A Medical Device Daily

Some €95 million in funding will go to UK Primary Care Trusts (PCTs) that offer a choice of hospital treatment to National Health Service (NHS) patients through the electronic “Choose and Book“ system.

The new package of funds, to be spent over a two-year period, is expected to speed up the implementation of the UK government's commitment that by the end of this year, all patients will be offered a choice of four or five providers, including the independent sector, when they are referred by their general practitioner (GP) for a specialist appointment.

Health Secretary John Reid said during a speech to the New Local Government Network in London last month that the funds would be paid in stages to PCTs as GP practices installed computer systems to enable them to offer an electronic menu of choices to patients.

“Being able to choose and book hospital appointments at the family doctors is a crucial factor in delivering choice,“ Reid said. “We have implemented the choice' information technology program in stages. First we procured the equipment, second we made sure it worked, now we know the challenge is to roll out the service across the NHS.“

He said that more than 2,500 GPs already have been involved in developing systems to support choice and booking, adding that such involvement “will increase during this important next stage of implementation.“

The three-stage program includes incentives first being available to PCTs when family doctors install the “Choose and Book“ system and offer choice menus to their patients.

The second stage, Reid said, “will be when they actually use the system with their patients for 50% of their hospital referrals — by no later than the end of October.“

The third stage will be when family doctors use the system to offer 90% of patient referrals once the system is fully implemented in 2006.

Swedish firm gets FDA clearance

Radi Medical Systems AB (Uppsala, Sweden), a manufacturer of innovative devices in interventional cardiology, reported the FDA 510(k) clearance of its newest product, RadiAnalyzerXpress. Along with the recently released PressureWire5 Sensor, they make up an easy-to-use system for measurement of Fractional Flow Reserve (FFR).

The RadiAnalyzerXpress system is a lightweight, flat-panel instrument designed for ease of use. Using an on-screen guide with step-by-step instructions, instrument setup is quick and intuitive, the company said. Radi said the PressureWire5 Sensor has “excellent overall mechanical maneuvrability, pushability and a tip design with improved shape retention, valuable during long and complex procedures.“

Lars Tenerz, vice president of R&D, said, “Radi, which invented the guidewire-mounted pressure senor for FFR measurement, continues to lead the way. Customer feedback confirms our belief that the system's improved features and user friendliness has made it a far more efficient tool for clinical decision-making.“

He said the company's customers “are clear that we have a very robust new system that works reliably in the cath lab environment.“

Radi said its physiology platform is the only system on the market that provides measurement of pressure, flow and intravascular temperature using a single PressureWire5 Sensor and one instrument. It said all data is easily transferred to a PC for research and storage.

Sale of the RadiAnalyzerXpress and PressureWire5 Sensor in the U.S. will begin immediately.

GSK licenses device/drug system

Transport Pharmaceuticals (Framingham, Massachusetts) has granted access to its iontophoretic device/drug combination system to GlaxoSmithKline (GSK; London) for the delivery of acyclovir, an approved cold sore treatment.

GSK received exclusive rights to market and sell the system in Europe, Australia, Latin America and South Africa, where acyclovir cream is marketed as an over-the-counter product.

In exchange, Transport is receiving an up-front license fee, as well as milestone and royalty payments. GSK will provide technical support and contribute to certain costs of upcoming European Phase III trials.

Transport's platform is based on iontophoresis, which uses a low-voltage electrical charge to increase skin permeability in order to locally deliver medication through the skin. The company has developed a small, wireless computer-controlled electrode and medication applicator that will allow patients to self-administer topical drugs for a variety of indications.