A Diagnostics & Imaging Week
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.
Biotronik Evia pacemaker implants in Europe
Biotronik (Berlin), a pioneering firm in wireless remote monitoring technologies and a major manufacturer of implantable cardiac devices, reported CE-mark approval and first implantations of its new Evia cardiac pacemaker series, offering superior therapies and functionality in every step of advanced patient management.
After receiving CE mark, the first Evia devices were successfully implanted simultaneously at seven hospitals across Europe during the first week of June. "Unique features such as Closed Loop Stimulation and Home Monitoring, combined with new functions make Evia the most complete pacemaker available. I can now offer my patients a new level of therapy, and I have a streamlined patient management procedure from implantation to long-term monitoring, this bodes well for the future of bradycardia therapy," said Dr. Philippe Ritter, MD, of University Hospital (Bordeaux, France) and Chairman of Cardiostim, after the first implantation in Bordeaux on June 4.
Other initial implant sites and the surgeons involved included Johan Brandt, MD, Lund University Hospital (Lund, Sweden); Steffen L scher, MD, Klinikum St. Georg (Leipzig, Germany); Thomas Melchior, MD, Roskilde Sygehus (Roskilde, Denmark); Michael N rnberg, MD, Wilhelminenspital Wien (Vienna, Austria); Philippe Ritter, MD, Centre Hospitalier Universitaire de Bordeaux (Bordeaux, France); Martin Schalij, MD, University Medical Center Leiden (Leiden, the Netherlands); and Jorge Silvestre, MD, Hospital Universitario La Paz (Madrid, Spain).
Combined with the Biotronik Home Monitoring, Evia is the world's first and only pacemaker series which wirelessly transmits all required patient and device data, including IEGM Online HD, to perform a complete remote follow-up. "This technology is fully compliant with HRS/EHRA device follow-up specifications, and in line with this, the FDA recently approved Biotronik Home Monitoring as the only remote monitoring system on the market that can replace conventional device interrogation during follow-ups," Biotronik said.
It noted that Biotronik Home Monitoring "allows physicians to remotely monitor their Evia patients' clinical and device status from anywhere in the world. This technology has been proven to be reliable and safe, and has demonstrated the highest patient compliance in the industry, as minimal patient involvement is required to operate the system and the data transmission is fully automatic."
The company said the early detection function of Biotronik Home Monitoring "allows clinicians to access their patients' clinically relevant event data more quickly so they can make immediate therapy decisions. In this way, for example, atrial fibrillation events, which can be asymptomatic, are detected earlier. Additionally, the new intelligent 'traffic light' system allows for automatic patient classification aimed at significantly simplifying clinic workflow."
Biotronik said new functions that simplify complex programming and enable easier and faster follow-ups "become increasingly important. Offering a complete solution for advanced patient management, Evia provides physicians with the most physiological therapy available, as well as enhanced functions for fast and efficient implantations, accelerated follow-ups and reliable long-term monitoring of patients."
It said the Evia system now permits physicians to streamline the initial device set-up process and access all necessary data required during follow-up without spending valuable time on interrogating the device.
Evia pacemakers are already designed to be MRI-conditional, and Biotronik said it is planning to launch a new pacemaker-lead system which will be MRI-compatible under specific conditions during the first half of 2010.
Lantheus in Australian supply agreement
Lantheus Medical Imaging (North Billerica, Massachusetts) said it has finalized an arrangement with the Australian Nuclear Science and Technology Organization (ANSTO; Lucas Heights, Australia) to receive molybdenum-99 (Mo-99) produced from low-enriched uranium (LEU) targets in ANSTO's new OPAL reactor.
This supply arrangement positions Lantheus to be the first company to supply technetium-99m (Tc-99m) derived from LEU to the U.S. market and demonstrates, the company said, its commitment to ensuring reliable supply and global access to Tc-99m, the medical isotope used in about 80%of all nuclear medicine procedures.
Lantheus will soon receive a supply of Mo-99 at regular intervals from ANSTO for use in its TechneLite generator line, which is currently distributed to the U.S. and Canadian markets.
ANSTO has secured the necessary regulatory approval from the Therapeutic Goods Administration (TGA) in Australia to use the LEU Mo-99 in a Tc-99m generator. The LEU-derived Mo-99 from ANSTO has been tested and validated by Lantheus for use in its TechneLite generator line to ensure its consistency and reliability.
Lantheus said this arrangement supports its supply chain diversification strategy and marks another step to address the limited and fragile global Mo-99 supply chain, as evidenced by the current NRU reactor shutdown in Canada.
ANSTO is working closely with nuclear safety and health regulators, both domestically and overseas, to expedite all necessary approvals to allow long-term production and export of medical isotopes.
Lantheus, together with ANSTO, is working closely with the FDA and Health Canada to achieve the necessary LEU Mo-99 approvals for the U.S. and Canadian markets.
"This supply arrangement marks a significant step in the advancement of medical imaging – for the first time in industry history, we will be able to offer the nuclear medicine community in North America a LEU-derived Mo-99 through our TechneLite generator line," said Lantheus President/CEO Don Kiepert. "We have been actively exploring new options for securing Mo-99 produced using LEU, and in ANSTO we have found an ideal partner with which to achieve that strategic goal. This arrangement will help ensure patients receive the benefits of diagnostic imaging with Tc-99m and at the same time support U.S. non-proliferation efforts to move from commercial use of HEU to LEU."
CE mark for Cepheid Xpert test
Cepheid (Sunnyvale, California) reported the release of its improved Xpert BCR-ABL Monitor test to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. With improved time to results, the test now detects the BCR-ABL chromosomal translocation in about 2 hours as compared to 2.5 hours for the original product release.
The test is intended to aid European clinicians in the monitoring of patients with chronic myelogenous leukemia (CML). The test runs on Cepheid's GeneXpert System, which it terms "the world's leading on-demand molecular diagnostic platform."
"The GeneXpert System is capable of producing unheard of sensitivity levels for a molecular system - a potential key benefit in monitoring minimal residual disease," said CEO John Bishop. "Similar to our recently announced test for Mycobacterium tuberculosis, Xpert BCR-ABL Monitor uses nested PCR, a critical amplification process possible only within a fully closed integrated molecular sample prep/test system. We will continue to extend the many unique benefits of the GeneXpert System across multiple markets and testing applications."
Worldwide, CML affects one to two people per 100,000 annually. The Europe Against Cancer Program practice guidelines, for management of patients with CML, call for use of quantitative reverse transcription polymerase chain reaction (RT-PCR) assays during the initial workup of patients with chronic phase CML, and in monitoring for minimal residual disease. Patients may have their blood tested as often as four times a year.
"Cepheid's . . . test is a powerful tool for monitoring patients being treated for chronic myelogenous leukemia," said Ellie Nacheva, MD, PhD, head of lab-leukemia cytogenetics at the Royal Free and University College School of Medicine (London). "The . . . sensitivity of the GeneXpert System enables clinicians to process molecular tests in their own facilities instead of sending patient samples to a central lab and waiting for results."
Siemens installs S2000 systems
Siemens Healthcare (Erlangen, Germany) reported the installation of three Acuson S2000 ultrasound systems at Bradford Royal Infirmary (Bradford, UK).
One S2000 has been installed into the radiology department for use in general radiology, musculoskeletal and paediatric work. The remaining two systems are being used in the maternity department's fetal abnormality clinic for scanning fetal hearts and abnormalities, nuchal translucency (NT) scans on twins, and for improved visualization of the female pelvis in transvaginal (TV) scans.
The S2000 ultrasound systems were ordered as a result of the updated antenatal guidelines published last year by the UK's National Institute for Health and Clinical Excellence and were selected due to the excellent quality image resolution and highly ergonomic use.
"Our department deals with a lot of high-risk pregnancies, so being able to achieve high quality fetal scans is an important service that we can now confidently offer," said Virginia Lodge, principal superintendent for ultrasound at Bradford Royal Infirmary. "The color Doppler imaging is superb, providing us with clear, detailed images of any abnormalities so that the next diagnostic steps can quickly be taken."
Bernadette Leonard, regional sales manager for ultrasound products at Siemens Healthcare, said, "The S2000 ultrasound systems will significantly enhance the in-house service available to patients at Bradford Royal Infirmary, providing a clear insight during fetal scans and gynecology examinations. This will enable the early detection and identification of any risks or abnormalities during pregnancy, allowing patients to receive the required level of care and attention."