A Medical Device Daily

Medtronic (Minneapolis) reported receipt of the CE mark for what it said is the first-ever MR-Conditional pacemaker system, which includes its EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads (Model 5086MRI).

The new system was approved for use with magnetic resonance imaging under specified scanning conditions, and is now commercially available in select European countries, the company said.

Patients receiving the EnRhythm MRI SureScan Pacing System will for the first time be able to undergo MRI scans under certain conditions, Medtronic said, "representing a major milestone in the evolution of implantable cardiac devices."

Alain Coudray, MD, vice president of Medtronic's Cardiac Rhythm Disease Management business in Western Europe, said, "MRI is an invaluable medical diagnostic tool for many common diseases and conditions that, until now, patients with implanted pacemakers have been prohibited from receiving."

Noting what he termed "the complex needs of today's patient," he said the company "will continue to develop advancements in pacemaker technology and other devices that allow patients to receive optimal medical care."

Medtronic said that roughly 2 million Europeans have implanted pacemakers, but "these patients are prohibited from receiving MRI scans, a widely practiced diagnostic method for many common diseases and conditions, because their device could interact with MRI machines, potentially affecting the device or patient safety."

The company cited estimates that 50% to 75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

Medtronic added: "The EnRhythm MRI SureScan pacing system has undergone extensive research and design efforts to address and mitigate interactions between the pacing system and the MR environment. The system includes modified hardware to minimize the level of energy transmitted through the lead/device connection point."

The new system also includes a new SureScan feature designed to eliminate the impact of MRI-generated electrical noise, as MRI scanners may cause traditional pacemakers to misinterpret this noise and as a result withhold or deliver unnecessary pacing therapy, the company said.

Medtronic said the device and leads also contain radiopaque marks, viewable via X-ray, to indicate that the system is MR-Conditional, a classification indicating a medical device may be used in the MRI suite under certain conditions.

It said the CapSureFix MRI SureScan leads "are designed to decrease the risk of overheating during an MRI scan without limiting the ability to conduct therapy."

Medtronic said safety and efficacy data on the system presented at the late-summer European Society of Cardiology (Sophia Antipolis, France) congress "showed no MRI-related complications, and no arrhythmia or asystole [absence of electrical activity in the heart] during MRI scans conducted on patients in a worldwide clinical study."

New system for MRSA, other screenings

Smiths Detection (London) said it is developing a rapid diagnostic system, initially for use in hospital screening programs for infectious diseases such as MRSA and Clostridium difficile.

The company said the Bio-Seeq system will provide easy-to-use tests suitable for either a laboratory or point-of-care setting where it can be operated by non-specialist staff. Clinical trials are expected to start early next year.

The technology platform, for which Smiths Detection expects to provide a wide range of tests, is based on the Bio-Seeq portable veterinary laboratory, which is due to undergo field trials for foot & mouth disease testing with the UN Food and Agriculture Organization later this year.

Using the clinical diagnostic version of Bio-Seeq, the patient sample is introduced into a disposable Sample Preparation Unit, which is then placed on the instrument. The company said no manual sample preparation steps are needed and the unit can process a variety of solid and liquid samples making it ideally suited for combating healthcare-associated infections which kill thousands of patients each year.

A Reagent Pack, inserted into the Sample Preparation Unit, contains all the components for the specific test and includes a bar code used to set up the instrument, further reducing the operator input required. It is anticipated that Reagent Packs for a wider range of tests will be developed, either by Smiths Detection or selected development partners.

The tests will use the LATE PCR technique licensed from Brandeis University (Waltham, Massachusetts) to amplify and analyze the genetic material of the infectious agent. The power of LATE PCR will be used to detect multiple diseases in each test, and to provide clinically important information such as antibiotic resistance and genetic mutations.

Stephen Phipson, group managing director of Smiths Detection, said: "Our ability to transform sophisticated laboratory technologies into reliable, easy-to-use detection systems is one of our key skills. Applying this to clinical diagnostics is a logical step for us."

Bill Mawer, head of Smiths Detection's newly formed Diagnostics business unit, said, "We are developing a powerful, flexible platform suitable for a wide variety of diagnostic tests and are keen to make that platform widely available."

Smiths Detection is seeking partners to co-develop a wide range of tests to run on the Bio-Seeq system.

NHS approves study of BT Test

Provista Life Sciences (PLS; Phoenix) said that the UK National Health Service's Ethical Committee approval has been granted to proceed with a validation study of its Biomarker Translation Test (BT Test) in the UK.

The BT Test, a new blood test developed by Provista Life Sciences to aid healthcare providers in early breast cancer detection, will undergo a validation study in the UK. The BT Test evaluates multiple cancer-related proteins in the blood and combines the results with a brief patient medical profile to help physicians in their efforts to find breast cancer as early as possible.

Clinical research conducted on the BT Test showed an accuracy rate above 80% for all women. The BT Test is designed to be used in conjunction with mammography and other diagnostic imaging procedures as part of a comprehensive breast cancer screening effort to assist healthcare providers in detecting breast cancer earlier.