PharmaSonics (Sunnyvale, California) reported final results for SILENT, the Phase I registry of the company's Intravascular Sonotherapy System for restenosis following coronary stenting. Sonotherapy, which employs a selective spectrum of therapeutic ultrasound energy delivered through a standard catheter, is under investigation for reducing the incidence of restenosis in patients treated with coronary stents.The early results of SILENT previously led to FDA approval of the ongoing SWING trial, a Phase II pivotal trial of sonotherapy for the prevention of stent restenosis in patients with newly implanted (de novo) stents. SILENT (Sonotherapy for In-Lesion Elimination of Neointimal Tissue) examined short- and mid-term safety and clinical feasibility of intravascular sonotherapy to prevent restenosis in native coronary arteries immediately following stent implantation.
The trial comprised single-lesion treatment of 102 patients at 11 sites worldwide, of which 93 received complete Sonotherapy treatment, with only 10.8% of them requiring target lesion revascularization (TRL) at the nine-month end point of the trial. Six-month data resulted in CE mark approval. PharmaSonics develops therapeutic ultrasound devices representing breakthroughs in transducer miniaturization while maintaining high acoustic emissions.
Also in the product pipeline:
Arrow International (Reading, Pennsylvania) reported the successful implant of its LionHeart, a fully implantable Left Ventricular Assist System (LVAS), last month in Pavia, Italy. This means five European locations have implanted the LionHeart. A total of 22 patients, 15 in Europe and seven in the U.S., have received the LionHeart. The first patient to receive a LionHeart implant on Oct. 26, 1999, had surgery this October to remove the device due to the development of small amounts of blood leaking from the pump into the compliance chamber. The patient's natural heart had recovered sufficiently over the nearly two years of assistance that a replacement pump was not required. The LionHeart device has no power lines or cables protruding through the skin, eliminating a potential source of infection. It is fully implanted in the body and does not replace the heart, but assists in the pumping function of the left ventricle. The device is electrically driven by a wearable battery pack that transmits power non-invasively through the skin to charge internal batteries. Arrow develops a range of clinical catheters and related products for critical and cardiac care.
Aventis Pharmaceuticals (Bridgewater, New Jersey), the U.S. pharmaceutical business of Aventis Pharma AG, reported a landmark, 8,000-patient clinical trial designed to advance the standard of practice for acute coronary. SYNERGY (Superior Yield of the New Strategy of Enoxaparin, Revascularization & GlYcoprotein IIb/IIIa Inhibitors), a multicenter international trial, will study the combination of Lovenox (enoxaparin sodium) Injection, a low-molecular-weight heparin, with new antiplatelet drugs patients with acute coronary syndromes (ACS). The trial is to evaluate the efficacy and safety of Lovenox vs. unfractionated heparin as first-line management in higher-risk ACS patients. The SYNERGY trial is a continuation of the NICE 1, NICE 3 and NICE 4 trials, which studied the safety of using Lovenox for coronary intervention and combining Lovenox with a Gp IIb/IIIa inhibitor. Patients will receive treatment with subcutaneous Lovenox (1mg/kg sc every 12 hours) or unfractionated heparin. The duration of treatment with Lovenox or heparin will be until the completion of percutaneous coronary intervention (PCI) or for patients who do not require PCI, as long as deemed necessary.
Cambridge Heart (Bedford, Massachusetts) said that a Current Procedural Terminology (CPT) code with a specific Medicare payment amount for its Microvolt T-Wave Alternans testing has been published in the Federal Register. Effective Jan. 1, CPT code 93025 may be billed electronically. The national Medicare payment amount for the test will be $263.53. The code is unique to Microvolt T-Wave Alternans and may be used alone or in conjunction with other diagnostic cardiovascular tests when submitting for reimbursement of claims to either Medicare or private insurers. The Cambridge Heart Microvolt T-Wave Alternans Test measures subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. Extensive research has shown that patients with symptoms of or at risk of life threatening arrhythmias who test positive for Microvolt T-Wave Alternans are at significant risk for subsequent sudden cardiac events, including sudden death.
CardioDynamics International (San Diego, California) received FDA 510(k) clearance for its second generation BioZ.com II system. Shipments will begin late in the company's fourth fiscal quarter of 2001. The new BioZ.com II offers notable design features including BioZ Crystal Signal Stabilization (CS2) and BioZ FlexReport software. The addition of CS2 to the existing DISQ (Digital Impedance Signal Quantifier) technology will allow for enhanced signal stability. The FlexReport allows physicians to design reports customized to meet individual clinical needs. The elements of the BioZ.com II were designed for integration into the original BioZ.com, the BioZ dTEL, and future products. CardioDynamics said this regulatory approval and the advancements included in this new generation of ICG monitoring eliminate the near-term need to pursue BioZ dTEL product clearance. The BioZ.com II will be the company's initial solution for the dialysis market.
CV Therapeutics (Palo Alto, California) said that in an open-label, dose-ranging Phase II trial in patients with atrial fibrillation or flutter, CVT-510 consistently reduced heart rate from baseline without decreasing blood pressure. The company said it now will initiate a broad Phase IIb development program aimed at defining an optimized dosage regimen. Current trials for CVT-510 include a Phase III trial in patients with PSVT and Phase II trials in patients with atrial fibrillation. Clinical studies conducted with intravenous CVT-510 suggest that it may slow the speed of AV nodal conduction by selectively stimulating the A1 adenosine receptor, and could avoid blood pressure lowering because it does not stimulate the A2 adenosine receptor. Thus, the company said it may be possible to use intravenous CVT-510 for rapid intervention in the control of atrial arrhythmias without lowering blood pressure. CV Therapeutics also said it had received a notice of allowance from the U.S. Patent and Trademark Office for a patent application titled "Partial Fatty Acid Oxidation Inhibitors in the Treatment of Congestive Heart Failure." Allowed claims include the use of all partial Fatty Acid Oxidation (pFOX) inhibitors, including ranolazine, for the treatment of congestive heart failure. Ranolazine has not been approved for marketing by the FDA or other foreign agencies, but is being investigated in clinical trials subject to a U.S. investigational new drug and applicable foreign authority submissions. CV Therapeutics is focused on the development of small molecule drugs for the treatment of cardiovascular diseases.
Data-Ray (Westminster, Colorado) presented its Precision 1M at last month's meeting of the Radiological Society of North America in Chicago, Illinois. An LCD flat panel with more than 1,554 visible gray shades, it provides greater grayscale depth for precise diagnostic imaging. LCD flat panels typically display 766 or fewer visible gray shades. The advanced high gray-shade technology for enhancing an existing LCD panel was developed by SpectraTech (Japan) and licensed to Data-Ray. Precision 1M also has a scaling function to work with a variety of systems from 30 kHz to 80 kHz. It is suited for fluoroscopic, computed tomography, magnetic resonance, cardiac and other diagnostic images with up to 1280 x 1024 resolution.
Durect (Cupertino, California) reported research results showing in animal models that new blood vessels are formed and that blood flow to an ischemic heart can be restored following targeted delivery of fibroblast growth factor to the heart. These results are from an ongoing research collaboration initiated in 1998 between Durect and the department of pharmacology and toxicology at the Cardiovascular Research Institute of the University of Maastricht in the Netherlands, focusing on targeted chronic administration of compounds to the diseased heart.
GlaxoSmithKline (London, UK) reported FDA approval of Coreg (carvedilol) for the treatment of severe heart failure. Coreg is already approved for the treatment of mild to moderate heart failure. Also, Coreg is now the only beta-blocking agent indicated to increase survival in mild, moderate, and severe heart failure patients, the company said. Coreg blocks all three receptors believed to play a role in the progression of heart failure. The FDA approval is based on a review of data from the COPERNICUS (CarvedilOl ProspEctive RaNdomIzed CumUlative Survival) trial, which showed that treatment with Coreg reduced the risk of death in patients with severe heart failure by 35% compared to placebo. COPERNICUS was a multicenter, double-blind, randomized, controlled trial of Coreg vs. placebo involving more than 2,200 patients in some 300 hospitals in 21 countries.
Guidant (Indianapolis, Indiana) said it has launched its Multi-Link Tristar coronary stent system in Japan. The product is available in low profiles and includes a broad range of sizes: diameters from 2.5 mm to 4.0 mm and lengths ranging from 8 mm to 28 mm. "Because this system is offered in multiple lengths and diameters, we now have the potential to treat significantly more Japanese patients," said Dana Mead Jr., president of Guidant's Japan-Asia/Pacific business.
LightLab Imaging (Westford, Massachusetts) began human cardiovascular studies using its Optical Coherence Tomography (OCT) ultra-high resolution imaging platform and its .014" ImageWire. The study being conducted at the Siegburg Heart Center in Germany. The OCT platform uses advanced photonics and state-of-the-art signal processing techniques to bring microscopic imaging into the body. Using a single strand of optical fiber .006" in diameter, the LightLab .014" ImageWire enables clinicians to obtain images of coronary anatomy at resolutions approximately 10 times higher than any conventional imaging technology currently available. OCT uses infrared light instead of sound waves. The much higher bandwidth of light enables the OCT platform to achieve image resolutions of 10 micrometers to 12 micrometers vs. 100 micrometers for ultrasound. LightLab develops Optical Coherence Tomography for medical and biological applications.
Quinton (Bothell, Washington) released an electrocardiograph (ECG) unit, the QCG 740, a unit that acquires 10-second sections of ECG data and analyzes results for irregularities. The QCG 740 is the first product in a new family of Quinton cardiographs. The unit is designed for rapid input of patient demographics and acquisition of the resting ECG. The detection circuit digitizes at 10,000 samples per second to detect and exclude even the newest pacemaker signals to speed analysis. It features a wireless option to transmit data from the patient to the cardiograph. The patient can be connected to a 10-wire, true 12-lead transmitter that sends the data to the QCG 740 via advanced telemetry technology operating in the medical telemetry range. This technology is compatible with common hospital systems to prevent interference. A direct-connect serial port or an optional modem can connect the QCG 740 to an approved ECG management system. The modem can also be used to transmit the test data via phone line to another QCG 740 unit.
St. Jude Medical (St. Paul, Minnesota) reported the first implant of its Identity XL DR pacemaker, which took place at Kerkhoff Heart Center (Bad Nauheim, Germany). The Integrity pacemaker includes the company's AFx feature set, designed to better manage pacemaker patients suffering from atrial fibrillation. The family of pacemakers combines St. Jude's bradycardia technologies in a single platform. The Identity family includes three models, the DR (a dual-chamber pacemaker of 8 cc, 18 g size), the XL DR (a dual-chamber pacemaker with battery components and circuitry designed for long life) and the SR (a single-chamber configuration of 7.9 cc, 17 g size). Identity pacemakers offer features of St. Jude's Integrity AFx and Integrity micro pacemaker families, plus several new diagnostic features, including stored electrograms, Automatic Mode Switch log and AFx histogram.
Synthetic Blood International (SYBD; Costa Mesa, California) said that results from a series of experiments in rats suggest that Oxycyte, SYBD's perfluorocarbon (PFC) based blood substitute and therapeutic oxygen carrier, may be effective in treating strokes. The company said the German experiments consistently showed a significant decrease in necrotic lesion volume or damage to the brain in Oxycyte-treated animals compared to control animals. The MCA occlusion was left in place for eight hours to mimic the clinical situation where there might be a significant delay before a stroke victim might receive successful clot lysis and initiation of reperfusion. Animals breathing 100% oxygen were given a systemic intravenous infusion of 60% Oxycyte or salines. In addition to decreasing the volume of brain tissue damage induced by MCA occlusion, significantly elevated oxygen levels in the brain were found in Oxycyte-treated animals. SYBD is developing Oxycyte as a blood substitute in surgery and trauma, and as a possible therapeutic oxygen treatment for stroke, heart attacks, malignant tumors, organ preservation for transplantation and ulcers.
Texas Biotechnology (Houston, Texas) said marketing partner GlaxoSmithKline (London) initiated a Phase II trial evaluating Argatroban as a treatment for patients undergoing percutaneous coronary interventions. The 100-patient, open-label trial is designed to test the drug's safety and efficacy as an alternative to heparin, an anticoagulant, and in combination with GPIIb/IIIa receptor antagonists. Argatroban is a synthetic direct thrombin inhibitor that blocks thrombin. Results are expected in the first half of next year.