Guidant (Indianapolis, Indiana) reported the European market release of the next generation in pacemaker devices – the Pulsar MAX II blended-sensor pacemaker system and the Discovery II single-sensor system. "The Pulsar MAX II and Discovery II devices provide the world's first pacemaker systems with a unique combination of features to manage abnormal heart rates in the heart's upper chambers and provide unmatched stored electrogram quality," said Jay Graf, president of Guidant's Cardiac Rhythm Management Group. "We believe it provides solutions never before available to physicians faced with the challenge of treating pacemaker patients who also have atrial fibrillation."

The two devices introduce new features designed to help physicians manage patients with atrial arrhythmias by stabilizing the primary pumping action of the heart during periods of atrial fibrillation; minimize symptoms associated with atrial fibrillation or flutter; and prevent a sudden drop in a patient's heart rate.

The Pulsar MAX II also features a sophisticated algorithm designed to provide an appropriate heart rate for a patient's given level of activity. The device's proprietary blended sensor capability is designed to measure patient motion and a patient's respiration rate to optimize device therapy. The Pulsar MAX II and Discovery II devices include features that allow the clinician to easily and quickly perform a comprehensive set of automatic tests and follow-up operations. The result is one report that summarizes data needed for patient management.

Guidant also reported receiving FDA clearance to market its ACS Multilink RX Tristar and ACS Multilink OTW Tristar coronary stent systems, already sold in Europe and accounting for 75% of the firm's European stent sales. The Tristar system is indicated for use in first-time blockages and restenotic, or recurring, lesions in native coronary arteries. It is pre-mounted and balloon-expandable and available on both rapid-exchange and over-the-wire platforms.

Elsewhere in the product pipeline:

Abiomed (Danvers, Massachusetts) has received FDA approval of its PMA supplement covering an additional arterial cannula, or cardiovascular connector, to be used with the company's BVS-5000 bi-ventricular assist device. The BVS can temporarily take over the full pumping function of the heart to support patients with potentially reversible heart failure, allowing their failing hearts the opportunity to rest, heal and fully recover. The cannula is surgically attached to a heart's ascending aorta or pulmonary artery during implantation of the BVS. Comprised partially of a Hemashield graft, the cannula is smaller than prior BVS cannulae to allow maintenance of proper blood flow. The BVS is now available in more than 80% of all major medical centers that perform over 500 heart surgeries annually.

Acuson's (Mountain View, California) AcuNav diagnostic ultrasound catheter has received 510(k) clearance. The product, the result of a collaboration between the company and cardiologists at the Mayo Clinic (Rochester, Minnesota), provides better visualization of the heart during diagnostic and therapeutic procedures. "This device enables us to clearly see areas of anatomy that govern heart function we had not been able to visualize previously," said James Seward, a Mayo Clinic cardiologist, director of its echocardiography laboratory and one of the inventors of the AcuNav. "This catheter with the eyes of ultrasound allows for more precise imaging within the heart and blood vessels."

Alexion Pharmaceuticals (New Haven, Connecticut) said Phase I/II and IIa studies published in Circulation showed patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) who received a single dose of the complement inhibitor 5G1.1-SC had significant reductions in cardiac damage, new cognitive deficits and blood loss. Alexion and Procter & Gamble (Cincinnati, Ohio) are running a 1,000-patient Phase IIb study in patients undergoing CPB, and are initiating two additional 1,000-patient Phase II trials in heart attack patients.

Avant Immunotherapeutics (Needham, Massachusetts) said it completed enrollment in an open-label, Phase II trial of its lead investigational drug, the complement inhibitor TP10, in 15 infants (under 12 months) undergoing cardiac surgery requiring cardiopulmonary bypass. The study, being conducted at Duke University Medical Center (Durham, North Carolina) and the Cleveland Clinic Foundation (Cleveland, Ohio), will evaluate the safety of TP10 and its potential to reduce the consequences of reperfusion injury and to improve postoperative outcomes in these infants. About 15,000 infants in the U.S. undergo cardiac surgery to correct congenital heart defects each year.

Biovail International (Mississauga, Ontario, Canada) has received approval from the FDA for its generic version of Cardizem CD, which is indicated for the treatment of hypertension and angina. Teva Pharmaceuticals USA (Sellersville, Pennsylvania), Biovail's marketing partner, will launch the product immediately in all dosage strengths.

CryoLife (Kennesaw, Georgia), a developer of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, has submitted an FDA investigational device exemption supplement to expand a clinical study of its BioGlue surgical adhesive. The supplement requests an expansion to include using BioGlue in vascular and certain cardiac repairs, in addition to the commercially approved usage as an adjunct to the original application for acute thoracic aortic dissections approved in December. Shipments of BioGlue to U.S. hospitals began Jan. 3.

Hemosol (Toronto, Canada) reported completing U.S. Phase II cardiac bypass study of Hemolink, its first hemoglobin replacement product, or blood substitute, and that the results were positive. Closed this past November, the trial was conducted in nine U.S. centers, following 60 patients undergoing coronary artery bypass grafting (CABG) surgery. Results demonstrated Hemolink as safe in this patient population, and there were no clinically limiting side effects, according to the company's report. Also, study patients who received 750 ml of Hemolink required significantly less donor blood than patients in the control arm. Hemosol said the results are consistent with previously reported Phase II results from a similar study conducted at seven sites in Canada and the U.K., completed early in 1999. The company also said that the pivotal Phase III CABG trial in Canada and the U.K. is continuing to enroll patients.

IntraTherapeutics (St. Paul, Minnesota) reported receiving approval from the Japan Ministry of Health and Welfare to begin sales of its IntraStent Biliary Endoprosthesis, used to eliminate blockages in patients with obstructed bile ducts. The device is made of stainless steel and is balloon expandable. The IntraStent is cleared in the U.S. for biliary use and has the European CE Mark for renal, iliac and subclavian artery stenting. It is the first of IntraTherapeutics' products to be approved in Japan and will be sold through Getz Bros., a distributor of specialty medical devices. IntraTherapeutics manufactures and markets devices for the treatment of peripheral vascular disease and nonvascular obstructions.

Medtronic (Minneapolis, Minnesota) has introduced the Octopus 2+ tissue stabilization system, which incorporates improvements in its predecessor, the Octopus 2, designed to further reduce tissue motion and improve multivessel access during beating-heart surgery. The Octopus tissue stabilization systems employ suction to gently lift and hold the surface of a beating heart almost motionless while grafted vessels are sutured into place. The 2+ system features a four-cup pod stabilizer design and a stronger articulating arm that permits the stabilizer pods to be positioned along various cardiac arteries. It also allows a more controlled spread of the stabilizer pods to optimize exposure of the grafting site.

The first two brain aneurysm procedures in the U.S. using the Onyx Liquid Embolic System (LES) from Micro Therapeutics (MTI; Irvine, California) have been performed at Methodist Hospital (Houston, Texas) by Dr. Michel Mawad, chief of neuroradiology. George Wallace, MTI president and CEO, said, "We believe the Onyx LES system holds great promise as a new treatment option for potential stroke victims such as patients with brain aneurysms, representing what we believe to be a significant market opportunity." The Methodist Hospital procedures kick off the U.S. feasibility trial of Onyx LES for the treatment of brain aneurysms, adding to data gathered from 15 procedures performed in Europe and the Middle East. Feasibility trials in Europe began in September 1999 under the leadership of Dr. Jacques Moret, director of neuroradiology at Foundation Rothschild (Paris). Pending regulatory and clearances, Micro Therapeutics plans to expand to multicenter clinical trials in Europe and the U.S. The Onyx liquid embolic material is delivered through Micro Therapeutics' access and delivery devices, including the Rebar and EasyRider micro catheters, Flow Rider flow-directed catheter, Equinox occlusion balloon system and SilverSpeed guidewires. Once delivered to a vascular abnormality, the company said, "the Onyx liquid quickly transforms into a solid, yet flexible, polymer mass, completely and permanently sealing off the defective portion of the vessel. This enables full blood flow to resume through the parent vessel with less risk of rupture and subsequent stroke."

North American Scientific (Chatsworth, California) and Theseus Imaging (Cambridge, Massachusetts) reported that Theseus has achieved a significant technical milestone in clinical studies of its Apomate Kit for use in imaging apoptosis associated with organ transplant rejection. The company successfully correlated noninvasive imaging of apoptosis with biopsy-proven cardiac transplant rejection using Theseus' Apomate Kit for the preparation of Technetium Tc-99m recombinant human Annexin V. Nuclear medicine images obtained using routine instrumentation available in over 3,500 U.S. hospitals demonstrated localization of the imaging agent in patients with transplant rejection. In current clinical practice, obtaining such information requires repeated cardiac catheterization and endomyocardial biopsy. Apomate is intended to provide equivalent information through a noninvasive imaging procedure using a new technique involving molecular imaging of the biochemical changes associated with rejection.

Pharmanetics (Raleigh, North Carolina), the holding company of Cardiovascular Diagnostics, said the FDA had cleared the company's Accent system and Heparin Management Panel for U.S. marketing. The system combines the company's Thrombolytic Assessment System (TAS) technology and the currently marketed Heparin Management Panel with two new test cards – the Heparin Titraton Test and Protamine Response Test – along with the Accent, an accessory to the TAS analyzer. A microprocessor-based device, the Accent calculates the information required by physicians to manage the anticoagulation of patients during cardiopulmonary bypass. The TAS is marketed as Rapidpoint Coag by Bayer Diagnostics, which also will market the Herparin Management Panel and Accent system as Rapidpoint Accent, with a 2Q00 launch anticipated.

The FDA has granted to Polymer Technology Systems (Indianapolis, Indiana) conditional approval to begin investigational testing of its implantable device for testing of body fluid collected subcutaneously. It combines a device called the Capillary Filtrate Collector (CFC) and an electro-mechanical device called the Filtrate BioScanner that measures glucose levels in the ultrafiltrate collected via the CFC. Initial clinical studies will be performed on diabetic surgical patients by following the patient with correlating fingerstick glucose in the operating room, and then for two hours in post-operative settings.

Spectranetics (Colorado Springs, Colorado) has received FDA 510(k) clearance to market a new product for interventional cardiovascular therapy, the Spectranetics Support Catheter. The catheter is designed for use in the cardiovascular system for accessing and/or crossing lesions. The primary function is to support an angioplasty guidewire. The Support Catheter complements Spectranetics' other one-time-use products for interventional cardiovascular therapy, and the company calls it is a high-margin product in a market estimated at 30,000 procedures annually.

St. Jude Medical (St. Paul, Minnesota) reported the first implants of the Photon DR implantable cardioverter defibrillator (ICD) with dual-chamber pacing capabilities. Malte Meesman, MD, of the Medizinische Universitatsklinik (Wurzberg, Germany), implanted the ICD device Dec. 21 in a 57-year-old female patient who had survived an episode of sudden cardiac death. And Jorg Neuzner, MD, of the Kerckhoff-Klinik (Bad Nauheim, Germany), implanted the second device Dec. 23 in a 58-year-old male patient with syncope and VT. The company also said it is launching a new cardiac pacing lead in the European market that St. Jude calls "the thinnest of its type in the world." The Tendril SDX lead employs an extendable-retractable helix for active fixation in either the atrium or the ventricle. It also incorporates a steroid-eluting tip that reduces inflammation and pacing thresholds. Its small diameter facilitates implantation to reduce operative time and surgical trauma.

Vital Signs (Totowa, New Jersey) introduced two new products at the recent American Association of Respiratory Care national conference: the Pocket Blue, a first-responder resuscitator, and the Aspirator Plus arterial blood gas syringe. The Aspirator Plus is designed to keep air contamination out of the arterial blood sample through a filter that separates air behind the blood. The Pocket Blue is intended to provide more protection to the responder and victim during the resuscitation phase of CPR. Vital Signs and its subsidiaries design, manufacture and market single-use medical products for anesthesia and critical care. Its products have received the CE Mark and ISO 9001 certification.