St. Jude Medical (Minneapolis, Minnesota) reported receiving FDA approval and European CE marking, as well as the first implant of its Atlas Plus implantable cardioverter defibrillator (ICD), which it said is the highest-output (36 joules delivered/42 joules stored) rate-adaptive device on the market. High-energy outputs are particularly helpful for patients who have life-threatening high or rising defibrillation thresholds, the company said.

Competitor Medtronic (Minneapolis, Minnesota) received an approval last month for its own high-output ICD, the Maximo, which is built on the platform of its Marquis ICD and is capable of producing 35 joules of delivered energy.

Drs. Neal Lippman and Joseph Dell'Orfano performed the first implant of the new ICD at St. Francis Hospital (Hartford, Connecticut). The procedure went as expected and the patient, a 44-year-old male, is doing well. "It's impressive to find such high-energy output in a small, physiologically shaped ICD that is adaptable to numerous patient conditions with excellent therapeutic efficiency," Lippman said. And Dell'Orfano added, "The high-voltage lead integrity test and comprehensive summary screen expedite implantation by providing essential threshold and impedance data at a glance."

Michael Coyle, president of St. Jude's Cardiac Rhythm Management business, said, "In addition to being the world's most powerful rate-adaptive ICD, the Atlas Plus ICD provides advantages over conventional high-energy devices without compromising size or longevity." He added that the device includes "AF Suppression technology and AutoIntrinsic Conduction Search, giving physicians an opportunity to provide ICD therapy to a broad array of patients with complex co-morbidities and concomitant drug therapies."

Peter Gove, vice president of corporate relations at St. Jude, said, "Now we are adding AF Suppression to both the Epic and the Atlas, so the Atlas Plus is the Atlas plus the AF Suppression algorithm." The Epic is the company's top-of-the-line, smaller ICD and the Atlas its top-end, high-power ICD. "We've added AF Suppression, which prior to that had been in all of our pacemakers. We've now added [it] to our standard ICDs," he told CDU. Gove said the approval was a simple matter for U.S. regulators. "For the FDA, this is a supplement of software and hardware they previously approved, so there was no need for an investigational device exemption."

Aside from the algorithm, Atlas Plus ICDs incorporate a set of tachycardia and bradycardia features, including:

AutoIntrinsic Conduction Search (Positive AV/PV hysteresis) to promote the heart's natural AV synchrony and reduce unnecessary RV pacing that may exacerbate the onset of heart failure, as shown in the landmark DAVID (Dual-Chamber and VVI Implantable Defibrillator) clinical trial.

Programmable waveforms and shocking vectors to give physicians greater flexibility to address individual patient needs for life-saving cardioversion and defibrillation therapy, which may eliminate the need for additional surgical procedures.

Auto Sensitivity Control, designed to eliminate oversensing without adjusting maximum sensitivity levels, which can compromise the device's ability to detect dangerous low-amplitude fibrillation.

AV Rate Branch (dual-chamber model only) and Morphology Discrimination to help reduce the risk of inappropriate shocks while promoting fast diagnosis and delivery of therapy.

"The next step you will see from us is we will announce that the Atlas HF [heart failure] device is available in Europe," Gove said. While he acknowledged that St. Jude still trails its competitors in the promising cardiac resynchronization therapy market in the U.S., "I think everyone is expecting us to be in the U.S. heart failure market by NASPE [the North American Society of Pacing and Electrophysiology] of next year, and that's been our guidance to the financial community."

The FDA initially approved St. Jude's Atlas family of ICDs in January 2002.

Elsewhere in the product pipeline:

Acorn Cardiovascular (St. Paul, Minnesota) reported completing enrollment in the Acorn pivotal randomized clinical trial of the CorCap Cardiac Support Device (CSD) used to treat heart failure (HF). The trial has enrolled 300 patients in 29 centers across North America, "making it the most extensive controlled evaluation of a surgical treatment for HF ever undertaken," Acorn said. CorCap CSD is a fabric mesh surgically positioned around the ventricles of the heart to provide passive support. Preclinical studies have shown that supporting the heart in this manner reduces wall stress, thereby stopping deterioration of the heart muscle and producing a reduction in heart size and improvement in heart function. It is anticipated that the CorCap CSD could provide relief of heart failure symptoms, improve quality of life and extend survival for those who suffer from HF. Primary criteria for participation in the Acorn pivotal trial were patients diagnosed with an enlarged heart in Class III or early Class IV heart failure, age 18 to 80, in stable condition and currently under medical management with beta-blockers and ACE inhibitors. Acorn said it is in the process of completing the required one-year follow up for all patients enrolled in the Acorn Pivotal Trial and anticipates submitting clinical trial data to the FDA in early 2005 with projected FDA approval in mid-2005.

AngioDynamics (Queensbury, New York) reported the release of the AquaLiner hydrophilic Ni-Ti alloy guidewire for sale in the U.S. The AquaLiner guidewire has a hydrophilic coating, which helps reduce friction when the guidewire comes into contact with fluids. This feature allows a physician to move the guidewire through vessels and catheters with greater ease, simplifying guidewire placement in endovascular procedures.

Angiotech Pharmaceuticals (Vancouver, British Columbia) reported starting enrollment in its first human peripheral bypass study that will evaluate a proprietary drug-loaded vascular wrap. The drug-loaded wrap is designed to prevent or reduce stenosis at the bypass attachment site. Patients diagnosed with peripheral vascular disease undergoing below-the-knee femoral-popliteal arterial bypass surgery will receive a traditional graft, or a graft plus Angiotech's paclitaxel-loaded, biodegradable vascular wrap. When applied to the outside wall of the vessel, the wrap delivers drug to the blood vessel wall in a targeted manner to prevent stenosis associated with bypass surgery. If successful, the drug-loaded vascular wrap could potentially be used in peripheral graft procedures to prolong the life of the bypass grafts and expand the possible application into the treatment of more difficult smaller vessels. The 60-patient, open-label randomized study is expected to include up to six sites in Europe as well as the Netherlands Antilles.

AusAm Biotechnologies (Santa Monica, California) said it has received the CE mark for the Microalbumin Plus, which aids in the detection of microalbuminuria in at-risk patients. The Microalbumin Plus is the first and only test that permits direct measurement of a protein called albumin in urine. The test increases the ability to measure some intact albumin in urine that is not detectable by commonly used urine tests, and reduces the potential for false negative results that may arise with other urine tests.

A study supported by Bayer Biolog

ical Products (Bayer BP; Research Triangle Park, North Carolina) reported that albumin, used as a blood volume expander in coronary artery bypass graft (CABG) surgery, is associated with a significantly lower incidence of mortality compared to non-protein expanders. Plasbumin-5 is Bayer BP's albumin product. The study of 19,578 patients published in the June issue of CHEST, the journal of the American College of Chest Physicians (Northbrook, Illinois), reported the mortality rate for patients given albumin during CABG surgery was 25% lower than for those receiving other types of blood volume expanders, specifically non-protein colloids (hetastarch [6% hydroxyethyl starch] or dextran). As a result, use of albumin was found to save five to six additional lives per 1,000 patients. Albumin therapy also was shown to be a cost-effective alternative to other blood volume expanders. The study was conducted by researchers at Yale University (New Haven, Connecticut).

Beckman Coulter (Fullerton, California) has begun shipping the new Coulter LH 500 hematology analyzer. Designed for mid- to high-volume clinical laboratories, the LH 500 provides complete blood counts with five-part differential analysis, including white blood cell, red blood cell, platelet and reticulocyte counts. The analyzer is designed for mid- to high-volume customers and offers a wide linearity range for white blood cells and platelets that is comparable to the company's LH 750 hematology analyzer.

Cardima (Fremont, California) said Didier Loulmet, MD, chief of the minimally invasive robotic cardiac surgery program at Lenox Hill Hospital (New York), provided the first case reports on four cases using the Cardima Surgical Ablation System to treat atrial fibrillation (AF). Loulmet presented his cases at a two-day educational program sponsored by Cedars- Sinai Heart Center in Santa Monica, California. According to Loulmet, all four cases he has completed so far have had a consistent pattern of response. "We have been impressed with the visual consistency and clarity of the thin lesion pattern created and with the remarkable consistency of the clinical outcome of those patients treated," he said. "Although our experience base is small, Cardima's system has provided us with consistent results on a category of patients that are very difficult to treat. These patients were in chronic AF ranging from eight to 15 years. All four patients remain in normal sinus rhythm without the aid of drug therapy."

CardioTech International (Woburn, Massachusetts) said it is expanding the number of hospitals and clinical investigators participating in the feasibility phase of its clinical trial for its CardioPass Coronary Artery Bypass Graft. Ten surgeons in Brazil and Chile have agreed to participate in CardioTech's ongoing trial, pending ethical committee approval, representing 10 additional hospitals. CardioTech said it intends to implant a maximum of 20 patients with the graft in the feasibility trial.

Cholestech (Hayward, California) said that the FDA has granted 510(k) clearance for the company's new liver function test, Aspartate Aminotransferase (AST). AST quantitative measurements are used by physicians in the diagnosis and treatment of certain liver diseases and heart diseases.

Cordis (Miami Lakes, Florida) said that final results from the second major European clinical study of the Cypher Sirolimus-eluting coronary stent, published in The Lancet, highlight the significance of the technology, which it said continues to confirm that treatment with the Cypher stent results in sustained improvement in reducing coronary reblockage during clinical follow-up compared to a conventional bare- metal stent. The Lancet article cites findings from clinical investigators of the E-SIRIUS trial, who discovered that patients treated with the Cypher stent maintained minimal vessel re-narrowing and concomitant suppression of neointimal hyperplasia, translating into an event-free survival rate of 92% at 270 days. This compares with a 77% event-free survival rate for patients treated with the conventional bare metal stent in the control arm of the study. The eight-month angiographic evaluation showed that 43.6% of all patients who received the conventional bare-metal stent exhibited reblockage. Within nine months, the rate of major adverse cardiac events also was significantly reduced in patients treated with the Cypher stent.

Edwards Lifesciences (Irvine, California) reported completion of a 16-year follow-up of the effectiveness and durability of its Carpentier-Edwards Perimount mitral pericardial heart valve. The data, compiled at seven centers in Europe and Canada, followed more than 430 patients. The report concluded that patients 60 years and older who received the valve, which includes biomechanically engineered bovine pericardial tissue, had a nearly 90% chance of not needing a new valve, due to structural valve deterioration, for 16 years. The company said the study also confirms the valve's safety through a low incidence of complications, such as bleeding and thromboembolism. Edwards recently introduced in the U.S. its ultra-low-profile Tricentrix holder, designed to offer better visualization and operating space for surgeons implanting the Perimount mitral valve.

Endocardial Solutions (St. Paul, Minnesota) reported the release of the next version of its EnSite NavX intracardiac, non-fluoroscopic navigation system. EnSite NavX, which was first released in May as an integrated part of the EnSite System, allows electrophysiologists to visualize and navigate a complement of intracardiac catheters in any chamber of the heart for diagnostic and therapeutic applications. EnSite NavX enables physicians to simultaneously display more electrodes and catheters than any other 3-D mapping system currently available, the company said.

EP MedSystems (West Berlin, New Jersey) has received premarket approval notification on its supplemental application from the FDA for the Alert Companion II, a biphasic defibrillator to be used as part of the catheter-based Alert Internal Cardioversion System to treat atrial fibrillation. The Companion II defibrillator improves upon the company's previously approved Companion I's performance and offers a significantly smaller footprint for the electrophysiology lab, it said. The Alert system uses internal cardioversion to treat atrial fibrillation, delivering programmable low-energy, bi-phasic electrical impulses directly to the inside of a patient's heart to convert atrial fibrillation to a normal rhythm. EP Medsystems also reported that the Alert Companion II had been successfully used in its first routine internal cardioversion case in the U.S. Dr. James Higgins, a cardiologist practicing at Saint Francis Hospital (Tulsa, Oklahoma), said the ALERT system was used for a patient who had failed external biphasic cardioversion several times, "and was anticipating either chronic atrial fibrillaton or a lifelong regimen of antiarrhythmic drugs. We used the ALERT system, which easily cardioverted the patient back into normal sinus rhythm."

Guidant (Indianapolis, Indiana) reported receipt of the European CE mark and first implants of the newest addition to the Renewal family of cardiac resynchronization therapy defibrillators (CRT-D), the Contak Renewal 4. The combination pacemaker-defibrillator helps restore both chambers of the heart to a normal rhythm and guard against dangerously fast heartbeats. The company said the Renewal 4 represents its most advanced offering for treatment of congestive heart failure therapy, delivering what it termed "industry-leading therapies and diagnostics." The device is the thinnest CRT-D available on the market today, Guidant said, making it easier to implant and able to give added comfort to patients. The system uses independent sensing and independent electrical stimulation to deliver appropriate therapy to both the left and right ventricles. First implants of the Renewal 4 occurred at the Ospedale Civile di Asti (Asti, Italy), Ospedale Santa Chiara (Trento, Italy) and Klinikum der Friedrich-Schiller-Universitaet Jena (Jena, Germany). The Renewal 4 system is Guidant's fourth-generation CRT-D in Europe.

IDev Technologies (Houston, Texas) reported the commercial release of its CE-marked Texan foreign body retrieval device into the European market. The Texan was initially indicated for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system and hollow viscous. The device is guidewire-compatible and features a variable, radiopaque loop design, which allows for loop size adjustment during the procedure and within the vessel.

I-Flow (Lake Forest, California) reported that The Journal of American Society of Anesthesiologists has published a study of post-surgical pain relief following coronary artery bypass graft (CABG) surgery. The goal of the study was to establish safety and efficacy of the company's ON-Q Post-Operative Pain Relief System, a continuous local anesthetic delivery at the surgical site after CABG procedures. It was observed that patients left the hospital 1.5 days earlier, experienced a significant reduction of narcotic use during recovery and returned to their normal activities faster when ON-Q was used.

InforMedix (Rockville, Maryland) said that a study of patients with congestive heart failure has demonstrated that the Med-eMonitor, a web-based, compliance-monitoring device, significantly improved medication compliance and overall clinical-protocol adherence after the three-month study. The study, reported in the July/August issue of Heart & Lung, showed that elderly patients who were periodically prompted by the Med-eMonitor hand-held communications device were more apt to take prescribed medications on schedule a 94% medication-compliance rate as compared to a "usual care only" control group.

Medtronic (Minneapolis, Minnesota) reported commercial availability in Europe of the Cardioblate Bipolar (BP) Surgical Ablation System, designed to help surgeons treat atrial fibrillation. The Cardioblate BP System is the first irrigated bipolar surgical radio-frequency (RF) ablation system providing surgeons with a transmurality feedback mechanism that alerts them when an ablation line has been created through the full thickness of the tissue. During an irrigated RF surgical ablation procedure, the Cardioblate BP System's two electrodes can be used to create linear lesions in the atrium. The flexible, adjustable jaw mechanism allows the surgeon to easily place the 5 cm electrodes to isolate the errant signals that cause atrial fibrillation, while potentially avoiding cardio-pulmonary bypass. The irrigation cools the surface tissue during ablation, improving energy delivery to the tissue and facilitating the detection of a completed ablation line. The system also incorporates the Cardioblate Pen, enabling lesion pattern flexibility to meet individual patients' needs, Medtronic said.

Rubicon Medical (Salt Lake City, Utah) said it has successfully completed the first human cases of its Rubicon Filter in the carotid arteries. Rubicon's carotid studies are being conducted by Dr. Juachim Schofer, co-founder of the Center of Cardiology and Vascular Intervention (Hamburg, Germany) and principal investigator for the clinical studies seeking clearance for use of the Rubicon Filter in carotid arteries. The Rubicon Filter is designed for use in medical procedures downstream from a blockage in a bloodstream to allow the capture and removal of dislodged embolic material. It is a guidewire-based filter that is deployed without the use of a catheter, making it smaller and easier to navigate through blood vessels than other embolic protection devices. Rubicon said the filter's small profile should considerably decrease trauma to the body and the risk of dislodging particles during passage of the filter through a blockage in a blood vessel.

Tensys Medical (San Diego, California) said that anesthesiologists from Shands Hospital at the University of Florida (Gainesville, Florida) and the University of Colorado Health Sciences Center (Denver, Colorado) presented two studies comparing the accuracy of the traditional, invasive intra-arterial A-line with the Tensys T-Line, a non-invasive, continuous, real-time blood pressure monitor, at last month's American Society of Anesthesiologists annual meeting in San Francisco, California. Data from both studies demonstrated that T-Line had clinically equivalent accuracy to the A-line without the associated risks of invasive cannulation. In addition, the University of Florida's study showed that the T-Line required less time to acquire a real-time, high-fidelity waveform.