A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) has received a CE mark for its Accent MRI pacemaker and Tendril MRI lead. The system, designed and tested for safe use in a MRI environment and approved as MR-Conditional, allows patients to undergo full-body, high-resolution MRI scans. According to St. Jude, the new Accent MRI pacemaker system is an advanced pacing platform that provides wireless telemtry and algorithms to address individual patient conditions, with the added benefit of MRI scanning capability.

“The Accent MRI pacemaker system meets important clinical needs without compromise by offering superior pacing technology in addition to full MRI-compatible scanning capabilities with no anatomical zone or MRI power restrictions,“ said Eric Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division.

Each year, about one million pacemakers are implanted worldwide, and up to 75% of pacemaker patients could benefit from MRI scans during the lifetime of their devices, St. Jude noted.

“Many of my patients have faced severe health problems, such as cancer, stroke and neurological disorders, for which MRI is fast becoming the preferred diagnostic tool,“ said Burkert Pieske, MD, chief of cardiology at University Hospital Graz (Graz, Austria). “Until recently, many of my pacemaker patients were contraindicated for an MRI, but the new Accent MRI system allows my patients a full-featured pacemaker with access to full-body scanning to address their additional health concerns.“

In the U.S., Medtronic (Minneapolis) took the honors earlier this year of becoming the first company with an FDA-approved pacemaker specifically designed for the MRI environment when it won approval of its Revo MRI SureScan system (Medical Device Daily, Feb. 11, 2011).

St. Jude says its MRI pacemaker system features an MRI Activator device that provides a simple alternative option for programming the device to the appropriate MRI mode for use during the scan. Since it does not require a programmer, this increases both clinical and personnel efficiency. A single button press on the handheld MRI Activator device can be used to program the specific device parameters to be used during the MRI scan. These parameters are pre-selected by the patient's physician and stored in the Accent MRI pacemaker, St. Jude noted. The MRI Activator can then be used to program the device back to its original settings after the scan has been completed.

“The Accent MRI pacemaker system offers MRI capabilities without any trade-offs,“ said Karlheinz Tscheliessnigg, MD, chief of cardiac surgery at University Hospital Graz. “The device is not only an advanced pacemaker that allows for efficient patient management, but it also features the Tendril MRI lead that gives me the flexibility to easily maneuver the lead into position because of its excellent handling characteristics.“

The Tendril MRI pacing lead offers unique design advantages for safe, MR-Conditional scanning. The thin diameter makes it easier for physicians to implant, as it retains the handling characteristics of the well established Tendril platform of pacing leads. In addition, the lead features Optim lead insulation, the first silicone-polyurethane co-polymer material created specifically for cardiac lead use. The Optim insulation is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation.

In addition, the Accent MRI pacemaker system features InvisiLink telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician. Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the office or through remote monitoring via the Merlin.net Patient Care Network (PCN), a secure, Internet-based remote care system. The Merlin.net PCN gathers and stores data from the implant procedure, in-clinic follow-up visits and remote transmissions sent from a patients home, allowing for more efficient and convenient care and device management, including the ability to perform a full interrogation of the pacemaker at home after the patient completes their MRI study.

The Accent MRI pacemaker has several features that simplify patient management. These features include AutoCapture Pacing System technology that measures the heart's reaction to pacing beat-by-beat, and the VIP algorithm that enables the heart's intrinsic rhythm to prevail when appropriate, thereby reducing unnecessary ventricular pacing.

ETView inks distribution agreement with Stopler

ETView Medical (Tel Aviv, Israel), a commercial stage device company traded on the Tel Aviv stock exchange, said it has entered into a distribution agreement with Stopler Belgium. The agreement enables Stopler to market ETView's lead product, TVT, for a period of three years in Belgium. ETView's TVT combines high-flow ventilation airway management with continuous video monitoring to overcome current limitations and associated adverse surgical events during lung isolation surgeries. Other terms were not disclosed.

Stopler Belgium is a division of the SIMED Group (Stopler International Medical), a European-based diversified healthcare provider, with a wide range of activities including distribution of medical equipment in Holland and Belgium.

“The TVT product family is currently being distributed across Europe and the United States,“ said Arie Ben-Josef, CEO of ETView Medical. “ETView will continue to provide best-in-class airway management solutions for sophisticated thoracic surgical procedures through TVT and additional technologies under development.“

Russian MOH finances SuperSonic ultrasound

Under a public program from the Russian Ministry of Health (MOH), twenty-six hospitals throughout the Russian Federation acquired SuperSonic Imagine's (Aix-en-Provence, France) Aixplorer MultiWave ultrasound system. The Aixplorer, with MultiWave technology, is considered the most technologically advanced system available on the market, according to SuperSonic.

This public program titled:“Viral Hepatitis“ is part of a national project, financed by the Russian MOH and started in 2007, named “Prevention and Struggle with Socially Significant Diseases.“

Heinemann Medizintechnik (Moscow), the exclusive distribution partner for SuperSonic Imagine for the Russian Federation, was awarded this pubic tender for the Aixplorer systems at the end of 2010.

Twenty-six hospitals across the Federation from Sakhalin to Murmansk city were equipped with the Aixplorer because of its exceptional B-mode image quality and its unique technology, ShearWave Elastography, where tissue stiffness can be measured in kilopascals in a user-skill independent and reproducible manner. Tissue stiffness is an additional parameter that characterizes tissue and can be a valuable indicator of pathology. The Aixplorer, which has a worldwide installed base, brings clinicians significantly enhanced diagnostic information.