A Medical Device Daily

Medtronic (Minneapolis) said it has received the CE mark for its second-generation pacemaker designed for use as labeled with MRI machines, the Advisa DR MRI SureScan pacing system.

About 2 million Europeans have pacemakers implanted, but those patients are strongly discouraged from receiving MRI scans because their device could interact with MRI machines, potentially affecting the device or patient safety. According to estimates, 50% to 75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

"Previously, physicians had been forced to forego the benefits of MRI, or accept the significant risk associated with scanning device patients," said Pat Mackin, president of the company's Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "[This system gives] physicians a solution to this unmet need – in fact a choice of devices for their pacemaker patients who may need access to important diagnostics available through MRI."

The Advisa MRI SureScan pacing system is the most advanced pacing system from Medtronic and combines for the first time MRI SureScan with key features from Medtronic pacemakers and defibrillator systems such as MVP (Managed Ventricular Pacing), OptiVol Fluid Status Monitoring, and Ventricular and Atrial Capture Management (VCM and ACM).

MVP reduces right ventricular pacing by 99%. The company said that iIn SAVE PACe, a previous trial of pacemaker patients published in the New England Journal of Medicine, showed that use of Medtronic MVP or Search AV+ modes was proven to "dramatically reduce" unnecessary right ventricular pacing. VCM and ACM are intended to automatically adjust impulses for optimal stimulation of the heart's chambers.

Upon commercial release, the Advisa MRI SureScan pacing system will be available for remote follow-up via the Medtronic CareLink Network.

1st EMS buyer for new Zoll system

Zoll Medical (Chelmsford, Massachusetts), a maker of resuscitation devices and related software solutions, said the ambulance service, RAV Gooi en Vechtstreek (Hilversum, the Netherlands), is the first EMS organization to equip its ambulances with what the company terms "a revolutionary new system" that allows rescuers to defibrillate a heart without the need to stop chest compressions.

Zoll said the real-time integrated operation of the new AutoPulse Plus and the E Series coordinates the ability to provide consistent, uninterrupted chest compressions with timed shock delivery.

Integrating these two therapeutic interventions into a seamless rescue effort has long been viewed as critical to advancing resuscitation care. Stopping chest compressions during defibrillation results in a rapid fall in coronary perfusion pressure.

Both the AutoPulse Plus and the E Series have the CE mark.

"Our evaluations of this integrated system demonstrated that we are able to maximize the likelihood of shock success and minimize no flow time," said Frank Berg, manager of operations at RAV Gooi en Vechtstreek. "This technological solution could be significant to improving outcomes from sudden cardiac arrest."

"Avoiding interruptions in defibrillation is among the highest priorities in resuscitation care. With timed shock delivery, which is the ability to deliver the treatment at the optimum time during the compression cycle without stopping CPR, another important step forward in improving survival from sudden cardiac arrest has been taken," said Jonathan Rennert, President of ZOLL.

Zoll said that like the current AutoPulse, the AutoPulse Plus "helps provide the consistent, uninterrupted chest compressions called for by the European Resuscitation Council Guidelines." It said the automated, portable device has "an easy-to-use, load-distributing LifeBand that squeezes the entire chest, improving blood flow to the heart and brain during sudden cardiac arrest."

According to the company, the AutoPulse offers a "significant advantage" over manual CPR because it moves more blood, more consistently, than is possible with human hands. "AutoPulse delivers high-quality, uninterrupted chest compressions to maintain myocardial and cerebral perfusion," Zoll said. "It offers the benefit of freeing up rescuers to focus on other life-saving interventions, and keeps them safer by eliminating the need to conduct CPR while unrestrained in the back of a moving ambulance."

More than 4,000 AutoPulse units have been deployed in hospitals and emergency services worldwide.

Zoll markets and sells its products in more than 140 countries.

$4.5 million round for Vivacta

Vivacta (Sittingbourne, UK) said that following successful development of its TSH test for thyroid function, together with prototype commercial readers, it has closed a $4.5 million financing round that was fully subscribed by existing investors, including AGF Private Equity, HBM Bioventures, Spark Ventures and Viking Technologies.

CEO Neil Butler said, "the success of this financing round underpins the support we have from our shareholders and signals their confidence that our ultrasensitive immunochemistry platform will reset the benchmark for diagnosis at the point of care.

He added, "The clinical evaluation of the system has now commenced and we anticipate achieving regulatory clearance within 12 months. The cartridge pilot manufacturing facility has commenced weekly manufacturing campaigns for internal evaluation. Validation of the facility and product is planned for later this year."

New Brussels office for CRO

Chiltern (London), a global clinical research organization, reported the opening of a new office in Brussels, Belgium, and has named Maurizio Passinisi as its new country manager for Belgium and the Netherlands.

Passanisi has more than 15 years of experience working in both pharmaceutical and clinical research areas.

"Belgium and the Netherlands have always been attractive locations to conduct clinical trials," he said. "The quality of the research is outstanding. Belgium and The Netherlands have many key opinion leaders involved in clinical research, lending additional weight to the data and keeping these countries at the forefront of modern research."

Lewis Cameron, EVP for Europe at Chiltern, said, "Chiltern is experiencing healthy growth despite the current economic climate. [It] is continuing its growth in Europe and will shortly announce further expansion in Eastern Europe."

Chiltern has conducted trials in more than 40 countries and employs 1,400 in 29 countries.