A Medical Device Daily

Abiomed (Danvers, Massachusetts) reported receiving the CE mark for its Portable Circulatory Support Driver, allowing sale of the device in the European Union countries as well as many other countries worldwide that accept that approval. The Portable Driver supports Abiomed's AB5000 Ventricular Assist Device (VAD) for both in-hospital and out-of-hospital patients.

The AB5000 Portable Driver is lightweight and quiet, "demonstrates reliable performance," Abiomed says, "and has the potential to improve patient care while lowering costs to hospitals." The company said the device "provides patients requiring VAD support a greater degree of mobility and improved quality of life during treatment aimed at myocardial recovery."

The driver weighs 18 pounds and is "the lightest and most powerful bi-ventricular system in the industry," according to the company, delivering pressures and vacuums equivalent to its AB5000 console and the recently approved iPulse combination console. It said internal that testing showed that the Portable Driver is capable of providing full support for a year's intended use.

The unit is expected to require low maintenance, roughly every 5,000 hours of operation, estimated as three times longer than existing portable consoles that Abiomed said "weigh twice as much or more."

The company said the Portable Driver was designed with the latest "smart battery" technology for extended power. "The quiet operation of the Portable Driver provides for minimal disruption of the patient's quality of life at home," said Abiomed, which recently reported FDA labeling approval of one-year bench reliability for its AB5000 VAD, expected to complement the Portable Driver reliability.

"There is a clinical and financial demand for a highly reliable mobile driver that allows for patient discharge," said Michael Minogue, president/CEO and chairman of Abiomed. "We are now offering a complete portfolio of circulatory care products that help the heart recover, from the cath lab to the surgery suite to the ICU to home discharge."

The AB5000 VAD is CE-marked, and Abiomed said it has supported patients for up to 312 days. The Portable Driver is expected to enhance the company's bridge-to-transplant opportunity.

Health Care Without Harm raps EU report

The conclusions of an EU report on the safety of DEHP, a common additive to medical devices, are "fundamentally out of step" with many hospitals' rationale for materials selection when purchasing medical devices, according to Health Care Without Harm Europe (HCWHE).

The report, published by the EU Scientific Committee for Emerging and Newly Identified Health Risks (SCENIHR), "is correct to identify vulnerable groups, especially male infants, as 'at risk' of suffering adverse health effects when treated with medical devices treated with DEHP," said HCWHE.

It said that the SCENIHR report was weakened by a too-narrow interpretation of its remit, and the committee failed to examine plasticizer-free plastics used in alternative medical devices. Only plasticizers used as alternatives to DEHP were investigated, it said.

"Responsibility for the remit of the SCENIHR report lies with DG Enterprise in the European Commission, an entity not well-known for its support of the alternatives industry," WCWHE said.

Lisette van Vliet, EU policy advisor for the organization, said, "The most disappointing aspect of the report is SCENIHR's failure to investigate the safety of alternative plastics for medical devices. These are widely available on the European market, have passed the required tests and are already in use by a number of hospitals wanting to altogether avoid the health issues and uncertainties around plasticizers."

"Since [more than] 60 European hospitals are engaged in PVC phase-out projects, there is a reasonable likelihood that EU reports on DEHP and alternative plasticizers will be made redundant by a market shift toward alternative materials, driven by hospitals concerned with patient care issues rather than industry protecting its sales of PVC medical devices."

Transoma expands HealthLink Europe accord

HealthLink Europe (Tilburg, the Netherlands) said it has expanded its customer service and logistical services relationship with Transoma Medical (St. Paul. Minnesota) on behalf of its Data Sciences International (DSI) division, whose customers are research labs found in academic and government institutes and "nearly every major pharmaceutical company."

Kristi Lloyd, logistics manager for Transoma, describing itself as "pioneering technologies that are transforming how physicians gather cardio, vascular and other vital patient data in real-time," said, "HealthLink now is providing us with a full complement of customer service/sales-and-marketing support functions. HealthLink manages our European orders, talks to our customers, facilitates returning product from our European customers, and invoices our customers. HealthLink "is our fiscal representative in Europe."

Transoma manufactures implantable, subcutaneous, wireless diagnostic and monitoring products. Its DSI unit is a supplier of wireless, physiologic monitoring equipment and related data acquisition and analysis products used in biomedical research, including pre-clinical drug discovery and development.

HealthLink is an ISO 13485 device support services and distribution company that has provided European customer service and logistics support to the North American device industry since 1994.

Swedish NPO to use InterSystems' software

InterSystems (Cambridge, Massachusetts) reported that the Swedish national electronic health record, the National Patient Overview (NPO), will be supplied by TietoEnator (Espoo, Finland) using InterSystems HealthShare software. The contract is valued at about $19 million for the first five years, with an option to extend for an additional two years.

The NPO is designed to enable the sharing of patient information between regional and local care providers in both the public and private sectors. In a competitive procurement, the Swedish Healthcare Advisory Organization chose TietoEnator as prime contractor to deliver the development, implementation and hosting of the NPO.

InterSystems is a platform that will play a role as the core software with which the NPO will be delivered. The solution is expected to be ready for production within 12 months.