Guidant (Indianapolis) said that the FDA has approved an expanded indication for the company's portfolio of cardiac resynchronization therapy defibrillators (CRT-D). The expanded indication makes Guidant's CRT-D devices available to thousands more heart failure patients, potentially helping them to live both better and longer, the company said. The expanded indication comes after the unanimous 8-0 vote in June by the Circulatory System Devices Panel of the FDA's Center for Devices and Radiological Health recommending the increased patient population.
The expanded indication, effective immediately, was based on results from the Guidant-sponsored Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial – results of which were published in the May 20 issue of The New England Journal of Medicine. Based on COMPANION's outcomes, the company claimed that its CRT-Ds demonstrated reduction in the risk of all-cause mortality or first all-cause hospitalization, reduction in risk of all-cause mortality, and reduction of heart failure symptoms. Data presented during the June panel meeting showed that of the more than 1,500 heart patients with defibrillators studied in COMPANION, use of the device cut their risk of death by 36%, compared to those who only took drugs to help manage their heart conditions.
Chris Hartman, director of heart failure marketing for Guidant's Cardiac Rhythm Management unit, explained the importance of the expanded indication to his company. "In essence, what this is doing at the highest levels is recognizing this therapy as kind of a stand-alone," he told Cardiovascular Device Update. "[Now], with a heart failure diagnosis alone, you can get this therapy, whereas before it was always kind of thought of as a combined therapy. So now it [CRT-D] truly is a heart failure device that has a heart failure indication."
With the expanded indication, Guidant has estimated that about 35,000 more people per year could be candidates for the implants under its proposal to the FDA. Multiply that by the average selling price of about $35,000 per unit, and you get an annual incremental $1 billion increase in market size.
Elsewhere in the product pipeline:
Advanced Stent Technologies (AST; Pleasanton, California), a developer of bifurcated stent technologies, reported receiving FDA conditional approval to incorporate its bare-metal Petal coronary bifurcation stent and delivery system into its ongoing U.S. BOSS clinical trial and has enrolled the first patient at the Lindner Clinical Trial Center (Cincinnati). AST said three other clinical centers would be added to use the Petal stent system. The conditional approval specifies enrollment of up to 30 non-randomized patients using the Petal system. AST said it is responding to FDA questions to gain full approval for enrollment of up to 100 Petal patients and anticipates adding another four to six centers "in the next several months." The company previously enrolled patients into the BOSS trial using its SLK-View stent system, which features a side branch aperture lacking ostial elements and is the predecessor to the Petal stent. The Petal stent system incorporates "petal" strut elements that deploy about 2 mm into the side branch vessel, supporting and covering the carina and side branch ostium in a circumferential manner, while also providing continuous unimpeded access to the side branch through the side aperture created by the deployment of the strut elements. AST said the Petal system is potentially applicable to up to 25% of all percutaneous coronary interventions.
Analogic (Peabody, Massachusetts) reported the formal market release of the Lifegard ICG Patient Monitor. The Lifegard ICG provides continuous cardiac output by measuring the ICG (impedance cardiogram) to calculate cardiac output. The monitor displays 12 additional direct and derived hemodynamic parameters plus non-invasive blood pressure and heart rate. It also displays both the electrocardiogram and ICG waveforms on a bright color display. The Lifegard ICG patient monitor includes a multi-function, color-coded, signal-quality indicator, a patient cable and electrodes. Weighing less than five pounds, the Lifegard ICG operates on battery power for up to two hours or on AC power. A built-in, strip-chart printer provides complete documentation.
AngioScore (Alameda, California) reported receiving the CE mark for its flagship AngioSculpt scoring balloon catheter. The company will begin shipment of the product to its distributors in Europe this month. The AngioSculpt scoring balloon catheter is a line of coronary angioplasty catheters comprising an angioplasty balloon surrounded by a system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands. The AngioSculpt is intended for the treatment of a hemodynamically significant coronary artery stenosis, for the purpose of improving myocardial perfusion.
Boston Scientific (Natick, Massachusetts) reported that enrollment has begun in its ATLAS clinical trial, the first trial using its new Liberte coronary stent as a platform for the company's paclitaxel-eluting coronary stent system. Taxus Liberte will be the next generation to its current paclitaxel-eluting coronary stent system, Taxus Express2. The Liberte stent, which has been designed to further enhance deliverability and conformability, particularly in challenging lesions, is currently available in international markets in a bare metal version. The pivotal study is designed to assess the safety and efficacy of a slow-release dose formulation paclitaxel-eluting Taxus Liberte stent system for the treatment of coronary artery disease. ATLAS, a global, multi-center trial, is scheduled to enroll 822 patients at 60 sites in the U.S., Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan. Boston Scientific also reported six-month clinical findings from the European component of its Milestone II Registry at the European Society of Cardiology congress. The company said it has enrolled nearly 3,700 patients worldwide in the registry, which has been designed to assess physician usage patterns and evaluate outcome data for the Taxus Express2 paclitaxel-eluting coronary stent system in "real world" patients. The Milestone II registry has enrolled 1,907 patients in Europe, where 118 centers were closely monitored. The results support the safety findings previously documented in the TAXUS clinical program "and provide further evidence that the Taxus Express2 stent system is widely utilized by physicians in treating difficult lesions and cases, especially in diabetic patients," the company said. The Milestone II database reports nearly one-third of its European patient population as diabetic, of which 11.5% are insulin-dependent. Insulin-dependent patients are considered at especially high risk for vascular disease and more likely to experience restenosis following angioplasty with bare metal stents. In the overall patient population of European data, Boston Scientific reports a 7.1% major adverse cardiac event rate (MACE) – cardiac death, myocardial infarction, need for repeat procedures) – a rate of 4.2% for repeat procedures and a 0.9% reported stent thrombosis rate (acute and late angiographically confirmed thrombotic events). Meanwhile, for the diabetic population overall the MACE rate was 8.9% and the need for repeat procedures was 5%. On a global basis, the registry has enrolled 3,689 patients, most of whom are finalizing their six-month follow-up data at this time. The registry is web-based and includes 164 centers in 32 countries. Twelve-month follow-up data is expected to be reported next year.
Cardica (Redwood City, California) reported clinical trial results from a multi-center study of its C-Port Distal Anastomosis System, technology used for creating a mechanical connection between two vessels during coronary artery bypass graft surgery. The trial, results of which were presented at the European Association for Cardiothoracic Surgery/European Society of Thoracic Surgeons joint meeting in Leipzig, Germany, evaluated the safety and efficacy of the C-Port device relative to historical results achieved with traditional suture-based anastomoses, usually considered the most challenging part of bypass surgery. The openness or patency of the vessels joined with the C-Port device at six months after the operation was reported to be 96.9%, which compares favorably to an average six-month patency rate for traditional hand-sewn anastomoses of 84.9%, as determined from historical published data.
CardioDynamics (San Diego), manufacturer of BioZ Impedance Cardiography (ICG) non-invasive cardiac monitoring systems, reported the results of its PREDICT (Prospective Evaluation and Identification of Decompensation by ICG Test) study, demonstrating a significant relationship between BioZ ICG parameters and the occurrence of a major heart failure outcome. The PREDICT study results were presented at the Heart Failure Society of America meeting in Toronto. The multi-center study followed 212 heart failure patients in outpatient clinics over a total of 2,316 visits. Each patient's BioZ ICG measurements were taken in addition to standard baseline variables and standard clinical variables. Principal Investigator Milton Packer, MD, director of the Center for Biostatistics and Clinical Science at the University of Texas Southwestern Medical Center (Dallas), said: "The PREDICT trial indicates that ICG variables may be able to identify patients at highest or lowest risk of a heart failure event during the 14 days following testing – and when included together with other clinical variables – may improve the short-term predictive power of the clinical assessments currently in routine use."
Dade Behring (Deerfield, Illinois) said a study in the Sept. 14 issue of Circulation concluded that information regarding platelet function obtained with its PFA-100 analyzer may help in the risk stratification of patients presenting with myocardial infarction (MI). The research study indicated that patients with ST-segment-elevation myocardial infarction (STEMI) show significantly enhanced platelet function when their platelets are subjected to shear conditions similar to those found in a stenosed coronary vessel by the PFA-100 platelet function analyzer. The study also examined whether platelet function, as measured by the PFA-100 analyzer, may predict the extent of myocardial damage. It was found that platelet function results at presentation were found to be independent predictors of the severity of myocardial damage as measured by CK-MB or troponin. The PFA-100 analyzer uses high-shear methodology to detect platelet dysfunction.
Edwards Lifesciences (Irvine, California) reported that the company has initiated a pivotal clinical trial of its next-generation Carpentier-Edwards BioPhysio aortic valve, which it said is the only replacement heart valve designed to mimic the physiologic motion of a natural heart valve. The world's first live implant of the new technology was simulcast in a presentation to attendees of the European Association of Cardiothoracic Surgery meeting. The surgery was performed at the Leipzig Heart Center (Leipzig, Germany), by Alain Carpentier, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou (Paris), and Friedrich Mohr, director of the department of cardiac surgery at the Leipzig Heart Center. "The intraoperative echocardiogram performed during this first live case indicated excellent hemodynamic performance, similar to parameters that would be expected in a healthy natural valve," said Mohr. The company said the enrollment period for the multicenter clinical trial is expected to last about 18 months, followed by an additional 12 to 18 months of post-procedural clinical monitoring and follow-up.
EP MedSystems (West Berlin, New Jersey) reported that it had received market clearance from the FDA for an enhancement to its EP-4 Computerized Cardiac Stimulator allowing the physician to stimulate the heart using either constant current or constant voltage output. The enhanced stimulator now can be used in both EP (electrophysiology) diagnostic studies of the heart and pacemaker implantations where measuring voltage thresholds are fundamental. The stimulator is integrated with the company's EP-WorkMate Electrophysiology Workstation, as well as other diagnostic technologies used in the monitoring and diagnosis of arrhythmias in the heart.
ev3 (Plymouth, Minnesota) said it has received CE mark approval for use of its Protege GPS Nitinol Self-Expanding Tapered Stent for treatment of carotid artery disease. The Protege GPS stents are designed to provide a more appropriate fit to the varying diameters of diseased vessels to be used as a minimally invasive procedure to open blockages in carotid arteries and prevent stroke. The Protege GPS, made of nitinol, is cleared for malignant biliary use in the U.S.
Medtronic (Minneapolis) reported FDA approval and U.S. market release of the Sprint Fidelis family of defibrillation leads. At 6.6 Fr in size, Sprint Fidelis leads are the world's smallest right ventricular defibrillation leads, the company said, allowing for compatibility with 7 Fr introducers. The small size of the Sprint Fidelis helps improve passage into a patient's venous system for an easier implant, and minimizes venous obstruction, Medtronic said. Sprint Fidelis leads will be available in both quadripolar and tripolar configurations, with active and passive fixation options. The Sprint Fidelis also has received the CE mark in Europe and is nearing market release, according to Medtronic.
Medtronic Vascular (Santa Rosa, California) reported that it has completed patient enrollment in the ENDEAVOR III clinical trial in the U.S. The data from the ENDEAVOR III trial will be used to support U.S. product approval of the company's Endeavor drug-eluting coronary stent. ENDEAVOR III is a randomized trial evaluating the safety and efficacy of the Endeavor stent vs. the Cypher Sirolimus-eluting stent marketed by Cordis (Miami Lakes, Florida), a Johnson & Johnson company. The equivalency study includes 436 patients (327 receiving the Endeavor stent) with a primary endpoint of in-segment late lumen loss at eight months.
MIV Therapeutics (Vancouver, British Columbia) reported the completion of in vivo safety studies on its biocompatible Hydroxyapatite (HAp) nano-film coating, designated for passive application on cardiovascular stents and other implantable medical devices. The scientific panel conducting the study concluded: "HAp coated stents passed all outlined safety criteria and there were no signs of adverse reaction to the coating. After the 28-day implant, coated stents performed favorably against control stents in that they displayed an advanced stage of healing, with complete endothelialization, a stable neointima and very few luminal monocytes." HAp-coated stainless steel and cobalt-chromium coronary stents were evaluated through in vivo tests in rabbit iliac arteries to determine implant safety and tissue response.
Siemens Medical Solutions (Malvern, Pennsylvania) said its Angiography and X-ray Division has introduced Interventional Cardiac 3D (IC3D) technology to create 3-D images of the coronary vessels in the heart. When paired with an Axiom Artis imaging system from Siemens, IC3D allows cardiologists to view the coronaries in 3-D with as few as two images, leading to precision in determining appropriate stent size and length, faster examination times, the use of less contrast medium and lower radiation dosages.
Smiths Medical (Rockland, Massachusetts) has introduced the Snuggle Warm Convective Warming Sterile Cardiac Blanket. Designed to maintain patient temperature during cardiac surgery and help the patient arrive in the recovery room or intensive care unit normothermic, the Snuggle Warm blanket surrounds the patient's lower body with warm air to minimize patient heat loss in perioperative settings. This blanket also provides visibility of the femoral artery through a groin window, folds to allow access to the groin or leg for additional vein harvesting, positions easily in the surgical field without the need for tie-downs, and is provided with a sterile hose that allows flexibility in the placement of the temperature management unit outside of the sterile field. The Snuggle is compatible with Equator EQ-5000 and Snuggle Warm SW-4000 Convective Warming Systems and is made from the same flexible material which conforms to the patient in the surgical field and is resistant to tears and punctures.
St. Jude Medical (St. Paul, Minnesota) reported European CE mark approval for the QuickSite 1056T bipolar left-heart pacing lead. The company said it is the first cardiac resynchronization therapy (CRT) lead to offer physicians a composite body for superior handling and an S-shaped distal tip for stability, along with bipolar pacing capability. The V-V timing feature allows physicians to adjust the delay between contraction of the left and right ventricles, as well as choose which chamber is paced first. The QuickSite 1056T lead, with a diameter of 5.5 Fr, is designed for placement in the coronary sinus to enable left-ventricular pacing in CRT applications. The lead incorporates a polyurethane body that transitions to a distal silicone tip section designed for optimal pushability, torque transfer and tip flexibility. The QuickSite 1056T lead is designed to work with the Epic HF CRT-D and the Atlas+ HF CRT-D. It also will work with the Frontier II biventricular pacemaker, recently approved by the FDA
Vasomedical (Westbury, New York) said that two separate presentations on the clinical improvements achieved with EECP (enhanced external counterpulsation) therapy in the treatment of heart disease were presented at the European Society of Cardiology congress. Angela Brown, MD, of the department of cardiology at Beaumont Hospital (Dublin, Ireland), presented the results of a study demonstrating that diabetics with coronary artery disease (CAD) appear to respond less than non-diabetic CAD patients while undergoing EECP therapy, but do obtain a significant reduction in angina symptoms following treatment. Ozlem Soran, MD, assistant professor at the University of Pittsburgh Medical Center's Cardiovascular Institute, presented a study showing that despite differences in health conditions, women respond just as well as men to EECP therapy.
Vitatron (Arnhem, the Netherlands), a European-based subsidiary of Medtronic (Minneapolis), reported the recent FDA approval and U.S. launch of the Vitatron T-series pacemaker, an advanced implantable heart device based on a digital processing platform. Digital technology enables the T-series device to collect heart rate information more quickly and precisely than other pacemakers, the company said. The device's data processing speed also translates into faster device checks for patients, as physicians can get device data reports in less than 20 seconds, Vitatron said. It said the efficiency gains of digital data collection also contribute to the T-series' expected lifespan of 9.3 years. The T-series device features dual-channel electrograms, which allows physicians to review heart rhythm patterns simultaneously in the upper and lower chambers of the heart.
Zargis Medical (Princeton, New Jersey), a subsidiary of Speedus, said it has received FDA clearance to include a graphical display of the median energy level, timing and duration of suspected heart murmurs during specific segments of the diastolic and systolic intervals of heartbeats recorded through the Zargis Acoustic Cardioscan. The new displays will better represent the distribution of acoustic energy of the heart for each recorded location and help physicians characterize suspected murmurs in terms of onset, duration and loudness. The company said this clearance represents one of the planned development milestones required for a full commercial rollout of Cardioscan.