In what constitutes a new phase in the development of its technology for the heart assist market, Thoratec (Pleasanton, California) last month reported the start of its Phase I safety trial for its HeartMate II axial-flow left ventricular assist device. The HeartMate II, intended for long-term support for patients who are in end-stage heart failure, was implanted in an 18-year-old male at the Texas Heart Institute (Houston, Texas) by Bud Frazier, MD, chief of cardiopulmonary transplantation and director of surgical research at the institute, and chief of the transplant service at St. Luke's Episcopal Hospital (also Houston).

Keith Grossman, president and chief executive officer, called the first implantation "a major clinical milestone" for Thoratec, since its other heart assist devices have been of the pulsatile variety that is, having mechanics that create a pulse-like beat and the HeartMate II is the first axial-flow device the company has put into clinical trials.

The trial calls for enrollment of seven patients at three other sites besides the Texas Heart Institute Columbia Medical Center (New York); Latter Day Saints Hospital (Salt Lake City); and the University of Pittsburgh Medical Center (Pittsburgh, Pennsylvania), where some of the components of the Heartmate were developed in its early R&D stages. Thoratec had hoped to have all seven patients enrolled by the end of the year, Grossman told Cardiovascular Device Update, but he said that a more realistic timeline now is for enrollment completion by the end of 1Q04. The Phase I trial is to determine safety, with the patients evaluated at the end of 30 days after implant "to make sure the pumps are able to be implanted properly and appropriately, with no adverse events, and that they are capable of hemodynamically supporting the patients," he said.

Grossman said that by the end of the first quarter, the company hopes to have developed enough data to begin plans for a Phase II pivotal trial of the Heartmate II, adding that there are still "open questions" about what that trial will look like.

Because it operates with a rotary pump, the HeartMate II LVAS is significantly smaller than pulsatile devices, and so can be used in smaller individuals. It weighs about 12 ounces and is about 1.5 inches in diameter and 2.5 inches in length. It has only one moving part and thus can be made to be simpler and quieter than pulsatile systems. Thoratec said that a key unique feature of the device is its automated speed control mode, which "is designed to regulate pumping activity based on different levels of patient or cardiac activity." It added that other devices currently in clinical evaluation must be manually adjusted.

Frazier called the implantation in the Houston patient "flawless" and the technology "without complications." He said that the patient was soon out of the intensive care unit and ambulatory "which is pivotal, considering how near death he was." He said the HeartMate II "is an important advance for all end-stage heart failure patients, especially for the smaller patients who are currently not supportable by the larger pump technology."

The company also has in development a second non-pulsatile pump, the HeartMate III, which instead of using axial flow employs a "centrifugal flow" non-pulsatile approach, Grossman said. That pump is in preclinical evaluation. He said that both the Heartmate II and Heartmate III are designed to accommodate bridge-to-heart transplant and destination therapy patients. However, Grossman noted that clinical trials serve to identify the benefits and weaknesses of products, so more work needs to be done to identify what kinds of specific applications will be sought from the FDA.

While the Heartmate II and III devices are in development, he said Thoratec's HeartMate XVE pulsatile device was described by Grossman as likely to continue as the company's "workhorse" for both bridge to transplant and destination therapy. He said that while rotary pumps "will absolutely play a role" in the heart assist device sector, "they will not completely replace pulsatile devices." Rotary devices will provide "a nice complement we'll just have to see how big that complement is."

Elsewhere in the product pipeline:

Alsius (Irvine, California), has received 510(k) clearance from the FDA to market its ICY and Fortius catheters in combination with the company's CoolGard 3000 Thermal Regulation System. The products are indicated for use in cardiac surgery to achieve and/or maintain normothermia during surgery and recovery/intensive care, and in neurosurgery to induce, maintain and reverse mild hypothermia in surgery and recovery/intensive care. The catheters feature heat exchange balloons in which cool or warm sterile saline continuously flows in a closed-loop fashion and the CoolGard system remotely senses changes in patient temperature and adjusts the temperature of the sterile saline flowing within the balloons as needed. The effects of anesthesia and cool temperatures in the operating room during cardiac surgery often create an undesired drop in patient temperature. Shivering places additional strain on already damaged heart muscle and has shown to have a negative impact on a patient's length of stay in the hospital. And patients routinely are cooled three or four degrees below normal temperatures during neurosurgical repair of aneurysms to protect the brain tissue during the operation. The cooling is followed by actively rewarming the patient back to normal temperature at the end of the procedure to prevent post-operative complications.

Biotronik (Lake Oswego, Oregon) reported the first U.S. implantation of an implantable cardioverter defibrillator (ICD) that provides three essential therapies in a single device: cardiac resynchronization therapy (CRT) for treating heart failure, atrial therapy for atrial tachyarrhythmias, and ICD therapy for ventricular tachyarrhythmias. Dr. Kyong Turk performed the first implantation of the system at Nebraska Heart Institute (Lincoln, Nebraska), in an 84-year-old patient with advanced heart failure. Turk said, "If an implantable device can reduce AF burden, we can obtain more benefit from CRT. The Biotronik Tupos LV/ATx is a novel device that provides a range of therapies to treat a variety of cardiac disorders. As a result, the implanted device becomes a more cost-effective form of therapy." The patient was enrolled in Biotronik's latest investigational study aimed at evaluating the benefits of these combined therapies. The initial study will compare the clinical benefits of CRT in patients implanted with the Biotrnoik device to the benefits of CRT in patients implanted with CRT-ICDs from Guidant (Indianapolis, Indiana) and Medtronic (Minneapolis, Minnesota), without atrial therapy.

CardioTech International (Woburn, Massachusetts) said it entered Phase II trials for its CardioPass coronary artery bypass graft following the mid-October implantation of the graft during a triple bypass procedure on a 76-year-old woman at the Institute for Cardiology (Porto Alegre, Brazil). Michael Szycher, chief executive officer, said, "With this third implantation, we are freezing the 'Nesralla' protocol and entering Phase II." Phase II trials will involve an additional 10 clinical centers in Brazil and Chile. CardioTech's vascular grafts are made of ChronoFlex, a family of polyurethanes the company said has been demonstrated to be biodurable and biocompatible.

EP MedSystems (West Berlin, New Jersey) said its Alert Companion II has 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 (AF) or a lifelong regimen of antiarrhythmic drugs. We used the Alert system, which easily cardioverted the patient back into normal sinus rhythm." The system delivers programmable low-energy, biphasic electrical impulses directly to the inside of a patient's heart to convert atrial fibrillation to a normal rhythm. The electrical impulses are delivered via a specially designed catheter used in tandem with the Alert Companion energy source.

Guidant (Indianapolis, Indiana) reported FDA approval of the Endotak Reliance G family of defibrillation leads. The product line features a proprietary covering to prevent tissue in-growth into the defibrillation coils without compromising the electrical performance of the lead. The Endotak Reliance G leads feature a covering from W.L. Gore & Associates (Flagstaff, Arizona) through an exclusive agreement between the companies. Guidant said it is the first defibrillation lead on the market to address tissue in-growth using this approach. Separately, Guidant reported FDA approval of the latest addition to the Insignia family of pacemakers the Insignia Ultra, designed for treatment of bradycardia. The new pacemaker includes automatic capture, which looks at every beat to see if the lower chambers of the heart contracted in response to the delivered pacing pulse from the device. If no contraction is detected, a backup pace with more energy is issued to ensure contraction. The AutoLifestyle feature is designed to automatically tailor Guidant's blended sensor technology to each patient by approximating a normal heart response for people who can't do so on their own.

Medtronic (Minneapolis, Minnesota) reported the start of patient enrollment in its VALOR (Evaluation of the Safety and Efficacy of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) study. The prospective, non-randomized, consecutive trial will be conducted at 35 clinical sites throughout the U.S., involving about 500 patients, and will study the use of the investigational Talent Thoracic Stent Graft System in three distinct groups of patients with disease of or trauma to the thoracic aorta.

St. Jude Medical (St. Paul, Minnesota) reported the launch of the Angio-Seal Millennium Platform vascular closure device for sale in Japan. Joseph McCullough, president of St. Jude Medical International, said, "The impressive clinical and patient benefits provided by the Angio-Seal closure device will enable Japanese clinicians to significantly improve lab efficiencies and patient comfort." In addition, St. Jude Medical Canada (Mississauga, Ontario) said that on Nov.14, Dr. Tirone David successfully implanted the 20,000th Toronto Stentless Porcine Heart Valve (Toronto SPV valve) at Toronto General Hospital (Toronto, Ontario), marking a milestone for both the device and for David, who invented it.

Zoll Medical (Chelmsford, Massachusetts) unveiled two new emergency medical services (EMS) products at MEDICA, in Dusseldorf, Germany, last month. The Bluetooth wireless option for the Zoll M Series defibrillators offers both real-time digital transmission of 12-lead electrocardiogram and vital signs information. The ResQPOD Circulatory Enhancer for Cardiac Arrest significantly increases blood flow to the heart and brain during CPR. The company also commented on a study abstract released in November on the performance of the Zoll Rectilinear Biphasic (RLB) waveform in the pre-hospital setting. The study abstract reported preliminary results of a comparison of the Zoll RLB waveform with a conventional monophasic waveform. The ORBIT (Out of Hospital Rectilinear Biphasic Investigation and Trial) trial enrolled 4,532 cardiac arrest patients treated by the Metropolitan Toronto (Ontario) EMS Service. Interim results showed an improvement in shock success from 45% to 54% over the monophasic waveform.