A Medical Device Daily

ELA Medical(Bad Nauheim, Germany), a developer of cardiac rhythm management implantable and diagnostic systems, recently reported the first implant of its Ovatio DR, its new dual-chamber implantable cardioverter device (ICD) featuring the AAIsafeR 2 pacing mode. ELA said that the AAIsafeR 2 mode promotes the patient’s intrinsic conduction by limiting unnecessary pacing to the ventricle to 0.1% in patients who have normal heart conduction. The first Ovatio DR device was implanted earlier this month by cardiologist Johannes Sperzel, MD, department of Cardiology, at theKerckhoff-Klinik(Bad Nauheim, Germany) in a 51-year-old man with a history of myocardial infarction due to coronary artery disease. He suffers from episodes of polymorphic ventricular tachycardia and Sick Sinus Syndrome leading to symptomatic bradycardia. Sperzel said: ”Because Ovatio DR combines PARAD+, the most specific arrhythmia detection algorithm available today, with ELA’s AAIsafeR 2, the only pacing mode capable of managing all three types of heart blocks, the device has the potential to become the gold-standard therapy for the vast majority of ICD patients. Ovatio DR answers clinical needs for the physicians but also brings unprecedented benefits to the patient.” ELA said that recent studies have highlighted the importance of “not only maintaining normal AV synchrony, but also of avoiding unnecessary ventricular pacing. Excessively pacing the ventricle has been shown to be harmful to patients as it may increase the risk of mortality and hospital admissions due to heart failure.” And it cited a recent study indicating that, in some patients paced more than 50% of the time via an ICD, there is increased risk of new or worsened heart failure and ventricular tachyarrhythmia. AAIsafeR 2, ELA said, delivers ventricular pacing only when intrinsic cardiac impulses from the atrium are not conducted to the ventricle. “When intrinsic cardiac conduction resumes, AAIsafeR 2 automatically reverts back to physiological atrial-based pacing. AAIsafeR pacing technology has been available in Europe since September 2003 in ELA’s Symphony pacemakers.” It reported another implant of an Ovatio DR in the UK on June 10 by Dr. Vince Paul, consultant in Interventional Cardiology and Electrophysiology ofSt. Peter’s Hospital(Chertsey). He implanted a 50-year old man presenting with hypertrophic ardiomyopathy, incidence of non-sustained ventricular tachycardia and good atrio-ventricular conduction. Paul said: “With AIDA+ [Automatic Interpretation for Diagnosis Assistance], ELA’s powerful diagnostic tool, Ovatio DR offers me new insights into the management of my ICD patients. In addition, the intuitive and user-friendly display of important patient information makes Ovatio DR post-implant office visits easier and significantly reduces follow-up session times.” ELA said that the roll-out of the complete Ovatio ICD family is expected in the last quarter of 2005, together with its new generation of defibrillation leads. Gambro ‘confident’ U.S. spin will happen Gambro(Stockholm, Sweden) reported last week that it is pushing ahead with its plan to complete the sale ofGambro Healthcare US(Nashville, Tennessee) and to execute the share redemption program authorized at its annual general meeting. In December, Gambro unveiled its plan to divest its clinics in the U.S. toDaVita (Torrance, California) for a hefty $3.05 billion (SEK 20.5 billion) in cash (Medical Device Daily, Dec. 2, 2004). However, the transaction cannot be concluded until approved by the U.S. Federal Trade Commission. Gambro noted that DaVita recently has said that it expects one of the conditions of FTC approval will be the divestiture of a certain number of clinics. DaVita said that its discussions with the FTC are at “an advanced stage” and further steps have been taken in the process of the expected completion of divesting clinics. Final resolution of this process, Gambro said, may push sale closing beyond June 30, but that it “remains confident that the deal will close in the near term and the approved redemption program will be carried out.” S ren Mellstig, Gambro president and CEO, said, “The sale of the U.S. clinics is an important strategic step for Gambro. I am confident that the transaction will close – it is only a matter of time.” Abbott’s PCR HIV test CE-marked Abbott Laboratories(Abbott Park, Illinois) andCelera Diagnostics(Alameda, California), a joint venture betweenApplied Biosystems(Foster City, California) and theCelera Genomics GroupofApplera(also Foster City), reported that Abbott has received CE marking for a real-time polymerase chain reaction (PCR) test for monitoring HIV-1 viral load in patients. The Abbott RealTime HIV-1 assay was developed for use on the Abbott m2000 system, an automated instrument using real-time PCR technology for the detection and quantification of infectious agents. Abbott said that additional tests are in development for its m2000 system, including methods for detecting hepatitis C, hepatitis B, chlamydia and gonorrhea. Anna Maria Geretti, MD, PhD, head of the retrovirology laboratory atRoyal Free Hospital (London), said, “With the dramatic improvements in antiretroviral therapy for patients infected with HIV, the ability to accurately and quickly measure virus levels in the blood is essential in providing optimal treatment for patients and improving the quality of their lives.” Geretti’s laboratory was one of more than 20 clinical sites in Europe to participate in the evaluation of the RealTime HIV-1 assay and the m2000 system. “Our experience with this test has demonstrated its effectiveness in quantifying the diverse subtypes of this virus across a wide range of plasma RNA levels,” she said. Real-time PCR, a modification of standard PCR, is a system for “amplifying” DNA which can be detected in real time, rather than at the end of the process, hence ensuring more accurate and precise quantification. The reaction proceeds without the need for user intervention, providing increased productivity, reduced opportunity for human error, and more consistent, reproducible results. The m2000 instrument system purifies the nucleic acid from the specimen and automatically combines this with the assay reagents. The system’s software, described as user-friendly, provides results automatically calculated to provide highly reliable results for HIV viral load testing. Abbott calls the assay “among the most sensitive viral load tests available today, with a broad dynamic range, capable of detecting HIV-1 in plasma down to as few as 40 RNA molecules per milliliter and as high as 10 million RNA molecules per milliliter, thereby reducing the need for sample dilutions and additional testing.” Thomas White, PhD, chief scientific officer for Celera, said, “We’re particularly pleased with the robustness of this real-time test system and the accuracy and precision of the assay on the many subtypes of the virus.” He noted that previously rare forms of AIDS are becoming more frequent in developed countries. “By detecting these viral subtypes and also predicting whether they will be sensitive to various antiviral drugs, we are developing molecular diagnostics that help physicians determine the best possible course of treatment.” In 2002, Abbott and Celera entered into a long-term alliance to develop and market a range ofin vitromolecular diagnostics for disease detection and monitoring and therapy selection. Celera’s focus is on assay development and genetic marker discovery and validation. Abbott’s focus product development and marketing and it is the worldwide distributor for most products developed by the alliance.