A Medical Device Daily

CoreValve (Paris) said this week that its percutaneous ReValving System, which features a pericardium aortic heart valve mounted in a self-expanding frame, has been implanted successfully for the first time in Europe in the cardiac catheterization laboratory at The Heart Center (Siegburg, Germany). As a result, the 73-year-old female patient was able to avoid open-heart surgery to treat her aortic calcified stenosis.

The system for percutaneous heart valve replacement is based on a catheter-and-self-expanding-stent approach on a beating heart that can be conducted in a cath lab, just like angioplasty and stenting.

The ReValving procedure was performed by noted interventional cardiologist Eberhard Grube, MD, chief of cardiology and angiology at The Heart Center and a consulting professor of medicine at Stanford University (Palo Alto, California).

Grube's patient was the first in a European clinical feasibility trial of the CoreValve ReValving System that will non-surgically replace diseased aortic heart valves in a total of 20 patients who are at an increased risk for open-heart surgery.

“Our patient . . . improved immediately following the implant,“ said Grube. “Her cardiac output increased from 1.2 liters per minute to 2.5 liters per minute, and her left ventricular ejection fracture improved remarkably — from 45% to 72% — immediately following the ReValving procedure.“

He said he “strongly believes“ that the ReValving approach “has universal applicability and will allow patients to avoid open-heart surgery by non-surgically treating both forms of aortic valve disease — stenosis and regurgitation.“

Jacques Seguin, MD, PhD, chairman and CEO of CoreValve, said, “The commencement of the European leg of our clinical trial strategy is another milestone for CoreValve, because inclusion of leading European investigative institutions such as The Heart Center can be expected to accelerate adoption of [the] ReValving technology as the next-generation cath lab therapy for interventional cardiology.“

Seguin, himself an internationally known interventional cardiologist, said CorValve “remain[s] on schedule for the start — before the end of summer — of our pivotal trial toward CE-marking.“

Privately held CoreValve has operations facilities in Irvine, California, in addition to its Paris headquarters.

NHS to reward for extra work

An initiative to reward doctors and other staff for carrying out extra work is to be rolled out further across the UK's National Health Service (NHS), according to Health Minister John Hutton.

The Fee for Service program involves consultants and other staff receiving bonus payments for the surgical procedures or other treatments they perform on top of the volumes they would normally be expected to carry out.

Hutton said the plan will mean new ways of working, leading to thousands of NHS patients having their operations more quickly and helping the NHS work toward its 18-week target covering the period from referral to treatment.

He said the plan also would be piloted for the first time in the diagnostic sector to help speed up diagnostic tests.

The Fee for Service plan has been piloted in 32 NHS trusts since last October. The pilot programs involved 400 doctors and other clinical staff and set a target of 8,000 additional operations and 6,000 outpatient consultations. A report undertaken for the Department of Health found that the program is expected to deliver these targets by the end of March and, in the case of inpatient activity, to exceed the target by delivering more than 8,400 additional surgical procedures.

Hutton's announcement included:

  • Funding of £500,000 to the most successful pilot sites to spread best practices as part of the drive to extend Fee for Service models throughout the NHS.
  • An additional group of sites to be included within the pilot program — including North Middlesex University Hospital NHS Trust, Royal Orthopedic Hospital NHS Trust, North Tees and Hartlepool NHS Trust, and East Elmbridge and Mid Surrey PCT.
  • Identifying six sites to pilot Fee for Service in diagnostics during 2005-2006, with the possibility of extending that effort further at a later date.

The Department of Health said hospitals participating in the program are using Fee for Service to help transform the way patient care is delivered, improve efficiency and create extra capacity. The effort covers a range of treatments, including orthopedics, ophthalmology and general surgery.

Program eyes roadside drug testing

Avitar (Canton, Massachusetts) is participating in the ESTHER (Evaluation of oral fluid Screening devices by TISPOL to Harmonize European police Requirements) project, coordinated by TISPOL, the European police traffic network.

TISPOL is organizing the ESTHER project to standardize roadside drug-testing practices in European countries. Over the course of about a year, TISPOL participants will outline a standard procedure for roadside drug tests.

“Drugged driving is an issue of growing concern worldwide,“ said Peter Phildius, CEO Avitar CEO. “Because of its ease of use and rapid results, our ORALscreen Drugometer test lends itself extremely well as a tool for roadside drug tests.“

He said his company “appreciate[s] the opportunity to play a role in helping police departments across Europe determine viable methods to reduce the incidences of drugged driving.“

Participating traffic police forces include those from Northern Ireland, the Republic of Ireland, the United Kingdom, France, Belgium, Spain, the Netherlands and Slovenia.

Within the scope of the TISPOL project, operational requirements and specifications will be obtained under police conditions as part of normal traffic enforcement activities and surveillance. Authorities will stop traffic offenders and use oral fluid-based drug tests at roadside to screen for illegal drug use.

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