CardioDynamics (San Diego), the primary developer of Impedance Cardiography (ICG) technology, a powerful predictor of short-term outcomes for heart failure patients, reported that its third-generation product platform, the BioZ Dx, has received 510(k) market clearance from the FDA.
The company said the BioZ Dx represents the first phase of a co-development partnership between it and Philips Medical Systems (Andover, Massachusetts) that leverages each company's technology and expertise. Additionally, the BioZ Dx will be upgradeable to include Philips' 12-lead electrocardiogram (ECG) technology in late 2005.
CardioDynamics CEO Michael Perry explained the significance of the partnership with Philips, saying there are two significant levels to the incorporation of that company's technology into the BioZ Dx system. On the first level, he said that the system "provides the physician[s] with additional capability in a single product, they perform both the electrical and mechanical assessment of the heart in one device. In a space-constrained environment, that's an important feature."
More strategically, Perry said, the system pairs a standard-of-care measurement the ECG with the company's new measurement the ICG into a system that allows physicians to become familiar with the technology and hopefully come to rely upon it over time. "As the physician is utilizing the ECG side of that product each and every day," he said, "it will only serve to reinforce their usage of our [ICG] device."
He added the collaboration with Philips provides CardioDynamics with substantial reduction in product development cost and reduced time to market.
Perry said the new processing provides "enhanced stability, accuracy and reproducibility in a broader range of patient monitoring conditions." He said that this new processing would allow for a "stronger impedance cardiography measurement device." He said the Dx will be able to work on more challenging patient conditions than past generations of the platform, including arrhythmias (atrial fibrillation, supraventricular arrhythmia), wide QRS amplitudes, patients with AV sequential pacemakers, weak signal patients, and noisy signal patients. "Those signals are going to be picked up much more strongly by this device than with prior generations," he said.
In addition to the significant signal processing improvements and future 12-lead ECG capability, the Dx system also features an integrated full-page thermal printer, color display screen, and a new reporting function that allows physicians to automatically compare a patient's last ICG report to the current ICG report. This feature allows clinicians to easily identify whether a patient responded to therapy or whether their heart function has worsened or improved.
Elsewhere in the product pipeline:
AusAm Biotechnologies (New York) reported that its Accumin test for detection of the protein albumin in urine would be offered by Quest Diagnostics (Tetersboro, New Jersey). The presence of relatively high levels of albumin in the urine, a condition known as microalbuminuria, is an indicator of elevated risk for developing cardiovascular disease complications and kidney disease. The test will be available to hospital-based physicians nationwide in 1Q05 through Quest. Terms of the transaction were not disclosed.
Biotronik (Lake Oswego, Oregon) reported the first implant for a clinical investigation designed to demonstrate efficacy of both its Stratos LV and Protos DR/CLS (closed loop stimulation) pacemakers in congestive heart failure (CHF) patients who have undergone AV nodal ablation (ablate and pace) for persistent or permanent symptomatic atrial fibrillation (AF) with poorly controlled rapid ventricular heart rates. William Bailey, MD, of the Heart and Vascular Center (Lake Charles, Louisiana) implanted a Protos DR/CLS pacemaker in a biventricular (BiV) configuration in a 72-year-old male with a history of NYHA Class III CHF and permanent AF. The AVAIL CLS/CRT study randomizes patients into three groups: Stratos LV biventricular implants; Protos DR/CLS biventricular implants; and Stratos LV pacing in a standard right ventricular configuration as the control group. The primary endpoint is to demonstrate the clinical benefit of biventricular pacing for the Class II and Class III heart failure population who also have permanent AF and have undergone AV nodal ablation. The results will be compared to the traditional right ventricular pacing study arm.
Cardiome Pharma (Vancouver, British Columbia) and its co-development partner, Fujisawa Healthcare (Deerfield, Illinois), reported results from their recently completed Phase III multi-center clinical study, ACT 1. ACT 1 measured the safety and efficacy of intravenous RSD1235 in 416 patients with atrial arrhythmia. The study showed that of the 237 patients with recent-onset atrial fibrillation (AF), 52% of those receiving an IV dose of RSD1235 converted to normal heart rhythm, as compared to 4% of placebo patients. The ACT 1 study data suggests that RSD1235 also is safe and well tolerated in the targeted patient population. The primary endpoint in ACT 1 was conversion of recent-onset AF to normal heart rhythm for a period of at least one minute post-dosing within 90 minutes of the start of dosing.
Cholestech (Hayward, California) reported the results of a Mayo Clinic (Rochester, Minnesota) study that suggests that a non-invasive fingertip test for which it is the distributor can identify coronary disease at its earliest stages and may provide a new point-of-care test for physicians to use in their offices. The test, called the Endo-PAT 2000, is used to assess vascular endothelial dysfunction, an early indicator of atherosclerosis. It was developed by Itamar Medical (Caesarea, Israel). About 30 studies are under way to test the Endo-PAT 2000, and this most recent study's findings were published in December in the Journal of the American College of Cardiology. Cholestech has set high expectations for the impact the test could have on cardiovascular testing. President and CEO Warren Pinckert said the test "could change the face of risk assessment and then monitoring people after they've had an event." According to the Mayo Clinic, "Endothelial dysfunction is the earliest measure of functional abnormality in the blood vessels, so coronary endothelial dysfunction signals the beginning stages of atherosclerosis and heart disease." In its study, researchers investigated the value of the Endo-PAT to assess the relationship between dysfunction in the heart region and dysfunction in the extremities. Through testing the 94 patients in the study in the catheterization lab, coronary endothelial dysfunction was found in 55 patients. Cholestech said that by comparing those results against the Endo-PAT system, "the researchers found a threshold value for the fingertip test that would have identified the majority of the patients with early heart disease." The Mayo Clinic concluded in its study that the findings "indicate a potential role for RH-PAT as a test to identify individuals like this prior to an invasive procedure such such as an angiogram."
Corautus Genetics (Atlanta) reported the publication of pre-clinical results of its gene transfer technology administered via drug-eluting stents. In a separate project, Corautus' technology is being tested in a Phase IIb trial, GENASIS (Genetic Angiogenic Stimulation Investigational Study), which is enrolling up to 404 patients with Class III or IV angina in about 25 cardiac medical centers in the U.S. In the GENASIS trial, defined doses of vascular endothelial growth factor-2 (VEGF-2) in the form of naked DNA plasmid, a non-viral vector, are delivered to diseased heart muscle tissue via Boston Scientific's (Natick, Massachusetts) Stiletto endocardial direct injection catheter system. In the pre-clinical study reported in a recent issue of Circulation, a team of researchers tested VEGF-2 gene transfer in an animal model of stent thrombosis. The results demonstrated for the first time that VEGF-2 could be delivered to blood vessels using drug-eluting stents and that this delivery led to accelerated growth of healthy endothelial cells while reducing pathological thickening of the artery associated with restenosis. Separately, Corautus Genetics said Circulation published pre-clinical results of the company's gene-transfer technology administered via drug-eluting stents. Data showed that VEGF-2 could be delivered to blood vessels using drug-eluting stents and that the delivery led to accelerated growth of healthy endothelial cells while reducing pathological thickening of the artery. Corautus' technology is being tested in a Phase IIb trial that is enrolling up to 404 patients with Class III or IV angina in about 25 cardiac medical centers in the U.S.
CoreValve SA (Paris) reported that it has received approval from the German government (Bezirksregierung Koln, state of Nordrhein-Westfalen, Cologne) to begin a clinical trial of its ReValving System to non-surgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery. Previously, CoreValve received local institutional review board approval from The Heart Center (Seigburg, Germany), where the clinical trial will take place. The principal investigator will be Eberhard Grube, MD, chief of cardiology at The Heart Center and a consulting professor of medicine at Stanford University (Palo Alto, California), who will perform the ReValving procedure. The CoreValve procedure with the CoreValve Percutaneous ReValving System can be performed in a cardiac cath lab just like angioplasty and stenting, resulting in less trauma to the patient and cost savings to the healthcare system, the company said. CoreValve also reported that it has been issued U.S. patent No. 6,830,584, protecting the CoreValve Percutaneous ReValving System.
CryoCath Technologies (Montreal) said additional data on a feasibility study using its Arctic Circler Balloon catheter to treat atrial fibrillation (AF) was presented at the Boston Atrial Fibrillation Symposium Jan. 15. Of 16 patients who reached the six-month follow-up point, 13 were AF-free, with 11 off specific anti-arrhythmic drugs. Of the three patients technically deemed "treatment failures," one was retreated and is AF-free; the other two are both off drugs, have had a significant reduction in burden, do not warrant re-treatment and are considered clinically successful. There were no device-related serious adverse events. CryoCath said it will file for a CE mark during 1Q05. Enrollment in an investigational device exemption study is expected to begin in 1Q05 upon FDA approval of CryoCath's toolbox approach that will now include Arctic Circler Balloon, Arctic Circler Linear and Freezor MAX.
CryoLife (Kennesaw, Georgia), a biomaterials and biosurgical device company, unveiled updated results from its registry that tracks the clinical performance of its cryopreserved human heart valve allografts, used to project long-term performance by actuarial analysis. Results indicate 100% of pediatric patients and 98% of adult patients receiving human heart valves processed by the company were reported free from thromboembolic (blockage) events for 10 years following implantation. These and other patient outcomes were detailed in the company's CryoValve Human Heart Valve Clinical Experience 2004 report, a 10-year tracking of more than 2,600 patients receiving human heart valves processed by CryoLife. Additionally, 95% of adult recipients of heart valves processed by the company were reported to be free from endocarditis, an inflammation of the lining of the heart and its valves, 10 years following implant. For pediatric patients, 99% were reported to be free from endocarditis during this period. And freedom from valve-related death within 10 years of implantation was 93% and 97% for adult and pediatric patients, respectively. CryoLife reports more than 100,000 patients having received its processed tissues in cardiac, vascular, and orthopedic reconstruction surgeries since its founding in 1984.
Dade Behring (Deerfield, Illinois) reported FDA clearance for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism (deep vein thrombosis or pulmonary embolism). The clearance included performance data with a defined cutoff value for the Dade Behring BCS System and Sysmex CA-1500 System. The assay is also for use on Dade Behring's BCT System, and Sysmex CA-7000 and CA-560 Systems.
Edwards Lifesciences (Irvine, California) said it previewed its FloTrac sensor, a new minimally invasive hemodynamic monitoring device, at the Society of Critical Care Medicine's 34th Critical Care Congress last month in Phoenix. The Edwards FloTrac sensor provides key continuous cardiac measurements by accessing data directly from an arterial line. Most critically ill or surgical patients in hospitals already have an arterial line in place to measure basic cardiovascular information and to draw blood, making the FloTrac sensor easy to use. The sensor enables clinicians to elect a less-invasive option for those patients who need hemodynamic monitoring, but who may not require all of the parameters offered by Edwards' line of Swan-Ganz catheters. Edwards also launched at the meeting its Vigilance II monitor, the next generation of continuous cardiac output and oximetry monitors for use with Swan-Ganz catheters. The Vigilance II monitor features a streamlined design, a large, color, customizable display and a data graph to simplify data and provide a clear picture of hemodynamic performance.
MedicalCV (Minneapolis) said it received FDA 510(k) clearance to market its AtriLaze Surgical Ablation System for use on cardiac tissue in surgery. The company expected to begin marketing its AtriLaze System via a direct U.S. sales force in January. The laser device is used to ablate or cause scarring of soft tissue, with the long-term goal of treating atrial fibrillation.
Medtronic (Minneapolis) reported the first patient enrollment in a new controlled clinical study to evaluate the safety and efficacy of a procedure in which a heart surgeon uses saline-irrigated radio frequency (RF) ablation technology to treat atrial fibrillation (AF) at the same time they repair or replace a diseased or damaged heart valve. The first randomized procedure was performed by Dr. Michael Moront at Toledo Hospital of Ohio, one of several U.S. centers participating in the study. The CAFE (Cardioblate Atrial Fibrillation) study is the first prospective, randomized, blinded trial designed to study surgical ablation for the treatment of AF. The CAFE study will enroll adult patients suffering from both heart valve disease and AF. The Medtronic Cardioblate system creates lesions in the heart's upper chambers to block transmission through the tissue of abnormal electrical signals that may cause AF.
Noven Pharmaceuticals (Miami) reported that it has been issued U.S. patent No. 6,805,878, titled "Transdermal administration of ACE inhibitors." The patent relates to a method for delivering a therapeutically effective amount of enalaprilat, the pharmaceutically active form of the drug enalapril, by means of transdermal drug delivery systems. Enalapril is an angiotensin-converting enzyme (ACE) inhibitor generally indicated for the treatment of hypertension and other heart conditions.
SonoSite (Bothell, Washington), a leader in handheld ultrasound systems, said that it has begun customer shipments of the SonoCalc IMT software, enabling physicians to quickly measure the wall thickness (IMT) of the common carotid arteries and assess a patient's risk of cardiovascular disease. Used in conjunction with the Titan system SonoSite's high-resolution, hand-carried ultrasound technology the SonoCalc IMT software enables physicians to identify disease at an early stage for more effective management. The PC-based software works with digital images downloaded from the Titan system. Kevin Goodwin, president and CEO of SonoSite, said, "This technology offers physicians a low-cost and non-invasive means to identify cardiovascular disease early when it is both treatable and reversible. This is a practical and innovative primary care application of ultrasound which we believe can play a major role in decreasing the long-term risk of heart attack or stroke by identifying patients with subclinical disease." Introduced at the 2004 Scientific Sessions of the American Heart Association (Dallas) in November, SonoSite's SonoCalc IMT automated edge-detection technology provides physicians with the ability to analyze the IMT of a patient's carotid artery and compare it with published population data to generate an individualized cardiovascular health profile report. The software provides fully automated, single-click IMT measurement capability; semi-automated, user-guided IMT sketch or trace measurements for difficult images; statistical analysis of multiple IMT measurements; patient-specific exam electronic file management; and professional report generation summarizing one or more IMT examinations for a particular patient.
Terumo Cardiovascular Systems (Ann Arbor, Michigan) has introduced the VirtuoSaph Endoscopic Vein Harvesting (EVH) System for use in coronary artery bypass grafting (CABG). The minimally invasive device provides an endoscopic approach to saphenous vein harvesting in which one small leg incision minimizes scarring, morbidity and infection associated with traditional longitudinal incisions. The EVH System features disposable endoscopic tools inserted through a small leg incision to dissect and harvest the saphenous vein. An endoscope, designed exclusively for the system by Olympus (Tokyo), enables viewing of the endoscopic procedure in real-time on a monitor. The disposable tools include a trocar, a dissector rod and a harvester rod that enable one-handed manipulation and conversion between tools during the procedure. Terumo Cardiovascular Systems has combined the VirtuoSaph EVH System with the Terumo Endoscopic Simulator, developed in collaboration with Immersion Medical (San Jose, California), a leader in virtual reality medical simulators. The VirtuoSaph Endoscopic Vein Harvesting System will be marketed by Terumo Cardiovascular Systems in the U.S. and by Terumo companies around the world.
By a vote of 8-2, with one abstention, the FDA's Circulatory System Devices panel in mid-January recommended approval, with a small number of conditions, for the Gore TAG Thoracic Endoprosthesis, developed by W. L. Gore & Associates (Flagstaff, Arizona). If it wins final FDA approval, the Gore TAG would be the first endovascular device approved in U.S. for patients suffering from a thoracic aortic aneurysm (TAA). Of particular note was that the company's premarket approval application went through the FDA's expedited approval process. TAA is generally believed to be significantly under-diagnosed, because three out of four individuals with aneurysms are asymptomatic, Gore said. TAA traditionally has been treated with highly invasive open surgery. The procedure requires the surgeon to make a large incision in the patient's chest in order to sew a synthetic graft in place, which prevents the aneurysm from rupturing. Gore says the TAG device is a significantly less-invasive endovascular strategy. The device is inserted through a small incision in the patient's groin, and a catheter delivery system is guided into position through the patient's arteries under fluoroscopy. Once in position, a reinforced ePTFE(expanded polytetrafluoroethylene) covered, self-expanding nitinol stent is secured inside the weakened section of the thoracic aorta. This creates a new path for blood flow and relines the aorta. The stent-graft excludes the diseased segment from the pressure of blood circulation, thereby reducing the risk of a rupture. Data from the pivotal trial showed that Gore TAG patients after 30 days had less than one-fourth the rate of resultant paraplegia (3% vs. 14%) and one-third fewer strokes (11% vs. 33%) than the patients in the control group treated with the traditional surgical option. The company also reported no aneurysm ruptures in the Gore TAG patients followed through two years.