Medtronic (Minneapolis) reported early last month its receipt of the CE mark for its Endeavor Drug-Eluting Coronary Stent with Rapid Exchange Delivery System and said it planned to launch the drug-eluting stent (DES) system simultaneously in 40 countries, outside the U.S. The Endeavor system – which Medtronic bills as the first cobalt alloy platform on the DES market – features “best-in-class deliverability, excellent clinical results and a strong patient safety profile,” according to the company
Dr. Jean Fajadet, MD, Clinique Pasteur Unite de Cardiologie Interventionnelle (Toulouse, France), a co-principal investigator of the ENDEAVOR II pivotal trial, said, “The results from the ENDEAVOR trials to date have been both comprehensive and positive. I have had experience with each of the drug-coated stents on the market, and I believe that physicians in the European Union and elsewhere around the world will find that Endeavor represents an excellent course of treatment for their patients.”
Medtronic reported strong clinical results in the ENDEAVOR II clinical trial, including a 47% reduction in Target Vessel Failure (TVF), the study’s primary endpoint, between the Endeavor arm and the control group. It also demonstrated a 62% reduction in target lesion revascularization (TLR). Safety data from the ENDEAVOR II study indicated a 50% reduction in the major adverse cardiac event (MACE) rate, compared to a conventional bare-metal stent, and just a 0.5% rate of stent thrombosis at 30 days – with no late thrombosis beyond 30 days and no late stent malapposition.
Medtronic said it would report results of the ENDEAVOR III trial at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington in October, and it noted that a fourth trial, ENDEAVOR IV, also is under way. The four trials will provide data on more than 2,000 Endeavor patients and will complete the information needed for submission to the FDA, the company said.
The Endeavor DES system combines the Driver bare-metal stent with a sirolimus-analogue drug, known as ABT-578, and a biocompatible polymer, called PC Technology, to treat coronary artery disease. ABT-578 is a compound licensed to Medtronic by Abbott Laboratories (Abbott Park, Illinois) and designed to inhibit the cellular process leading to restenosis. Medtronic also licenses Abbott’s phosphorylcholine polymer coating technology (PC Technology), licensed under patents owned by Biocompatibles (Oxford, UK).
AGA gets Japanese OK
AGA Medical (Golden Valley, Minnesota) has received approval from Japan’s Ministry of Health, Labor and Welfare to sell its Amplatzer Septal Occluder in that country. It is the first transcatheter occlusion device granted regulatory approval in Japan for treatment of atrial septal defect (ASD), a common and potentially fatal congenital heart defect. AGA Medical said that until the Amplatzer approval, open-heart surgery was the only treatment option in Japan for closing ASD. It said the Amplatzer Septal Occluder offers Japanese physicians and their patients “a less-invasive alternative to cardiac surgery for occluding, or closing, ASD.” The Amplazter device is marketed in more than 90 countries.
Franck Gougeon, AGA Medical’s CEO, said the Amplatzer device has proven “extremely safe and effective throughout nearly a decade of clinical experience internationally. We are pleased to bring this minimally invasive treatment option to Japan, where we believe physicians and patients will find it a welcome alternative to the rigors and recovery time associated with cardiac surgery.”
Most commonly diagnosed in infants and children, ASD allows increased blood flow into the heart’s right side, forcing it to work harder than normal. AGA said that in some cases, the defect is relatively small and closes naturally over time. “When the defect is larger or fails to close,” the company said, “patients can become easily fatigued have difficulty breathing, fail to grow normally, and be susceptible to colds, pneumonia and other infectious diseases. Left untreated, ASD can lead to heart arrhythmias, heart failure, high blood pressure, stroke, even death.”
As opposed to open-heart procedures, which can take four to seven hours or more, typical implantation with the Amplatzer is a one- to two-hour procedure. And the patient usually leaves the hospital within 24 hours and resumes normal activity soon thereafter, compared to the typical three- to five-day hospital stay and lengthy post-operative recovery with traditional surgery.
Biosite launches rapid Triage Stroke Panel
Biosite (San Diego) reported commercialization of its Triage Stroke Panel, a rapid immunoassay used to aid in the assessment and diagnosis of stroke, in the European Union, with registration pending in other international markets.
The test uses a small sample of blood to simultaneously measure four biomarkers: brain natriuretic peptide, D-dimer, MMP-9 and S100 beta. It is the first commercialized test to incorporate the company’s MultiMarker Index feature, which analyzes information from multiple biomarkers and presents a single composite index result.
“With the European launch of the Triage Stroke Panel, Biosite takes an important step forward in providing the European medical community with a diagnostic tool to help physicians identify patients who should be on the stroke care pathway,” said Kim Blickenstaff, chairman and CEO. “The incidence of stroke is on the rise and the lack of readily available diagnostic tools is evident.” Blickenstaff added that the test is designed to add “important objective information to the physician’s assessment of a patient presenting with symptoms of stroke.”
ProRhythm receives CE mark
ProRhythm (Ronkonkoma, New York), a manufacturer of devices for the treatment of atrial fibrillation (AF), said it has received the CE mark for its High Intensity Focused Ultrasound (HIFU) Ablation System for the treatment of AF, allowing the marketing of the system throughout the European Union. The HIFU system will be marketed through ProRhythm’s exclusive distributor for Europe, SJM International, a subsidiary of St. Jude Medical (St. Paul, Minnesota)..
Reinhard Warnking, ProRhythm president and CEO, said, “We have long been convinced that HIFU is the ideal energy for the treatment of atrial fibrillation. Our HIFU technology, along with St. Jude Medical’s strong sales and distribution capabilities, provide us with the potential to establish HIFU as the standard of care for catheter-based treatment of atrial fibrillation.”
ProRhythm’s balloon catheter to treat tissue in the left atrium of the heart is used in an AF ablation procedure called pulmonary vein isolation. The HIFU balloon is inserted through a vein in the leg of the patient and advanced into the left atrium. Discrete ablation lesions around the pulmonary veins, created with the HIFU catheter and controlled by the company’s automated system, stop unwanted electrical impulses from disrupting the heart’s normal rhythm.
The company said that unlike other energy forms used for this procedure, HIFU energy is non-thrombogenic and is focused in order to create transmural lesions within the myocardium. It said European clinical trials have demonstrated that a “significant percentage” of patients undergoing the HIFU ablation procedure have experienced a complete elimination of AF episodes with a single treatment procedure.
Companies in INR testing agreement
In other news involving St. Jude, the company has signed an exclusive agreement with HemoSense (San Jose, California) in most European countries to increase awareness and access to self-testing and monitoring the effectiveness of anticoagulation medication or Coumadin (warfarin) for mechanical heart valve patients. St. Jude is a leader in mechanical heart valve technology, having recently implanted its 1.5 millionth mechanical valve.
Under the agreement, the companies will develop joint promotional materials, including physician/ nurse educational information and patient education programs for physician-directed patient self-testing of anticoagulation therapy. They also will sponsor medical symposia and meetings.
Mechanical heart valve patients take blood-thinning medication to minimize the risk of thrombolic events and, as a result, regularly monitor their anticoagulation levels, a measurement expressed in Inter-national Normalized Ratio (INR). HemoSense’s handheld INRatio Prothrombin Time (PT) Monitoring System tests PT/INR levels in patients who are taking warfarin, a blood-thinning drug. The St. Jude Medical/HemoSense co-promotion alliance offers a self-testing solution for heart valve patients on anticoagulation therapy.
The INRatio PT monitoring system allows patients to self-test their anticoagulation levels at home rather than visiting a clinic or a laboratory. The companies said studies have demonstrated that patients who self-test on a regular schedule have fewer anticoagulation-related complications and stay within their therapeutic range more frequently than patients who do not self-test.
Denis Gestin, president of St. Jude Medical Europe, Middle East, Africa and Canada, said, “INRatio offers our heart valve patients a convenient PT/INR testing solution, whether they are testing at home or at their healthcare provider facility.” Jim Merselis, president and CEO of HemoSense, termed the INRatio monitoring system “a natural fit for St. Jude’s mechanical heart valves.”
In the U.S., St. Jude Medical has formed an alliance with Raytel Cardiac Services (Windsor, Connecticut), a wholly owned subsidiary of SHL-Telemedicine Ltd. (Tel Aviv, Israel), to promote the benefits of anticoagulation patient self-testing for mechanical heart valve recipients. Raytel’s system for remote INR self-testing is called INR@Home.
Terumo completes European clinical trial
Terumo Heart (Ann Arbor, Michigan) reported that the 20th patient was successfully implanted with its DuraHeart left ventricular assist system (LVAS) on July 19 at the University of Vienna General Hospital (Vienna, Austria), completing the European clinical trial of the device. The company said the clinical trial has been very successful in demonstrating the safety and performance of the DuraHeart in the treatment of end-stage left ventricular failure.
The DuraHeart is a third-generation circulatory support device. To date, five patients have been supported for more than six months, two patients more than one year, and one patient more than 16 months. Terumo Heart said it anticipates receiving the CE mark for the system early next year.