Boston Scientific (Natick, Massachusetts) received premarket approval from the FDA last month for its EPT-1000 XP Cardiac Ablation System for the treatment of atrial flutter. Successful ablation procedures occur when a linear lesion is created across the tricuspid isthmus. This lesion interrupts the abnormal electrical circuit in a bidirectional manner, allowing the heart to return to normal rhythm permanently. The EPT-1000 XP Cardiac Ablation System allows for 8 mm and 10 mm tip electrodes to be used with up to 100 watts of radio frequency energy to treat atrial flutter.

Separately, Boston Scientific received marketing clearance in Canada for its Taxus Express2 paclitaxel-eluting coronary stent system. The company reported that Health Canada's Therapeutic Products Directorate approved the use of all sizes of the Taxus stent system and that it plans to launch the product immediately in that country.

Taxus is designed to treat coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. It has previously been approved for sale in Europe and other international markets and is awaiting approval by the FDA.

Elsewhere in the product pipeline:

Alteon (Ramsey, New Jersey) said it would continue its clinical development of ALT-711, its lead A.G.E. Crosslink Breaker compound, in both systolic hypertension and heart failure, despite a setback reported earlier this summer. The company in July said use of the product did not result in a statistically significant reduction of systolic blood pressure by office-cuff measurement when compared to placebo at the highest of four doses, 210 mg daily, in its Phase IIb Sapphire and Silver trials. But Alteon said the decision to proceed in both indications is based on continued evidence of the compound's clinical and biological activity, as well as a positive safety profile in a growing body of data.

AngioScore (Alameda, California) reported the successful initiation of the ACE (AngioSculpt Catheter Evaluation) clinical study of its AngioSculpt scoring catheter, with 15 patients having completed treatment. The AngioSculpt includes an angioplasty balloon surrounded by nitinol struts that score arterial lesions as the balloon expands. The catheter is designed to enable dilatation of fibrocalcific lesions at lower pressure, reduce geographic miss due to slipping of traditional angioplasty balloons, reduce elastic recoil in ostial side branches, and facilitate stent placement and expansion. The ACE study examines acute outcomes when AngioSculpt is used for dilatation prior to delivery of bare metal and drug eluting stents, and for dilatation of fibrocalcific lesions, small vessels and in-stent restenosis.

bioM rieux (Durham, North Carolina) said it has received FDA clearance for its VIDAS D-Dimer extended-range D-dimer assay to exclude the presence of suspected deep vein thrombosis and aid in the diagnosis of pulmonary embolism in outpatients.

Cambridge Heart (Bedford, Massachusetts) said it has begun the MASTER (Microvolt T-Wave AlternanS TEsting for Risk Stratification of Post MI Patients) clinical trial. The trial will target post-myocardial infarction (MI) patients whose hearts have been damaged by previous heart attacks. Funded in part by Medtronic (Minneapolis, Minnesota), the study will evaluate the ability of Cambridge Heart's Microvolt T-Wave Alternans (MTWA) Test in predicting which patients may be at greater near-term risk of sudden cardiac death and can therefore have the greatest benefit from ICD implantation. MTWA detects subtle electronic fluctuations in a person's heartbeat that are not visible on electrocardiograms. About 1,800 patients will be enrolled in the MASTER trial. Results of the clinical trial are anticipated in 2006.

CHF Solutions (Brooklyn Park, Minnesota) said that data presented as a poster at late September's Heart Failure Society of America meeting in Las Vegas, Nevada, showed that ultrafiltration using its System 100 Fluid Removal System is a safe and effective means to remove large volumes of excess fluid in patients with heart failure. The system was also found to reduce hospital length of stay by almost two days when compared to the national average of patients receiving conventional diuretic treatment. Data demonstrated that System 100 ultrafiltration treatment lead to improved B-type natriuretic peptide levels and other overall health benefits that were substantial enough to improve patients' heart failure ranking on the New York Heart Association classification scale.

Corgentech (South San Francisco, California) has completed patient enrollment in a pivotal Phase III clinical trial to evaluate its lead product, CGT003, a therapy for the prevention of graft failure following coronary artery bypass graft surgery. CGT003 is an E2F Decoy, an oligonucleotide that binds to and inactivates the pivotal cell-cycle transcription factor E2F, administered in Corgentech's drug-delivery device. CGT003 also is being evaluated in a Phase III clinical trial for the prevention of peripheral arterial bypass graft failure. The FDA will require both the coronary and peripheral Phase III trials for approval, and has granted CGT003 fast-track status for these indications.

Guidant (Indianapolis, Indiana) reported completion of patient enrollment in its second clinical trial designed to evaluate carotid artery stenting as a minimally invasive alternative for patients who are ineligible for current surgical options or at high surgical risk. ARCHeR RX (Acculink for Revascularization of Carotids in High-Risk Patients) is a prospective, nonrandomized, multi-center, single-arm study that enrolled a total of 145 patients in five countries. The trial using Guidant's embolic protection device, the RX Accunet, and a rapid-exchange stent system, the RX Acculink carotid stent was designed to show equivalence in the safety and performance of rapid exchange (RX) versions of the devices with the over-the-wire Accunet and Acculink devices. The primary endpoint for the study is combined death, stroke and myocardial infarction at 30 days.

IDev Technologies (Houston, Texas) received 510(k) clearance from the FDA to market the AKonya Eliminator thrombectomy device in the U.S. The device is cleared for use in the declotting of synthetic dialysis grafts. The AKonya Eliminator is a non-motor driven mechanical thrombectomy device that places the degree of mechanical interaction back into the hands of the clinician, the company said. Axial and rotational manipulation of the device's Thrombasket, a woven mesh structure, serves as the mechanism of action for thrombus maceration. The device's high radial force and vessel wall compliance allow for removal of adherent clot or highly calcified lesions in various dialysis graft sizes.

ImaRx Therapeutics (Tucson, Arizona) said that it initiated clinical trials to investigate the use of its SonoLysis Technology for the treatment of blood clots in kidney dialysis patients whose access grafts have become blocked. The SonoLysis technique combines the use of ultrasound and the company's microbubble clot agent to potentially dissolve vascular thromboses in a relatively simple, non-invasive procedure. ImaRx said it also is planning on filing an investigational new drug application for deep vein thrombosis.

i-STAT (East Windsor, New Jersey) has received FDA clearance to market its 10-minute i-STAT System Cardiac Troponin I (cTnI) test. The company said the test is the first product in the market that offers central laboratory-grade performance at the patient's bedside. Data from the clinical trials showed the test to have the sensitivity necessary to pick up even the slightest elevation, as any troponin is indicative of heart damage. The American College of Cardiology's preferred protocol for assessing patients with chest pain includes a troponin I measurement within 30 minutes of patient presentation at the emergency department. With i-STAT, it is as easy as a single drop of blood and 10 minutes, the company said. Separately, i-STAT reported receiving FDA clearance to market its kaolin-based activated clotting time (kaolinACT) test. The kaolinACT test, along with the celite ACT test already in commercial distribution, is used to monitor the levels of heparin, which is used to significantly reduce the blood's clotting capability during invasive procedures such as cardiac bypass surgery and cardiac catheterization. The company anticipates market introduction of the kaolinACT cartridge in the fourth quarter.

Kensey Nash (Exton, Pennsylvania) has initiated the clinical study of a new version of its TriActiv Balloon Protected Flush Extraction System for carotid stenting procedures. The new device represents an extension of the company's core TriActiv technology that is approved for sale in the European Union and under clinical investigation in the U.S for treating diseased saphenous vein grafts. The TriActiv System for carotids was clinically tested for the first time and was successfully used to provide protection from potential stroke-causing emboli by actively removing debris during carotid stenting procedures.

Molecular Insight Pharmaceuticals (Indianapolis, Indiana) said it will proceed with Phase III trials of its molecular imaging pharmaceutical, (123I)-BMIPP, for the visualization of cardiac metabolism. This decision was based on the positive results of its Phase II studies presented during last month's annual meeting of the American Society of Nuclear Cardiology. The data demonstrate that the uptake of (123I)-BMIPP in patients with ischemia is able to detect an ischemic event up to 24 hours after its occurrence without the need of a stress test. The Phase II data also confirm the findings of a Phase I study that demonstrated the ability of (123I)-BMIPP to routinely deliver high quality images of the heart. The multi-center Phase II study was designed to characterize the cardiac uptake of (123I)-BMIPP in the myocardium in patients who have experienced an ischemic event within 30 hours prior to study drug administration.

Novare Surgical Systems (Cupertino, California) reported the issuance of U.S. patent No. 6,544,274 covering its Cygnet line of dual-action surgical clamps for minimally invasive coronary artery bypass graft surgery, valve replacement surgery and aortic aneurysm repair. Designed to be either rigid or flexible, providing greater access to the surgical field, the Cygnet product line represents a key base-technology for extending Novare's products into new markets, including the treatment of atrial fibrillation.

Pharmacyclics (Sunnyvale, California) reported the publication of data from its Phase I clinical trial of Antrin (motexafin lutetium) Phototherapy, an investigational treatment for atherosclerotic plaque, in a recent issue of Circulation. The open-label, multi-center Phase I drug and light dose escalation study assessed the safety and tolerability of Antrin plus phototherapy in patients undergoing percutaneous coronary intervention with stent deployment. Antrin was found to be well tolerated without serious dose limiting toxicities and side effects were minor with no reported procedure-related vascular adverse effects detectable by angiography. The optimum dosing regimen was found based on evaluation of the treated segment by angiography and intravascular ultrasound.

QRS Diagnostic (Minneapolis, Minnesota) introduced the re-designed OxiCard, a pulse oximeter that provides instant, noninvasive measurement of pulse rates and oxygen saturation in the blood. The re-designed device is built into a compact flash card. All QRS devices can communicate to the company's Office Medic Integrated Data Management System, providing clinicians instant access to physiological data anywhere on their networks.

Quinton Cardiology Systems (Deerfield, Wisconsin) said it has started shipping the new CardioVive AED under the Burdick brand name. The CardioVive AED provides continuous monitoring capabilities during and after resuscitation. The compact unit also features Rescue Ready technology, which performs daily automatic self-tests and monthly full-charge tests of its high voltage circuitry, to ensure that it is always ready for a rescue.

Recom Managed Systems (Los Angeles, California) said that a 510(k) premarket notification for the Recom Wireless EKG System has been submitted to the FDA. Recom's plans to market its initial device, a wireless electrocardiograph system (EKG), for widespread use initially by cardiologists for cardiac monitoring during stress tests as well as other in-office procedures which continue to prove challenging for physicians attempting to diagnosis a patient's cardiac state of health. The second intended use for the Recom wireless EKG system is the real-time continuous monitoring of a patient's EKG in ambulatory settings outside of the physician/clinical setting.

Ventracor (Sydney, Australia) said it has been issued two new patents. U.S. patent No. 6,609,883, titled "Rotary Pump with Hydrodynamically Suspended Impeller," includes features not previously claimed in earlier patents for its VentrAssist left ventricular assist system. The new U.S. patent relates to a hydrodynamically suspended impeller within a pump housing. In Australia, Ventracor has been granted Australian patent No. 760610, titled "A Rotary Blood Pump and Control System," by IPAustralia. The patent describes improvements to the VentrAssist and claims a new controller system specifically designed to work with VentrAssist.

VNUS Medical Technologies (San Jose, Califoria) reported the introduction of a new radiofrequency delivery device, Closure PLUS, for the treatment of saphenous vein reflux. The Closure System has previously been shown in multiple randomized trials to offer advantages over traditional vein stripping. With the Closure PLUS catheter, physicians can take advantage of an improved ergonomic design for greater ease of use during the procedure, and no longer need to sterilize and inventory instrument cables for the system.

World Heart (Ottawa, Ontario) said Health Canada has approved its submission to incorporate enhancements to its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients' quality of life by having a quieter device and smaller, lighter, longer-lasting battery packs. These enhancements are commercially available in Europe and under review for approval in the U.S. by the FDA.