A Medical Device Daily

The Sorin Group (Milan, Italy) reported CE-marking and first implants of its next-generation Reply pacemakers, calling them “the world’s smallest dual-chamber devices” at 8 cc.

The new line is designed to deliver automatic, physiologic pacing adapted to patients who have bradyarrhythmia.

The Reply pacemakers integrate Sorin’s SafeR pacing mode that constantly monitors a patient’s natural cardiac activity and reduces the amount of pacing delivered to the right ventricle, thereby promoting natural cardiac function.

The company said unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation, potentially fatal conditions and a heavy cost burden on healthcare systems.

While conventional pacemakers deliver unnecessary ventricular pacing in patients without heart block 50% to 80% of the time, Sorin says that SafeR reduces pacing in the ventricle to less than 0.1% in these patients.

The first Reply pacemaker implants were performed by Georg Noelker, MD, at Klinikum Coburg (Coburg, Germany), and Ezio Aim , MD, at the IRCCS Policlinico (Milan, Italy). Other implants were performed by Guy Pioger at the Alleray Clinic (Paris) and Christine Alonso, MD, at the Bizet Clinic (Paris).

Brachman said, “I’ve been using the first generation of SafeR since its introduction in 2003. This exclusive pacing technology has brought tremendous benefits to my patients who are now given chances to rely on their heart’s natural conduction when it is intact. I really appreciate SafeR because it provides optimal pacing therapy to my patients.”

The SafeR technology builds on Sorin’s AAIsafeR mode, which the company calls the first pacing mode designed to limit unnecessary ventricular pacing that was available in a pacemaker. AAIsafeR was launched in September 2003 in Europe and received FDA approval in May 2005.

Sorin says it was the first company to receive U.S. market clearance for a pacemaker incorporating a pacing mode that minimizes ventricular pacing.

In addition to SafeR, Sorin said the Reply pacemakers have advanced, automatic features that provide easier patient management by simplifying device checks.

CRO opens four European offices

Averion International (Southborough, Massachusetts), a clinical research organization (CRO), has strengthened its European operations by opening four offices.

The new Averion offices include Averion Europe, near Frankfurt, Germany, which will provide financial, administrative and operational support for Averion’s European operations; Averion Ltd., located in the UK, which will oversee operations for Averion’s clinical trials in northwestern Europe and coordinate activities with the company’s UK-based clients; Averion Clinical Research, in Austria, with responsibility for Central and Eastern European operations; and Averion Sp. z.o.o., in Poland, which will provide operational support and coordination of studies in Poland and the Baltic States.

“Expanding geographically is key to our growth strategy as it supports our ability to provide services to international clients and to capitalize on the rapid growth that characterizes the CRO industry,” said Philip Lavin, PhD, Averion CEO.

John Shillingford, PhD, president of Averion Europe, said, “We expect this expansion will open new opportunities for Averion as it allows us to gain access to large populations of patients in Central and Eastern Europe. We have already identified clinical sites within Europe with competent, well-trained staffs to run quality trials at competitive prices.”

Key personnel additions to Averion as part of opening the new offices include Ewa Chryanowska, MD, senior CRA/managing director of Averion Sp. z.o.o.; Jane Humphreys, regional director of Western European operations of Averion Ltd.; and Christian Tueni, MD, regional director Eastern European operations of Averion Clinical Research.

Averion International provides clinical research and regulatory compliance/validation services to the pharmaceutical, biotechnology and medical device/diagnostic industries. It has a therapeutic focus in oncology, dermatology, nephrology and medical devices.

First Hugs systems installed in Portugal

VeriChip (Delray Beach, Florida), a provider of radio frequency identification (RFID) systems for healthcare, said it has completed the installation of its first three Hugs infant protection systems in Portugal.

The installations represent the company’s first sales for the system in continental Europe. Overall, VeriChip reports having sold 15 Hugs infant protection systems in international markets.

The Hugs systems were installed in Hospital da Luz (Lisbon), Hospital Sao Joao de Deus-V.N. (Famalicao) and Hospital de Sao Teotonio-Viseu (Maia) by Safesis (Maia), the Iberian partner of Australian-based Austco Communication Systems, the primary international distributor for VeriChip in all markets outside the U.S.

The Hugs system is CE-marked.

“This is a significant step of our expansion into the continental European market, following the introduction of Hugs to the UK market,” said VeriChip President Daniel Gunther. “We are positioning ourselves for growth overseas. Working with international partners such as Austco, we will continue to pursue opportunities in the global market for infant protection systems as awareness of the infant abduction threat grows.”

Joao Lago, CEO of Safesis, said, “In light of two recent infant abductions in Portugal, we believe that the hospitals which received the Hugs systems in Portugal will benefit from the technology and security it offers parents.”

VeriChip is majority-owned by Applied Digital.

Accord signed on fluorescent reagents

AbD Serotec, a division of MorphoSys (Munich, Germany), and Thermo Fisher Scientific (Waltham, Massachusetts) have signed an agreement covering the use of Thermo Scientific’s DyLight Dyes in combination with AbD Serotec’s research antibodies to prepare a series of fluorescent reagents.

The resulting products will be available through the AbD Serotec sales catalog. Financial details of the accord were not disclosed.

“Fluorescent antibodies are particularly suited for detection of specific antigens in tissues or on cells and have become an indispensable tool for scientists worldwide,” said Dr. Achim Knappik, senior director of R&D at AbD Serotec.