Heart valve kingpin Edwards Lifesciences (Irvine, California) reported the European and U.S. launch of a new mitral valve repair therapy specifically designed to treat the leaky mitral valve of patients suffering from congestive heart failure (CHF). The Edwards GeoForm annuloplasty ring, which features a 3-D shape, has been shown to successfully treat mitral valve regurgitation caused by cardiomyopathy, a common form of CHF that affects tens of thousands of people annually, and improve the function of the left ventricle, according to a presentation delivered at the annual meeting of the European Association for Cardio-thoracic Surgery (Windsor, UK) in Barcelona, Spain.

Steven Bolling, MD, professor of surgery and director of the University of Michigan Health System’s (Ann Arbor) Mitral Valve Clinic, presented results from a prospective study of 16 congestive heart failure patients, all of whom were suffering from mitral valve regurgitation due to distortion of their heart’s left ventricle. Six months after the patients’ mitral valves were surgically repaired with the GeoForm annuloplasty ring, their mitral valve regurgitation was eliminated and the left ventricle was re-formed. Edwards developed the GeoForm ring in conjunction with Ottavio Alfieri, MD, of St. Raffaele Hospital (Milan, Italy) and Bolling.

“While still early, these results clearly demonstrate excellent outcomes for patients suffering from severe mitral valve regurgitation and left ventricular dysfunction,” said Bolling. “We believe this heart valve repair ring will help break the cycle of mitral valve regurgitation and left ventricular distortion that can be caused by certain forms of congestive heart failure.”

Elsewhere in the product pipeline:

• AMI Semiconductor (Pocatello, Idaho), a manufacturer of integrated mixed-signal and structured digital products, reported the availability of a reference design and support materials for a complete DSP-based electronic stethoscope. Targeted at original equipment manufacturers, the electronic stethoscope reference design allows for improved accuracy in assessing and classifying cardio-respiratory pathologies. The AMIS e-stethoscope reference design supports the bell, diaphragm and extended operating modes of first-generation electronic stethoscopes. Enabled by the company’s BelaSigna 250 DSP-based audio processing system, the e-stethoscope also allows for digital recording of cardiac and pulmonary sounds into non-volatile memory, an enhanced user-interface and minimal CPU usage along with the flexibility for OEMs to customize or develop their own signal processing algorithms. The company said enhanced features of the e-stethoscope reference design include amplification and equalization; recording and playback; selectable mode and convenient user interface; flexible design; ultra-low power DSP subsystem and wireless capability.

• ATS Medical (Minneapolis) has introduced the ATS Medical Thoracic Port System, which incorporates new technology designed to complement robotic surgery and bring what the company termed “significant improvement” to minimally invasive cardiac surgery procedures. Consisting of stainless steel ports in six sizes, the ATS Medical Thoracic Port System “facilitates excellent visibility in the chest without interrupting the surgical field,” ATS said. It said that “painful rib spreading” is eliminated and travel of fat and tissue into the chest cavity is minimized, lowering the risk of embolization. The components of the system are sterilizable and reusable, ATS said, reducing the cost and waste associated with single-use products. The company said it exhibited the Port System and the ATS Open Pivot Heart Valve at the joint meeting of the European Association for Cardio-Thoracic Surgery and the European Society of Thoracic Surgery, which ended in late September in Barcelona, Spain.

• A pediatric heart pump assist device made by Berlin Heart (Berlin, Germany) was has been implanted in a 3-month-old boy at Texas Children’s Heart Center (Houston), likely the smallest person in the U.S. to receive the device. The Berlin ventricular assist device was implanted in a five-hour procedure on Sept. 27, as a “bridge” to the time he can receive a heart transplant. Charles Fraser Jr., MD, chief of cardiovascular surgery at Texas Children’s, performed the surgery and said that the device gives Brady Burch “time to gain strength and more weight as he waits for a donor heart.” The baby, diagnosed with a failing heart at 26 weeks in utero, was not expected to live to term and so was delivered at 34 weeks. Doctors in Corpus Christi, Texas, said he had an enlarged left ventricle and severe aortic valve stenosis. At six weeks, he was transferred to the cardiovascular intensive care unit at Texas Children’s. Doctors then received approval from the FDA for emergency compassionate use of the Berlin Heart.

• Biosite (San Diego) said the FDA has cleared a new indication for its Triage BNP Test. The test can now be used to help physicians assess the risk of mortality or rehospitalization in heart failure patients. Previously, the test was cleared as an aid in the diagnosis of congestive heart failure, assessment of disease severity and risk stratification of patients with acute coronary syndromes. A review of studies investigating B-type natriuretic peptide (BNP) for prognostic utility in patients with heart failure concluded that every 100 pg/mL increase in BNP concentration was associated with a 35% increase in the relative risk of death, and that admitted heart failure patients whose BNP values did not decrease over the course of their treatment are at a particularly high risk of death or a cardiovascular event. The authors also found that higher BNP concentrations in asymptomatic patients were prognostic for future death or cardiovascular events.

• Cardiac Science (Bothell, Washington) reported that it is shipping a web version of its popular Pyramis cardiology data management system used by hospitals. The system allows storage, editing, retrieval and sharing of data from electrocardiographs, cardiac stress tests, Holter tests and 12-lead ECGs from bedside monitors. The companys said that with the new version installed, authorized users are able to access the data from anywhere. In November 2004, Cardiac Science – at the time Quinton Cardiology Systems – red a global value-added reseller agreement with the Cerner (Kansas City, Missouri) under which Cerner distributes the Pyramis system. As part of the agreement, Cerner will develop an interface to Pyramis with its hospital information system architecture, Cerner Millennium, which Cardiac Science said will expand the ability of both companies to provide advanced, integrated solutions for managing cardiology data for hospitals and physicians’ offices.

• Cardiome Pharma (Vancouver, British Columbia) said results of its 276-patient Phase III study (ACT 3) in atrial arrhythmia achieved its primary endpoint, showing that of the 170 patients with recent-onset atrial fibrillation, 52% of those receiving an intravenous dose of RSD1235 converted to normal heart rhythm, compared to 4% of placebo patients. Data also showed that the recent-onset patients who converted to normal heart rhythm within 90 minutes had a median time to conversion of about eight minutes from the initiation of dosing. The company said the results are consistent with those reported following an earlier pivotal Phase III study, Act 1, reported last December.

• Cardiovascular Systems (CSI; Minneapolis) said it has received conditional investigational device exemption (IDE) approval from the FDA to begin its clinical trial of its Orbital Atherectomy System for treatment of peripheral artery disease at two sites. The trial is eventually expected to enroll a total of 124 patients at up to 10 centers. Full approval is contingent upon agency approval of an IDE supplement that has been submitted following some informed consent changes requested by the FDA, and after 30-day follow-up of the first 10 patients. The Orbital Atherectomy Device uses a diamond-coated, rotating cutting surface to ablate tissue. The company said it is working on obtaining approval of an IDE for using the system to treat occluded coronary arteries and also is conducting a post-approval clinical trial in Europe to treat peripheral vascular disease, with plans for a European coronary trial in early 2006. The Orbital Atherectomy System is CE-marked for peripheral use in the European Union.

• Dade Behring (Deerfield, Illinois) said it has received FDA clearance for the use of its Stratus CS Acute Care D-dimer assay as an aid in the diagnosis of venous thromboembolism (VTE), also known as deep vein thrombosis or pulmonary embolism. The clearance included performance data with a defined cutoff value for this method on the Stratus CS System. The company said utilization of pretest probability assessment, together with the Stratus CS Acute Care D-dimer assay, aids in the diagnosis of VTE.

• Impulse Dynamics (USA) (Orangeburg, New York) said cardiologists at Beth Israel Medical Center (New York) are enrolling patients in the company-sponsored FIX-HF-5 (Fix Heart Failure 5) study, which is looking at the safety and efficacy of the Optimizer System in treating moderate-to-severe heart failure. The Optimizer pulse generator delivers electrical signals to the heart muscle in the midst of its pumping action, in effect “fooling” it into producing more intracellular calcium and thus increasing the heart’s ability to pump and contract. The Optimizer System consists of a programmable implantable pulse generator, a portable programmer and two right ventricular leads. It is based on a new technology known as Cardiac Contractility Modulation (CCM). The CCM signals are “non-excitatory,” meaning they are delivered during the absolute refractory period and therefore cannot initiate a new contraction. FIX-HF-5 is targeting to enroll about 400 New York Heart Association Class III or Class IV heart failure patients at up to 50 sites across the U.S.

• InterCure (Cambridge, UK), a manufacturer of products that harness the therapeutic power of breathing for the treatment of hypertension, heart failure, respiratory diseases and other conditions, said its new interactive breathing device RESPeRATE is now available in the UK. The company said a pooled analysis of seven separate clinical trials presented at the recent British Hypertension Society annual meeting demonstrated that high blood pressure was significantly decreased, with no observed side effects, using RESPeRATE. The abstract is published in the Journal of Human Hypertension, Volume 19, 2005.

• Merit Medical Systems (South Jordan, Utah), a manufacturer of disposable accessories used primarily in cardiology and radiology procedures, reported full market release of its BackStopPlus safety device. The BackStopPlus combines a closed waste disposal basin and temporary sharps holder in a single safety product, helping protect healthcare workers from exposure to blood-borne pathogens and needle-related injuries. It is being introduced along with the MiniStopPlus, another safety product.

• MIV Therapeutics (MIVT; Vancouver, British Columbia), a developer of next-generation biocompatible passive and drug-eluting stent coatings and drug delivery technologies for the treatment of cardiovascular disease, reported that its intellectual property portfolio has achieved a total of 43 U.S. and international patents and patent applications. The company said the steps taken to secure patent protection for its IP portfolio reflect MIVT’s strategy to generate significant revenues from its proprietary coating solutions, targeting the projected $100 billion dollar global marketplace for coronary stents and advanced drug-delivery systems.

• St. Jude Medical (St. Paul, Minnesota) demonstrated a range of cardiac surgery products – including new valve replacement and repair products and advanced beating-heart cardiac tissue ablation technology – at September’s European Association of Cardio-thoracic Surgeons (EACTS) meeting, in Barcelona, Spain. The company began the European launch of its Epicor Cardiac Ablation System at EACTS. This system features a high-intensity focused ultrasound (HIFU) energy source, which enables physicians to create continuous transmural ablative lesions safely and reproducibly, without the need to put patients on a heart-lung bypass machine. Results of a prospective multi-center study using the Epicor Cardiac Ablation System were published in the September issue of the Journal of Thoracic and Cardiovascular Surgery. The study showed that at six-month follow-up, 85% of patients in the study group remained free from atrial fibrillation. The St. Jude Medical Rigid Saddle Annuloplasty Ring also was introduced at EACTS. The device is the only annuloplasty ring designed to approximate the mitral valve’s natural, 3-D saddle shape, resulting in less stress on the valve’s leaflets and chords.

• Vascular Solutions (Minneapolis) said it has received 510(k) clearance from the FDA for the launch of its next-generation V3 version of the Pronto extraction catheter. The Pronto extraction catheter is clinically used for the percutaneous removal of soft thrombus from vessels in the arterial system. The new V3 version incorporates a fully braided construction, hydrophilic coating and a consistently large extraction lumen, all advances from the original Pronto catheter that was launched in the U.S. in January 2004. The Pronto consists of an extraction catheter with a proprietary atraumatic distal tip and large extraction lumen that can be percutaneously inserted into arteries to remove soft thrombus. The Pronto extraction catheter was initially developed by Dr. Pedro Silva of Milan, Italy, who exclusively licensed the design to Vascular Solutions.

• VNUS Medical Technologies (San Jose, California) said that five-year follow-up results on the VNUS Closure procedure have been published in the September issue of the Journal of Vascular Surgery. The VNUS Closure procedure is an endovenous radiofrequency treatment of venous reflux that uses a small catheter to close diseased veins in the legs, allowing blood to reroute to other healthy veins. Venous reflux disease often is an underlying cause varicose veins. The journal article, authored by Robert Merchant, MD, Olivier Pichot, MD, et al., reported results from a large multi-center international registry indicating that the VNUS Closure procedure exhibits long-term enduring efficacy and persistent patient symptom relief. Of 1,222 limbs treated, 87% of veins evaluated at five-year follow-up remained closed. Prior to treatment, 85% of patients experienced limb pain, whereas just 10% experienced pain six months after treatment and 8.5% at five years, according to the report. The company said the report also demonstrated that the VNUS Closure procedure has been used in small saphenous and accessory saphenous veins, in addition to great saphenous vein treatment. The VNUS Closure System has treated more than 100,000 patients since 1999.