Medical Device Daily
and MDDs

The recently-troubled iSoft (Banbury, UK), now owned by IBA Health Group (Sydney, Australia), has won a contract valued at 5 million ($10.6 million) to provide health information technology and software throughout the next six years to the largest independent healthcare service provider in the UK.

General Healthcare Group (GHG; London) said it will license and implement iSoft's patient management systems (PMS) as part of an overhaul of IT systems and infrastructure at its 47 BMI Healthcare private acute surgical hospitals and its Netcare centers.

The iSoft PMS will streamline the patient administration processes, reduce the dependency on paper records and include core theatre and billing data into a single electronic record. This repository of information will form the basis of a patient's electronic health record for the GHG network of facilities.

The agreement provides for GHG to progressively receive the next-generation of iSoft products.

iSoft has a talent for announcing new versions of its software while primary care trusts with the UK's National Health Service (NHS) still are waiting for the first version of a patient management system that was promised for 2004.

E-Health Insider, an online journal that tracks the implementation of the NHS's ambitious 12 billion ($23.6 billion) Connecting for Health program, said that senior NHS IT staff at two iSoft pilot sites said that after much configuration, a limited version of the software called Lorenzo that eventually will power 60% of England's health IT program would be ready "during the summer period" for limited delivery to four NHS organizations. Those sites are in South Birmingham, Morecombe Bay, Bradford and Nottingham.

Winning the contract with GHG is a vote of confidence in the iSoft software packages and a sorely needed boost for the company that six months ago was the focal point for criticisms and threats of shutting down the Connecting for Health program (Medical Device Daily; Sept. 20, 2007).

For the year ended September 2006, GHG reported revenues of 644 million ($1.26 billion) and earnings of 149 million ($293 million) and spent more than $100 million each year expanding and improving care facilities.

At the end of 2006, GHG became part of Network Healthcare Holdings (Netcare; Sandton, South Africa), which owns or manages 71 hospitals and same-day surgical units in southern Africa comprising 9,285 beds, 358 operating theatres, 82 pharmacies and 61 specialized medical centers.

At the end of April at Healthcare Computing, the premier UK event for health IT, iSoft continued its string of new product announcements with the launch in England of i.Laboratory Enterprise, which is used in what the company says are "some of the largest distributed, integrated laboratory services in Europe."

Boston Sci's Altrua pacemakers CE-marked

Boston Scientific (Natick, Massachusetts) yesterday reported receiving CE-mark approval and giving market launch for its Altrua family of pacemakers.

The company says the Altrua is its most advanced pacemaker, delivering enhanced therapy with small size and battery longevity. It is the first Boston Sci-branded pacemaker to treat bradycardia — when the heart beats too slowly, usually less than 60 beats per minute.

"European approval of Boston Scientific's Altrua family of pacemakers is the latest example of the significant progress we have made rebuilding our CRM organization and reinvigorating our product pipeline," said Fred Colen, executive VP, operations and technology, CRM. He said the Altrua technology enables physicians "to adjust the therapy to meet the needs of their patients" and demonstrating "our renewed focus on treating bradycardia."

The company noted a variety of Altrua features:

• Multiple Atrial Ventricular (AV) Delay programming options, options designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats, "a key distinction from other competitive RV pacing algorithms." The Altrua 50 and 60 series include an enhanced AV search hysteresis feature, now with an extendable AV delay out to 400 milliseconds, providing additional flexibility to tailor device programming for unique patient needs.

• Minute Ventilation (MV) Blended Sensor, treating a condition called Chronotropic Incompetence, the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress. Boston Scientific says that its MV Blended sensor is the only sensor that has been shown to restore Chronotropic Competence.

• Ventricular Rate Regulation (VRR), which helps physicians manage patients with frequent atrial arrythmias.

• Automatic Capture, designed to offer automatic and accurate ventricular pulse management. The device checks every heart beat to see if the lower chambers of the heart contract in response to the delivered pulse. If no contraction is detected, a backup pace with more energy is delivered.

Altrua pacemakers are currently awaiting FDA approval.

Gore gets CE mark for Preclude Vessel Guard

W. L. Gore & Associates (Flagstaff, Arizona) said it has received CE-mark approval for sales of the Gore Preclude Vessel Guard, which it said is the first non-biological membrane indicated as a cover for vessels following anterior vertebral surgery.

The company said this advanced biomaterial "reduces the risk of potential vascular injury by providing a permanent and visible plane of dissection around the vasculature to facilitate anterior revision surgery."

The device "enables vasculature management in patients having undergone anterior spinal surgery for degenerative disc disease, including artificial disc replacement, where scarring around the aorta, vena cava and iliac vessels can complicate revising, repositioning, or removing a disc prosthesis."

Gore said the tight microstructured membrane is inserted between the prosthesis and the vessels during the primary surgery. In a revision surgery, the vessels can be identified, dissected from the device and mobilized.

The product has a three-layer construction, with two outer layers consisting of a tight expanded ePTFE microstructure, preventing penetration by fibroblasts and minimizing vascular tissue attachment to the device. The company said an elastomeric inner layer "minimizes impingement and provides the stiffness needed for accurate placement."