St. Jude Medical (St. Paul, Minnesota) reported the FDA approval and market launch of its newest platform of pacemakers, the Victory family of devices. The product will be immediately available in the U.S. and Europe. The product family received the European CE mark last fall. Among the features included in Victory pacemakers are optimized settings designed to save time at implant, Ventricular Intrinsic Preference technology designed to minimize ventricular pacing, and the FastPath summary screen expected to speed follow-up exams.
“The Victory pacemaker significantly reduced device set-up time at implant because it is pre-programmed with optimized settings that contribute to the efficiency and success of the procedure,” said Raymond Schaerf, MD, chairman of the department of surgery and chief of thoracic surgery at Providence Saint Joseph Medical Center (Burbank, California), who performed the first U.S. implant of the Victory XL DR pacemaker.
The company said that physicians in Europe are already reporting the benefits of the device’s advanced technology that is designed to reduce in-clinic follow-up time without compromising patient care. “The ability of the Victory pacemaker to measure thresholds and intrinsic events and display those results with EGMs for quick verification means that 80% of standard follow-up testing is complete when the patient walks in the door,” said Johannes Sperzel, MD, who performed the first patient follow-up at Kerckhoff Klinik Kardiologie (Bad Nauheim, Germany).
Engineered to anticipate a wide variety of the diagnostic and therapy needs of patients, Victory pacemakers (models 5810 and 5816) also offer a suite of algorithms designed to make it easier for physicians to manage patients with AF. The Victory family also introduces the VIP technology, an enhancement developed from years of clinical experience with the company’s AutoIntrinsic Conduction Search feature. VIP technology is designed to promote more natural heart function and minimize ventricular pacing.
Elsewhere in the product pipeline:
• Analogic (Peabody, Massachusetts) reported that the FDA has given market clearance for the FetalGard Lite-NIBP (Non-Invasive Blood Pressure) fetal monitor. The FetalGard Lite-NIBP measures maternal non-invasive blood pressure for monitoring pregnancy-induced hypertension in addition to providing standard fetal monitoring capabilities. The device offers “beat-to-beat” fetal heart rate analysis on twins, and measures maternal uterine activity and blood pressure. It is portable, battery-operated, and weighs five pounds, making it appropriate for use in a variety of settings. The company said the FetalGard Lite-NIBP also offers the first alternative to Z-fold paper because it can store and transfer tracings to a PC for viewing, reporting and printing. Alternatively, multiple patients’ records can be stored and subsequently “fast printed” to an Analogic Z-fold recorder when hard copies are needed for review or patient records.
• CryoCath Technologies (Montreal, Quebec) reported that Dr. Douglas Packer from the Mayo Clinic (Rochester, Minnesota) presented additional data from the feasibility stage of the Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF) investigational device exemption study using the company’s Arctic Front catheter to treat atrial fibrillation (AF). The data were presented at the International Boston Atrial Fibrillation Symposium. Packer reported data on two sets of Arctic Front patient data. He reviewed the 12-month data from the original 20-patient European trial which saw 84% of patients AF-free (a further 10% had significant reductions in AF burden and have conditions that do not warrant re-treatment and are considered clinically successful). Secondly, he reported on early data from 15 patients treated in the feasibility stage of the STOP AF trial who have now reached a minimum three-month follow up point. Thirteen patients are now AF-free (87%), one has been retreated, and one other scheduled to be retreated (one retreatment is consistent with the study’s protocol). There were no reported permanent serious device-related adverse events.
• Despite what it considered as signals that its premarket application for use of its cryoablation system to treat atrial flutter was sailing along unhindered toward FDA approval, CryoCor (San Diego) last month reported receiving a “not approvable” letter from the agency. “We were not expecting this decision,” said CEO Greg Ayers in a conference call. Ayers said that the FDA’s letter indicated that it had made an interpretation, different from the company’s, concerning “the patient data and categorization of patients to be included and excluded in the analysis of chronic efficacy,” the criteria it used in its trial supporting the application. He said the company had already talked to the reviewer of the PMA and the chief of the electrophysiology monitoring branch of the FDA “to obtain additional information regarding comments contained in the letter” in order to determine its next steps. Ayers said that the primary reason for the “not approvable” decision was based on the “subjective” method required for interpreting chronic efficacy. “The process requires complex interpretation of clinical data and can result in different interpretations as to the results,” Ayers said.
• Medwave (Danvers, Massachusetts), a provider of sensor-based, non-invasive blood pressure measuring solutions, reported that it has received FDA marketing clearance to sell its Primo hand-held spot blood pressure monitoring device. With accuracy the company said is comparable to an invasive arterial catheter, Primo is placed on the wrist. The user presses a start key, and within about 12 seconds, blood pressure and pulse rate values are displayed. Compact and lightweight, Primo is comfortable for the patient, easy to use and requires no calibration or routine maintenance, Medwave said.
• Merit Medical Systems (South Jordan, Utah), a manufacturer of disposable accessories used primarily in cardiology and radiology procedures, has introduced a new catheter securement device called the Revolution. The Merit Revolution adheres to a pati-ent’s skin and then is rotated to deploy suture material that secures catheters in place. It positions catheters for up to seven days, prevents kinking and allows maximum drainage flow by means of a raised support.
• Philips Medical Systems (Andover, Massachusetts) reported its new line of obstetrical care fetal and maternal monitors, Avalon FM20 antepartum and Avalon FM30 intrapartum. Built on Philips’ IntelliVue patient monitoring platform, the Avalon fetal monitors feature enhanced functionality and documentation capabilities in a compact, ergonomic, and easy-to-use product. Both monitors can be used to monitor multiple births, with advanced features that include high-quality ultrasound tracing and cross channel verification. The Avalon FM20 and FM30 monitors integrate monitoring of maternal blood pressure and pulse rate with measurement of multiple fetal heart rates and uterine activity. The Avalon FM30 covers patients from the onset of contractions through the final stages of delivery with its full set of external and internal fetal parameters and maternal monitoring capabilities. Data from the monitors can be automatically transmitted to the Philips OB TraceVue obstetrical information system for comprehensive information management across the obstetrical care continuum. Philips also reported the availability of its new fetal monitoring starter kits – packages of companion supplies for the Avalon FM20 and Avalon FM30.
• Spectranetics (Colorado Springs, Colorado) said that the LACI (Laser Angioplasty for Critical Limb Ischemia) clinical trial results were published in the current issue of the Journal of Endovascular Therapy. The objective of the LACI trial was to evaluate the effectiveness of excimer laser angioplasty in critical limb ischemia patients with complex blockages in their legs. The study population included only those patients who were determined to be poor or non-surgical candidates. As a result, these patients were at high risk for limb loss. The primary endpoint of the trial, limb salvage among surviving patients at six months following the initial laser treatment, was 93%.
• Sutura (Fountain Valley, California) said it has received 510(k) clearance from the FDA for use of the preloaded guidewire version of its SuperStitch vascular suturing device. The guidewire version of the device allows physicians to re-access a vessel during procedures by placing the sutures first and completing suturing of the vessel after performing additional procedures if they choose. The guidewire version also enables physicians to use the SuperStitch GW on patients where they feel that maintaining access is more crucial. Sutura’s line of SuperStitch devices provide sutured closure of the arteriotomy site utilizing the existing catheter sheath introducer or cannula during fluoroscopically guided procedures and directly through the open arteriotomy during open surgical procedures.