European Union to make the Jarvik 2000 FlowMaker available to patients who can most benefit from it.

Robert Jarvik, MD, inventor of the Jarvik 7 and Jarvik 2000 mechanical hearts, is president and CEO of Jarvik Heart. Leon Hirsch, founder and former chairman of U.S. Surgical (Norwalk, Connecticut), now a Tyco Healthcare (Mansfield, Massachusetts) company, serves as chairman of the board.

Qlik Tech group wins large German contract

QlikTech (Lund, Sweden) and Intel (Santa Clara, California) reported that the Kassenarztliche Bundesvereinigung (KBV; Duesseldorf, Germany), the umbrella organization for 17 physicians’ associations in Germany, has selected QlikView to simplify analysis for the implementation of recent German government healthcare reforms.

QlikView runs on the 64-bit Intel Itanium 2 processor platform. A combined QlikTech, Intel, Microsoft (Redmond, Washington) and HP (Palo Alto, California) team collaborated to win the KBV’s business over legacy business intelligence solutions.

Recent healthcare reforms in Germany require the KBV and other associations of physicians to provide their association members with both summary key performance indicators and record level detail of patient outcomes. The law now requires the KBV to analyze anonymous patient outcome data quarterly, by individual case, patient and diagnosis.

The companies said that after an extensive evaluation, the KBV concluded that the 64-bit version of QlikView running on the Itanium 2 processor platform was the only solution capable of analyzing the required 15 terabytes to 20 terabytes of data without the use of a data warehouse.

Three suppliers took part in a technical feasibility study, and the KBV decided in favor of the QlikTech group. QlikTech, HP Germany and the HP distributor, Computer Center, were able to deliver and install the first test QlikView analysis application in one day. The application analyzed about 300 million records from four German physicians’ associations.

QlikView analyzes huge amounts of data at high speed by loading data directly into memory. It can provide summary level metrics and record level detail on the same architecture.

At present, the QlikView solution is being used in the central KBV office and in a regional office in Mecklenburg-West Pomerania. “If the system is accepted as well in the other regional offices as it has been here, then it could very well be expanded to all 17 regional offices in Germany,” said a KBV official.

The KBV Accounting Department is now planning to use QlikView to create a number of different business analysis applications for the individual departments and regional offices.

The manages the National Register of Physicians and also concludes contracts with the top associations for the compulsory health insurance agencies and other institutions paying social benefits in Germany.

Besides its headquarters in Sweden, QlikTech has subsidiaries in the U.S, UK, Germany and elsewhere in Scandinavia.