The Sorin Group (Milan, Italy) recently reported CE-marking and first implants of its next-generation REPLY pacemakers, calling them “the world’s smallest dual-chamber devices (8 cc). This new line is designed to deliver automatic, physiologic pacing adapted to patients who have bradyarrhythmia, slow ventricular rhythms.
The first REPLY pacemaker implants were performed by Georg Noelker, MD, in the Internal Medicine of Klinikum Coburg (Coburg, Germany) and by Ezio Aim , MD, at the IRCCS Policlinico (Milan, Italy).
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 available in a pacemaker. AAIsafeR was launched in September 2003 in Europe, receiving 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.
The REPLY pacemakers integrate Sorin’s SafeR pacing mode that constantly monitors the patient’s natural cardiac activity and reduces the amount of pacing delivered to the right ventricle, thereby promoting natural cardiac function. It 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.
Sorin says that while conventional pacemakers deliver unnecessary ventricular pacing in patients without heart block 50%-80% of the time, it says SafeR reduces pacing in the ventricle to less than 0.1% in these patients.
Heart block is an electrical conduction disorder that results in the inability of the atria and ventricles, the heart’s chambers, to beat in a synchronized way.
In addition to SafeR, REPLY pacemakers employ advanced, automatic features that provide easier patient management by simplifying device checks.
Other implants were performed by Guy Pioger at the Alleray Clinic (Paris) and Christine Alonso, MD, at the Bizet Clinic (Paris). Sorin said it expects to introduce its new pacemaker platform to the European market in “the next few months,” followed by market relese in the U.S.
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Medtronic to beginEuropean trial ofMRI pacing
Medtronic (Minneapolis) last month reported the start of an international clinical study of the safety and efficacy of the EnRhythm MRI SureScan pacing system, calling it the first-ever pacemaker system to be developed and tested specifically for safe use in MRI machines under specified scanning conditions.
“MRI safety is an important issue,” said Torsten Sommer, chief of the cardiovascular section of the radiology department, University of Bonn (Bonn, Germany), and European lead radiology investigator for the clinical trial.
The pacing system consists of the dual-chamber SureScan pacemaker and CapSureFix MRI SureScan pacing leads. The first clinical trial devices were recently implanted in Europe.
All patients in the trial will receive an EnRhythm MRI SureScan pacing system, and approximately half of the participants will receive MRI scans, with the trial’s first MRI scans to occur two to three months after device implant. The study will compare the electrical and diagnostic system performance, as well as complication rates, among patients in both groups. Expected study duration is in about 24 months.
The EnRhythm MRI SureScan pacemaker includes modified hardware to minimize the level of energy transmitted through the lead/device connection point.
The pacemaker also includes a new SureScan feature that can be programmed “on” before an MRI scan to eliminate the impact of MRI-generated electrical noise, which can prevent necessary pacing therapy or cause the device to oversense and deliver unnecessary pacing therapy. When the SureScan feature is on, the device’s data collection and monitoring functions are temporarily suspended, while allowing the device to continue providing asynchronous pacing if needed.
Sommer said, “It is critical to protect patients from electromagnetic fields that could contribute to a loss of pacing therapy. The only sure way to do this is to study a pacing system that was designed specifically for use in MRI systems.”
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Ventracor reports progress in two U.S. trials of VentrAssist
Australian firm Ventracor (Sydney) reported progress in its U.S. clinical trial program and issued details of its U.S. clinical trial strategy for its VentrAssist product.
CEO Peter Crosby said Ventracor’s overall objective “is to reach the endpoint of U.S. FDA approval to market the VentrAssist in the U.S. as soon as possible. Working closely with the FDA on several initiatives, we have received approval for both the Bridge to Transplant Trial [BTT] and Destination Therapy [DT] Trial protocols.”
The DT protocol is a prospective, randomized, controlled trial with two modules, both with event-driven endpoints. Module A (primary) consists of 180 patients, with 2:1 randomization of the VentrAssist to the control arm, which does not require implantation of an LVAD approved by the FDA for DT. Module B (secondary) consists of up to 45 patients, with randomization of the VentrAssist to an LVAD approved by the FDA for DT.
The company said it believes that this trial has the potential to reduce time-to-market by up to 18 months compared to earlier DT trials. A patent on the trial design has been applied for.
The Bridge to Transplant (BTT) trial protocol is a single-arm prospective trial to an objective performance criterion of 75% 10% success, defined as heart transplantation or listed for heart transplantation at 180 days. There will be an interim analysis at 98 outcomes.
Ventracor said data from patients in the feasibility trial may be pooled with data in the pivotal trial, with both trials to commence following FDA approval after review of data from patients in the feasibility trial. The DT and BTT trials will be run concurrently.
Ventracor also recently reported being awarded an A$2.8 million Commercial Ready Grant from the Australian government to fund further development of its VentrAssist device.
Peter Crosby, CEO of Ventracor, said, “Continuous and rapid innovation helps grow market share in the medical device industry and this generous funding will help us maintain our culture of innovation.” He added, “Ventracor has the greatest worldwide experience of any third-generation centrifugal LVAD, with over 42 cumulative patients years of support in more than 80 implants and 13 implanting centers in Europe, Australia, New Zealand and the U.S.”
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Rcadia Medical’s CORanalyzer cleared by FDA
Rcadia Medical Imaging (Haifa, Israel), a developer of computer-aided diagnostic software, reported FDA clearance for its COR Analyzer I, used to assist in screening triage patients for coronary artery disease (CAD). The COR Analyzer I and COR Analyzer II software packages use image processing algorithms to analyze CT Angiography (CTA) studies to provide fast, accurate identification of CAD.
“Particularly in the ER . . . the Rcadia COR Analyzer software, which works hand-in-hand with CTA images, enables highly accurate identification of coronary artery disease as the cause for chest pain,” said Dr. Anna Chacko, vice chairman of the division of radiology at Boston Medical Center (Boston). Chacko added: “CTA is being rapidly adopted to triage patients in ERs across the U.S. Rcadia’s COR Analyzer II . . . streamlines patient care and prevents unnecessary delays in diagnosis and treatment.”
In a recent pilot study, Rcadia COR Analyzer I and COR Analyzer II packages successfully identified coronary artery disease in 100% of patients and 99% of the analyzed blood vessels.
“The real benefit of Rcadia’s software is its high negative predictive [NPV] value,” said Jeff Mendel, MD, chair of the Department of Radiology at Caritas St. Elizabeth’s Hospital (Boston). Mendel added that high NPV is the key to screening because it is so reliable in ruling out coronary artery disease.
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Gore gets AAA Excluder clearance inJapan
W.L. Gore & Associates (Flagstaff, Arizona) received regulatory clearance last month from Japan’s Pharmaceuticals and Medical Device Agency to market its Excluder AAA Endoprosthesis in that country.
The Gore Excluder is an implantable device indicated for the endovascular treatment of abdominal aortic aneurysm (AAA).
John Sininger, leader of the company’s Medical Products Division, said, “By expanding into this new market, Gore substantially increases the patient population able to benefit from less-invasive alternatives to traditional open-chest treatment of AAA.”
The Excluder is an endovascular graft/stent combination that seals off the aneurysm to create a new path for blood flow. Once the graft is positioned in the diseased aorta, the device self-expands using radial force, which in conjunction with metal anchors permanently secures it to the walls of the aorta.