A Medical Device Daily

Percutaneous heart valve device maker Evalve (Menlo Park, California) reported that the first three patients have been treated with the MitraClip system at the University of Hull's Castle Hill Hospital in the UK.

The MitraClip system is the first commercially available device that provides a non-surgical mitral valve repair option for patients suffering from the effects of mitral regurgitation (MR), the most common type of heart valve insufficiency in Europe and the U.S., affecting millions of people worldwide.

Repair with the MitraClip device is performed by physicians in the cath lab. The heart beats normally during the procedure, and thus does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also may relieve symptoms such as fatigue and shortness of breath that can affect patients with significant MR.

The first UK patients were treated by a team led by Farqad Alamgir, MD, consultant cardiologist; Simon Thackray, MD, consultant cardiologist; Raj Nair, MD, cardiology registrar and Andrew Clark, MD, reader and honorary consultant in cardiology.

"This technology is cutting-edge and may transform the way many of our patients receive heart surgery," said Alamgir. "The MitraClip therapy reduces many of the risks and trauma currently associated with open heart surgery. I believe the MitraClip system will not only play a key role for non-surgical MR patients, but should also be considered as a therapy for select surgical candidates."

Evalve received CE-mark approval for the MitraClip system earlier this year and began commercial sales in Europe in September. The company has worked with hospitals across Europe to establish training programs in support of the European roll-out.

The MitraClip system is undergoing clinical evaluation in the U.S. and Canada.

"Suitable patients now have a less invasive therapeutic alternative to surgery for repairing the mitral valve," said President/CEO Ferolyn Powell. "The ... treatment of the first series of patients in the UK marks another notable milestone for those suffering from MR. We are pleased with the early acceptance and results of the MitraClip therapy and will continue to work to make the therapy available throughout the European Union."

Evalve is the first portfolio company from the medical device company incubator, The Foundry.

CE mark for VYOO sepsis test

SIRS-Lab (Jena, Germany) reported that European Union regulatory authorities have granted the CE mark for VYOO, a molecular diagnostic test for pathogen detection in sepsis. With VYOO, clinicians can rapidly and reliably identify causative pathogens as well as important antibiotic resistance markers. Therefore VYOO allows for a customized anti-infective therapy in each patient within the critical hours of treatment.

SIRS-Lab said receipt of the CE mark will accelerate the implementation of VYOO into clinical routine throughout Europe.

Sepsis, a life-threatening systemic infection, occurs in more than 2 million cases per year and is the second-ranked cause of death in hospitals after cardiovascular diseases.

SIRS-Lab, a leading molecular diagnostic company in the field of sepsis, has released VYOO in 2007. It said the cutting-edge pathogen detection test provides "significant advantages" over currently used methods in clinical practice.

CEO Dr. Stefan Russwurm said, "In important European clinical centers, for example in Paris or Basel, patients already benefit from the therapeutic advantages provided by VYOO. With the CE status, the full potential of this groundbreaking approach to sepsis diagnostics will be realized."

Partnership on imaging in UK

Acrobot (London), which specializes in computer-assisted orthopedic surgical navigation, and Alliance Medical (also London), part of the largest pan-European medical imaging company in Europe, supporting more than 400 hospitals and clinics in the UK, reported that they have entered into a partnership which will help improve surgical outcomes through the provision of advanced imaging techniques.

The deal will see Acrobot and Alliance Medical collaborate to provide orthopedic surgeons with an integrated process from CT scanning through to navigated joint replacement that can influence clinical outcomes.

The companies said the availability of such a process "mak[es] life easier for the surgeon and better for the patient."

Alliance operates CT scanners in central London via its Alliance Medical Imaging Centres London division. These produce data using Acrobot's Modeller software, allowing Alliance to create 3-D models of patients' anatomy – the essential building block of the process.

Once the 3-D model is created, surgeons have the option to create "Patient Plans" on an ordinary laptop or desktop PC. "These plans can be used to provide detailed component sizing and position using Acrobot's Planner software and, if desired, the surgeon can take this plan into theatre and reproduce it accurately and reliably using Acrobot Navigator."

Acrobot CEO Graeme Brookes said, "Advanced imaging and modeling has been shown to have a significant effect on surgical outcomes. When orthopedic components are implanted accurately and successfully, the patient's post-operative recovery time can be reduced and discomfort and complications can be minimized."

The agreement will enable more surgeons to access Acrobot's Navigator system: technology that is now usable in a wider range of procedures including uni-condylar knee and total hip replacements. This distribution arrangement is Acrobot's first commercial route-to-market agreement using Modeller.

Elaine Head, head of Alliance Medical Imaging Centres London, said, "We are delighted to be working with Acrobot. Our centers provide easily accessible medical diagnostic modalities to thousands of people and we are keen to be able to bring new techniques like Acrobot to a wider patient base in the future. Acrobot has so many benefits for our referring surgeons and we are proud to be leading the development of its clinical practice."