In early December, Pfizer (New York) reaped a large number of negative headlines when it reported that it had to stop its Phase III ILLUMINATE trial of a drug that it had expected to raise good cholesterol, the halt due to an increased rate of death in those receiving only the investigational drug torceptrapib.
Singulex (Hayward, California), a small biotechnology company, is working on a troponin assay that a new paper demonstrates has promise in detecting the well-known biomarker for heart damage in normal patients. The company plans ultimately to offer the assay to pharmaceutical companies for clinical trial monitoring of adverse heart events and therefore to avoid disappointments, such as those by Pfizer, at a late stage in drug development — and within two to three years for clinical diagnostics. Additionally, pharmas are increasingly calling for such assays for testing of patients to determine potential adverse reactions to an approved drug — a development their liability attorneys probably are actively urging.
Current assays, can typically detect a heart attack four hours or more following a heart attack.
The paper on this assay, the Erenna Bioassay System, recently published in Clinical Chemistry, features research by Alan Wu, PhD, professor of laboratory medicine at University of California, San Francisco. Singulex evaluated Erenna's performance in specimens from healthy individuals and patients with chest pain.
Study findings showed the presence of cTnI in the blood of healthy individuals, established normal baseline concentrations of cTnI, and demonstrated that Singulex's Erenna assay platform was able to detect small changes in concentration levels of cTn1, which could be an early indicator of AMI that is below the current and standard detectable limit of 350ng/L.
Restated, the assay is designed "to incorporate direct, single-molecule detection technology with customized clinical assays that are capable of quantitatively detecting 'therapeutically significant' biomarkers at sub-picogram concentration levels," the company said.
Singulex plans to offer the troponin assay along with an "assay menu" to pharma companies in Q107 via its Erenna platform, Philippe Goix, president/CEO of the company, told Cardiovascular Device Update.
"We need to continue to expand on the … clinical value of troponin," Goix said, saying that the company's strategy will be to enter into a collaboration with a "top medical institution" to further investigate the biomarker.
Singulex also hopes to develop its troponin assay for clinical diagnostic use, and it will "definitely be available for collaboration tied to the diagnostic focus," Goix said.
The company already has developed more than 75 assays for protein and metabolite biomarkers. Singulex also has developed customized assays for pharma companies. All of these assays are available now to pharma companies and universities through the companies Early Technology Access Program, or eTAP.
The Erenna Bioassay System, to be launched this year, will feature a menu of assays derived from these.
Elsewhere in the product pipeline
• Abiomed (Danvers, Massachuset)s reported FDA clerance of its new intra-aortic balloon (IAB), an easy-to-insert, minimally ivnasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function. The new ballon, the company said, successfully demonstrated a life of more than eight million cycles, equating to more than 90 days of continuous operation. In addition to the IAB, the company has developed a combination console platform, the iPulse, currently under regulatory review, to support the IAB. the iPulse console will also support Abiomed's BVS and AB5000 circulatory support systems, as well as new product introductions by the company. The company sadi the IAB technology strengthens its portfolio of products which now includes thre platforms (Impella, iPulse and AbioCor) and consists of seven disposable devices that span the cath lab to the intensive care unit to the surgery suite.
• AngioDynamics (Queensbury, New York) has received 510(k) clearance for Oncobionic to market irreversible electroporation (IRE) - a technology indicated for surgical ablation of soft tissue, including cardiac and smooth muscle. As previously reported, AngioDynamics will acquire Oncobionic upon successful human use of its IRE technology, for which testing is expected to commence in mid-2007. IRE uses needles and image guidance similar to existing thermal ablation technologies, but instead of "cooking" or "freezing" the targeted tissue, IRE disrupts the cell membrane, thereby destroying the targeted cells. In IRE, needle electrodes are placed through the skin by image guidance in the center or at the edge of the targeted tissue. A certain electrical field is then generated within the electrode array, causing permanent nanoscale defects (pores) in the cell membranes. The impaired cells are left in the body to be removed by the body's natural immune system. AngioDynamics develops and manufactures devices that treat peripheral vascular diseases and other non-coronary diseases.
• ATS Medical (Minneapolis) said it received a notice of allowance from the U.S. Patent and Trademark Office for a key patent application on its anti-coagulation and demineralization of conductive medical devices technology. It expects this patent to issue in early 2007. The ATS technology is used to treat implantable medical devices to minimize blood/platelet interaction with the device. ATS Medical provides products and services focused on cardiac surgery.
• Biophan Technologies (Rochester, New York), in conjunction with Myotech (West Henrietta, New York), recently presented results of animal studies that indicate the potential of the Myo-Vad cardiac support system to treat heart failure. The animal study presented at the recent Cleveland Clinic symposium on heart failure suggests that the Myo-Vad system can improve the ability of failing hearts to pump blood, while simultaneously reducing the stress on the heart that accounts for the vicious, progressive cycle of heart failure, the company said. Researchers found that key biomarkers of heart failure increased in animal hearts with induced heart damage, but decreased in animals whose damaged hearts were supported with the device. The Myo-Vad can be implanted on an arrested or weak heart in about three minutes, restoring cardiac output, Biophan said. It consists of a flexible polymer cup that fits around the heart, compressing and expanding both ventricles. Because it does not come into contact with circulating blood, the device is designed to eliminate the serious and potentially fatal complications of clotting and stroke, bleeding, and infection that plague other ventricular assist devices. Biophan makes products that enable medical systems such as pacemakers, catheters, guidewires, and implants to be safely imaged under MRI.
• Cambridge Heart (Bedford, Massachusetts) reported the publication of a study in the Journal of the American College of Cardiology assessing the utility of Microvolt T-Wave Alternans (MTWA) in predicting risk of sudden death among patients who have previously suffered a heart attack but have preserved cardiac function. This group of patients is outside of the MADIT II and SCDHeFT populations as the study included only patients with a left ventricular ejection fraction (LVEF) greater than or equal to 0.40, while the two studies involved LVEF less than or equal to 0.30 and LVEF less than or equal to 0.35 patients respectively. The results indicate that the MTWA test, using the Cambridge Heart Spectral Analytic Method during low heart rate exercise, identifies those patients who are at elevated risk for sudden cardiac death and therefore may benefit from implantation of a defibrillator. The study was a large cohort study enrolling 1,041 post-MI patients at eight medical centers in Japan. All patients had an LVEF greater than or equal 0.40 and the average LVEF was 0.55. Microvolt TWA testing was performed 48 to 66 days after acute MI, and 10 other risk variables were also evaluated. Cambridge Heart develops products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest.
• Cardiac Science (Bothell, Washington) said it has begun shipments of the Powerheart G3 Plus, a CPR-enhanced addition to its Powerheart automated external defibrillator (AED) that is designed for the public access defibrillation market. The G3 Plus is designed for public places such as schools, shopping malls, private homes (with a doctor's prescription) and corporate offices. Its Rescue Coach voice prompts guide the less experienced rescuer through the steps of cardio-pulmonary resuscitation and defibrillation with calm, direct and comprehensive instructions. Cardiac Science makes a family of advanced diagnostic and therapeutic cardiology devices and systems.
• CardioDynamics (San Diego) reported that the Centers for Medicare and Medicaid Services released the final version of its national coverage decision (NCD) maintaining coverage for high blood pressure, also known as hypertension. The decision will maintain the carrier discretion policy for coverage of ICG for patients' with resistant hypertension, defined as those whose blood pressure is not controlled on three or more medications. This coverage decision for hypertension, along with prior NCD indications for shortness of breath and heart failure will enable both clinicians and patients to benefit from ICG utilization. CardioDynamics makes noninvasive BioZ ICG products and medical device electrodes.
• Cordis Endovascular (Miami Lakes, Florida) reported the launch of two products in the treatment of blocked lower-leg arteries: the FRONTRUNNER(R) XP CTO Catheter and the OUTBACK LTD Re-Entry Catheter. These devices safely place guidewires in narrowed or blocked arteries during minimally invasive procedures that remove blockages and re-establish blood flow. Cordis Endovascular, a division of Cordis (Miami Lakes), supplies interventional and diagnostic products including nitinol and stainless steel stents, vena cava filters, balloon catheters and accessories.
• CoreValve (Irvine, California) reported that its Revalving system was used to percutaneously implant its porcine pericardial tissue bioprostheses over the severely diseased aortic heart valves of four consecutive high-risk patients: two at the HELIOS Heart Center (HHC; Siegburg, Germany) and two at the University of Leipzig Heart Center (Germany). CoreValve said each of the ReValving procedures were performed without the necessity of a surgical cut-down for catheter access, without the use of extracorporeal bypass, and without any other cardiac assistance or even rapid pacing. CoreValve has developed a delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery.
• CryoCath Technologies (Montreal) reported 12-month follow-up data on the feasibility stage of the STOP AF trial. This trial assesses the Arctic Front catheter to treat atrial fibrillation (AF). A total of 33 patients were treated during the feasibility stage. At the six-month mark, eleven of the original 15 patients (73%) were AF free. Of the 11, nine are AF free at 12 months and off anti-arrhythmic drugs (AAD's) and two did not show up for their one year visits. All original 15 patients AF-free at six months and that attended their 12-month visit, remain AF free; all original 15 patients are off AAD's; and all of the remaining 18 patients have similar freedom from AF levels at three and six months and all are off AADs. CryoCath produces cryotherapy products to treat cardiovascular disease, the company said.
• CryoLife (Kennesaw, Georgia) reported FDA 510(k) clearance for its ProPatch Soft Tissue Repair Matrix, a product developed from bovine pericardial tissue used to reinforce weakened soft tissues and providing a resorbable scaffold that is replaced by the patient's own soft tissue. ProPatch also is indicated for reinforcement of soft tissues, including muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. It also can be used to reinforce tissues repaired by sutures or by suture anchors during tendon repair surgeries, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons, according to the company. In 2005, soft tissue repair was a $600 million market in the U.S., anticipated to grow 14% annually until 2010, according to a 2006 report by Millennium Research Group. Millennium estimates that by 2010, the U.S. ventral hernia market alone will approach $350 million with procedures nearing the 300,000 mark annually. CryoLife processes implantable living human tissues for use in cardiovascular, vascular, and orthopedic surgeries throughout the U.S. and Canada.
• EP MedSystems (West Berlin, New Jersey) reported the launch of its MapMate Interface link between its EP-WorkMate Recording System and CARTO XP Navigation and Ablation System. The CARTO XP System, from Biosense Webster (Diamond Bar, California), is a 3D navigation system used in advanced ablation procedures for treatment of patients with irregular heartbeats. The MapMate interface was recently cleared by the FDA. The MapMate Interface between EP-WorkMate and Carto XP System was designed to simplify procedures by having the recording system and the 3D navigation system communicate with each other to combine diagnostic data from each system and eliminate duplicate demographic data entry. Currently most labs must separately enter and manage patient data on their individual recording and navigation systems. By linking the detailed electrograms from sites within the heart to the "roadmap" used in conducting ablation procedures, MapMate Interface allows clinicians to rapidly see complete information to conduct the proper course of treatment, and produce comprehensive case reports from the EP-WorkMate Recording System. EP MedSystems develops cardiac electrophysiology products used in imaging, diagnosing and treating certain cardiac rhythm disorders
• Masimo (Irvine, California) reported that a new independent study, presented at last month's congress of the American Association for Respiratory Care (AARC) in Las Vegas, concluded that the Masimo Blue sensor is the most accurate technology for monitoring babies with cyanotic congenital heart disease. The researchers compared Masimo SET Radical usingMax-I sensor and concluded that only the Masimo Blue sensor demonstrated acceptable accuracy on this patient population. Masimo is focused on the patient monitoring sector.
• MedicalCV (Minneapolis) said that Allen Raczkowski, MD, a cardiothoracic surgeon at Banner Baywood Heart Hospital (Mesa, Arizona), completed the first closed-chest, robotic procedure using the AtriLaze surgical ablation system to treat atrial fibrillation in conjunction with a minimally invasive mitral valve repair. MedicalCV, a cardiovascular surgery device maker, focuses on the development of products designed to improve patient outcomes through the early treatment of cardiovascular disorders and disease, specifically products used by cardiac surgeons to ablate cardiac tissue as a potential means to treat atrial fibrillation.
• Micrus Endovascular Corporation (San Jose, California) reported positive initial results from a single-center study of neurovascular aneurysms treated with Micrus Endovascular's Cerecyte microcoils indicating an excellent safety profile and a recanalization rate below historical published rates for bare platinum coils. Cerecyte microcoils incorporate a bioactive filament with Micrus Endovascular's 3D microcoils that deploy within a cerebral aneurysm, forming a scaffold that conforms to a wide diversity of aneurysm shapes and sizes. Micrus believes Cerecyte will stimulate a healing response, thus improving outcomes by reducing the rate of recanalization (continued or new aneurysm growth) and the need for re-treatment. Micrus makes both implantable and disposable medical devices used in the treatment of cerebral vascular diseases.
• MIV Therapeutics (MIVT; Atlanta) said a comparative animal study of two of its novel polymer-free drug-eluting stent coating technologies has concluded with positive results. The study compared stents coated with MIVT's polymer-free drug-eluting technologies to Johnson & Johnson (New Brunswick, New Jersey) Cypher stent. The study demonstrated that both of MIVT's polymer-free, Sirolimus eluting coatings are at least as good as Johnson & Johnson's Cypher Stent, MIVT said. MIV Therapeutics is developing a next-generation line of advanced biocompatible coatings for passive and drug-eluting applications on cardiovascular stents and a broad range of other implantable medical devices. The company's ultra-thin coating formulation is designed to protect surrounding tissue from potentially harmful interactions with bare metallic stents.
• Possis Medical (Minneapolis) reported the first human use of its GuardDOG Occlusion Guidewire. This product is designed to control blood flow through blood vessels during peripheral endovascular procedures, offering a 0.035"-based guidewire with a CO2-filled occlusion balloon. Possis will conduct market evaluations at select medical sites to support full U.S. market release of the system. Possis creates devices for the cardiovascular and vascular treatment markets.
In other news from Possis, the company reported receiving FDA approval for its new AngioJet Ultra Thrombectomy System, calling it the next-generation, completely re-engineered version of Possis' AngioJet Rheolytic Thrombectomy System. AngioJet is marketed for blood clot removal (thrombectomy) from arterial and venous blood vessels. The new Ultra System features a simple and fast setup process, the flexibility to use a broad range of catheters, a sleeker design, lighter weight, and handling improvements that make it significantly easier to maneuver than the previous AngioJet drive unit. Features of the advanced system include a simple setup process; flexibility to use a broad range of catheters, and a "sleeker" design and lighter weight. Ultra is 46% lighter than the previous AngioJet drive unit and its ergonomic design make it easier to move around the hospital. Possis said it will conduct market evaluations of the Ultra System at key sites throughout the U.S., with full market release set for Summer 2007. Possis manufactures and markets cardiovascular and vascular treatment devices.
• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of an insulation material for cardiac leads used with pacemakers and implantable cardioverter defibrillators (ICDs). Optim lead insulation is the first silicone-polyurethane co-polymer material created specifically for cardiac lead use, the company said. The new Optim insulation is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation. Optim insulation is a new hybrid insulation material, blending the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane. St. Jude Medical is introducing Optim lead insulation on two of its newest leads, the Riata ST Optim ICD lead and the Tendril ST Optim pacing lead. A lead is a thin insulated wire that is placed through the vein as part of a pacemaker or ICD implantation procedure. Its tip is attached to the heart tissue, and its other end connects to the pacemaker. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device. St. Jude Medical is focused on cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.
• Thoratec (Pleasanton, Califronia) reported completing the subbmission of its premarket application seeking bridge-to-transplanation approval for its HeartMate II LVAS (left ventricular asisst system ) by filing the clinical summary and draft final labelinig mocdule. The PMA filing is based on data from 133 BTT opatients representing more than 57 years of cumulative suspport. Days of supp[ort ranged from one to 568 days. The HeartMate II is a continuous flow device deisgne dto provide long-term cardiac support for advanced-stage heart failure patients.
• Viasys Healthcare (Conshohocken, Pennsylvania) has received FDA 510(k) clearance for its Sonara and Sonara/tek digital Transcranial Doppler (TCD) systems. Viasys introduced both TCD systems Wednesday at the Medica Healthcare meeting in Düsseldorf, Germany. TCD is a noninvasive method of measuring blood flow velocities in the arteries of the brain using ultrasound Doppler technology. Sonara and Sonara/tek systems were developed with a new digital data acquisition approach that is designed to provide much higher resolution data than has ever been available. The Sonara product is a fully integrated system, while the Sonara/tek is a Doppler module that allows connectivity to a PC or Viasys's current TCD products.Zoll wins Canadian approval
• Zoll Medical (Chelmsford, Massachusetts) received a Medical Device License from Health Canada for its R Series, which Zoll said is the first and only "Code-Ready" defibrillator that can help improve in-hospital resuscitation efforts. Richard Packer, president/CEO of Zoll, said, "We define 'Code-Ready' as a device that is simple and always ready to use. The R Series offers a OneStep system that simplifies and speeds up deployment of pacing and defibrillation therapy. It also offers comprehensive, automated readiness checks designed to maximize the readiness of the R Series to help clinicians when they need it most. The company said the R Series also offers tools to help clinicians with CPR performance, "which is important because more than half of in-hospital codes involve non-shockable rhythms and, in such cases, the only treatment for these rhythms is high-quality CPR with minimal interruptions." The R Series also offers See-Thru CPR functionality that helps clinicians reduce interruptions. While clinicians are viewing the ECG on a monitor/defibrillator, artifact (i.e., "noise") from manual chest compressions makes it difficult to discern the presence of an organized heart rhythm unless compressions are halted. See-Thru CPR filters out this artifact so that clinicians can view an underlying rhythm without stopping chest compressions. A visual aid known as the CPR Index that allows clinicians to see how well they are performing the rate and depth of chest compressions in real time. This index, along with optional audible prompts such as "Push Harder" and "Good Compressions," helps clinicians improve CPR performance by integrating rate and depth into a single indicator, Zoll said. With this feedback, clinicians know how well they are performing compressions and can quickly adjust their compressions to improve blood flow. The R Series also checks more than 40 measures of readiness, including the presence of the correct cables and electrodes, the type of electrode and other key electronics, according to Zoll.