A Medical Device Daily

Biotronik (Berlin), a manufacturer of implantable cardiac devices (ICDs) and wireless remote monitoring technologies, reported the first implantations of the Lumax DX system, a new single-chamber ICD concept.

According to the company, the first Lumax DX systems were implanted simultaneously at six hospitals across Europe during the third week of March. The system is designed to provide patients at risk of sudden cardiac death with a single-chamber ICD system that provides protection and reduces risk.

The Lumax 540 VR-T DX single-chamber ICD and the specially designed Linoxsmart S DX right ventricular lead with floating atrial dipole provide physicians with complete diagnostic information not only from the right ventricle, as in regular single-chamber ICDs, but also from the right atrium, including high resolution online IEGMs, Biotronik said.

The additional atrial information can be used for advanced discrimination of supraventricular tachycardias (SVTs) to avoid inappropriate ICD shock therapies and for diagnostic purposes for early detection of atrial arrhythmias, including atrial fibrillation (AF), to reduce the risk of stroke.

"The immediate information about atrial arrhythmias, even when asymptomatic, allows me to detect and treat AF early and minimize associated risks such as inappropriate therapies and stroke. Also, I can monitor the success of my AF therapies remotely with Biotronik Home Monitoring and contact the patient whenever needed," said Alexander Schirdewan, MD, from the Charité Campus Benjamin Franklin (Berlin), coordinating clinical investigator of the Linoxsmart S DX master study.

Lumax 540 VR-T DX uses the advanced Biotronik Smart Detection algorithm that analyzes the ventricular as well as the atrial heart rate to appropriately discriminate supraventricular tachycardias from ventricular tachycardias and thereby reduce the number of inappropriate therapies and ensure that a shock is only delivered when absolutely required, according to the company.

"So far, single-chamber ICDs were limited to ventricular information for the discrimination of SVTs.

The Smart algorithm also uses the additional information from the atrium and has proven reliable sensitivity and high specificity in dual-chamber ICDs, and now I can offer this technology to my single-chamber ICD patients too," said Antonio Curnis, MD, from Spedali Civili (Brescia), at the University of Brescia in Italy. Curnis was the principal investigator of the Italian ADAMO registry that already proved the high sensitivity and specificity of the Smart algorithm in a similar Biotronik ICD system, the company noted.

Combined with the Biotronik Home Monitoring, Lumax 540 VR-T DX is the world's first single-chamber ICD that wirelessly transmits all required patient and device data, including IEGM Online HD for early detection of ventricular and atrial rate disorders and to perform complete remote follow-ups, according to Biotronik.

"This innovative system completes our Lumax 540 series of premium ICDs, addressing unmet clinical needs in the treatment of AF," said Marlou Janssen, VP of global marketing and sales, Cardiac Rhythm Management at Biotronik. "It also helps to avoid inappropriate ICD therapies by providing unique patient protection with a single-chamber ICD."

Telemis inks OEM agreement with Maidis

Telemis (Belgium), a medical imaging company, said it has signed an agreement with Maidis (Paris), an international hospital information system (HIS) vendor in France and in the United Arab Emirates (UAE). The first project to be completed under the terms of the agreement is an integrated global HIS for the Oasis Hospital (Al Ain, UAE).

According to Telemis, the OEM agreement with Maidis signals the start of a new phase in the development of the Telemis group worldwide. By entering into OEM agreements with key healthcare vendors, the company aims to give more hospitals, clinics and radiology practices access to advanced PACS technologies that reduce costs and increase care quality by eliminating the need for X-ray film.

"This partnership demonstrates that Telemis can address the international needs of healthcare vendors by providing them with an innovative, flexible and easily integrated technology", said Stephane Ketelaer, CEO of the Telemis group.

As a result of the agreement, Telemis technology is an integral part of a Maidis solution that recently went live in the Oasis Hospital, the company noted. This fully integrated HIS solution integrating PACS technology allows Maidis users to view, diagnose, share, and comment on all types of medical images and diagnostic results produced in the hospital and stored on a server network. Additionally, the integrated solution offers different alternatives to distribute the images, such as CD/DVD burning, paper printing and web image distribution.

"Integration of the Telemis technology is key to delivering the advanced HIS/PACS solution for the Oasis Hospital," said Wagdy Zahran, CEO of Maidis International. "The partnership with Telemis paves the way for a long term business relationship."