A Medical Device Daily

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 the CE mark, the first Evia devices were 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 Philippe Ritter, MD, of University Hospital (Bordeaux, France), 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 Löscher, 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 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.

Collaboration on brain tumor drugs

to-BBB (Leiden, the Netherlands), a brain drug-delivery company, and Dr. Olaf van Tellingen from the department of clinical chemistry of the Netherlands Cancer Institute at Antoni van Leeuwenhoek Hospital said they will collaborate on the development of a potential new therapy for brain tumors.

van Tellingen's research group has developed a series of advanced experimental models to address key topics in the development of new therapies for brain tumors, including their transport across the blood-brain barrier (BBB).

to-BBB's G-Technology is designed for safe brain delivery of different classes of drugs by formulating these drugs into proprietary glutathione coated stealth liposomes. The G-Technology has shown proof of concept in several disease models, based on which the research group of van Tellingen and to-BBB will join forces to develop brain-targeted liposomes with encapsulated anti-cancer drugs.

Pieter Gaillard, chief scientific officer of to-BBB, said, "We are looking forward to [combining] to-BBB's brain delivery technology with Dr. van Tellingen's capabilities in the area of brain tumors to be able to ultimately improve the lives of patients with this devastating disease."

Turkish CyberKnife sale

Accuray (Sunnyvale, California) reported today that the Turkish Ministry of Health has purchased two CyberKnife Robotic Radiosurgery Systems for installation in Ankara and Istanbul.

Turkey's first CyberKnife System was installed at Anadolu Medical Center in January 2005. A second system was installed in Turkey at Hacettepe University Hospital in May 2007.

In addition to the two recent purchases by the Ministry of Health, a fifth system for installation within Turkey was recently purchased by Istanbul University's Oncology Institute. The sales of these systems were coordinated by local distributor Radontek Ltd.

"The Turkish Ministry of Health's purchase of two CyberKnife Systems is further validation of the system's worldwide clinical acceptance, particularly [among] government institutions," said Euan Thomson, Ph.D., president/CEO of Accuray.

The CyberKnife Robotic Radiosurgery System is the world's only robotic radiosurgery system designed to treat tumors anywhere in the body non-invasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in real time throughout the treatment.