Replacement and repair of heart valves without opening the chest is one of the largest new opportunities in the cardiovascular space over the next five to 10 years years. And it is one that Medtronic (Minneapolis) is attempting to mine with a new interventional system designed to reduce the number of times certain patients with congenital heart disease may need open-heart surgery.
Medtronic last month reported the first implant procedure in the launch of a feasibility study of its Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System. The Melody valve and delivery system is used to treat patients requiring pulmonary heart valve replacement because of a congenital defect. The company said the valve is the first of its kind in North America.
The study, a prospective, non-randomized trial, will enroll 30 patients at three U.S. medical centers: at Children’s Hospital Boston (Boston) by investigators James Lock, MD, cardiologist-in-chief and Emile Bacha, MD, senior associate in cardiac surgery; Morgan Stanley Children’s Hospital of New York - Presbyterian by investigators William Hellenbrand, MD, director of catheterization laboratory for congenital heart disease and Ralph Mosca, MD, director of pediatric cardiac surgery; and Miami Children’s Hospital (Miami, Florida) by investigators Evan Zahn, MD, chief of cardiology, and Redmond Burke, MD, chief of cardiovascular surgery.
Jill Hennesen, a senior marketing development manager for Medtronic, told Cardiovascular Device Update that the Melody valve and Ensemble delivery system provides another choice for clinicians who are managing patients with congenital heart disease, not just following birth but throughout their lives.
“This is one more treatment option that the interventional cardiologist and cardiac surgeon — who are very closely collaborating in managing these patients — have when deciding what kind of treatment option is going to provide the most benefit to these patients,” she said.
Medtronic said this type of defect normally requires open-heart surgery early in life to implant a prosthetic or bioprosthetic valved-conduit to establish adequate blood flow from the heart to the lungs. But the functional life span of these conduits is relatively limited and, as a result, most patients with this type of defect may require multiple open heart surgeries to place new valved conduits as they grow over their lifetime.
Hennesen emphasized the importance of the cardiologist/cardiac surgeon cooperation in treating congenital heart disease because patients with this defect tend to be very sick and usually must face this series of surgeries. “It’s not uncommon for these patients to undergo surgery almost immediately after birth or as infants, depending on the situation,” Hennesen said.
Medtronic said it would use this trial to evaluate the Melody valve and Ensemble delivery system as a catheter-based alternative treatment in order to restore pulmonary valve function and prolong the functional life of the right ventricle to pulmonary artery conduits, thus hopefully reducing the need for later open-heart surgeries.
Lock, of Children’s Hospital Boston, said the implant procedure was conducted both “clinically and from a quality-of-life perspective for the patient.”
Medtronic has partnered with Philipp Bonhoeffer, professor and chief of cardiology and director of the Catheterization Laboratory of Great Ormond Street Hospital for Children (GOSH; London), and NuMed Canada (Cornwall, Ontario), a pediatric catheter company in the development of the Melody valve and Ensemble system.
A pioneer in transcatheter valve technology, Bonhoeffer implanted the world’s first transcatheter valve in September 2000. Medtronic said that, to date, more than 200 patients have been treated with the device worldwide.
Hennesen said the feasibility trial is Medtronic’s first step towards FDA approval of the device.
The company received Canadian product approval in January and CE-marking in September 2006 of the valve and delivery system.
Elsewhere in the product pipeline:
• AtriCure (West Chester, Ohio) reported that it has received FDA 510(k) clearance for its Isolator Synergy Bipolar Ablation System for the ablation of soft tissue. The device is not yet cleared for the ablation of cardiac tissue. The system incorporates two pulsing pairs of electrodes in the jaws of the clamp, which the company believes will allow physicians to ensure full thickness ablation of thicker and more diseased tissues and create more durable lines of block. Pre-clinical studies using the system have demonstrated that the lesions are shaped like columns for durability and that the ablation lines are consistently transmural in thicker tissues, which the company believes will result in superior patient outcomes. AtriCure makes surgical devices.
• Boston Scientific (Natick, Massachusetts) reported FDA 510(k) clearance to expand its PolarCath peripheral dilatation system offering to include a 100 mm balloon. The system is used to restore blood flow and reduce the risk of amputation in patients with critical limb ischemia (severe blockages in the arteries below the knee), or femoropopliteal blockage, a result of peripheral artery disease. The 100 mm balloon is available in both 0.014 inch and 0.035 inch diameters. The system also offers balloon lengths of 20, 40, 60 and 80 mm. Angioplasty therapy using the PolarCath cools the inside of occluded arteries in the legs while opening the blockages. This technology uses nitrous oxide to fill an angioplasty balloon within a blocked artery, cooling the balloon’s surface to -10 degrees C. As it is inflated, the cold surface of the balloon cools the vascular lesion, which may help prevent re-blockage of the artery.
• Cook Medical (Miami) reported that the Zilver PTX Paclitaxel-Eluting Stent (DES) trial results demonstrated no stent fractures. Cook said that the major adverse event rate was equivalent to conventional balloon angioplasty treatment at its six-month follow-up point. To reduce or prevent restenosis, the Zilver PTX stent is coated with Paclitaxel, a drug approved for clinical use as an anti-cancer agent. Paclitaxel-coated coronary stents are approved for use in the U.S. to reduce the risk of restenosis of the coronary arteries. Cook produces medical therapies in the fields of radiology, cardiology, urology, endovascular therapy, women’s health, critical care medicine, surgery and soft tissue repair, gastroenterology, bone access, oncology and cellular and genetic treatments.
• Cordis reported the launch of its REGATTA steerable guidewires that assist the placement of catheters and other interventional devices in coronary arteries. The devices are designed to facilitate access to side branches with features that ease placement in highly narrowed arteries. The different selections for each version refer to variations in tip type, tip profile, lateral support and/or wire length. Cordis produces interventional vascular technology.
• Draximage (Mississauga, Ontario) submitted an abbreviated new drug application to FDA for its generic kit for the preparation of Tc-99m Sestamibi for injection (Draximage Sestamibi), a nuclear medicine imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart in patients undergoing cardiac tests. Once its product is approved, Draximage said it plans to enter the MPI market after the key patent for the currently marketed Tc99m Sestamibi product expires, expected in 2008 for the U.S. Draximage said it also plans to file for market approvals in other jurisdictions, including European countries. Draximage makes diagnostic and therapeutic radiopharmaceuticals.
• ev3 (Plymouth, Minnesota) reported FDA approval of its Prot g RX carotid stent. The company said that the stent, when used in conjunction with its SpidRX embolic protection device, is indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery. The SpideRX was cleared by the FDA for use in the carotid artery in February 2006. FDA approval was supported by the Carotid Revascularization with ev3, Arterial Technology Evolution (CREATE) trial demonstrating the safety and effectiveness of the Prot g stent and the Spider embolic protection device when used together to treat carotid artery disease patients at risk for stroke and also at high-risk for adverse events from surgery. CREATE Trial enrolled 419 patients in 31 centers in a prospective, non-randomized study. The results of the trial compared favorably with performance criteria that were based on the results of previous carotid stenting trials.
• FlowCardia (Sunnyvale, California) reported the availability of the Crosser 14P, Crosser 14S and Crosser 18 chronic total occlusion (CTO) recanalization catheters in the European Union. The catheters are delivered using standard guidewires to the site of the occlusion in the legs. They then utilize high-frequency vibration to facilitate guidewire crossing of the occlusion allowing for subsequent plaque debulking (removal), balloon angioplasty or stent placement. For many patients, this cath-lab based, minimally invasive approach to CTO recanalization can eliminate the need for potentially traumatic bypass graft surgery or leg amputation. FlowCardia produces endovascular devices for coronary and peripheral CTO recanalization.
• Greatbatch (Clarence, New York) reported the qualification of its first battery model to incorporate nanoSVO for use in implantable medical devices. This marks an advancement for the silver vanadium oxide (SVO) high-rate battery product line, Greatbatch said. nanoSVO improves cathode material homogeneity, yielding more reliable battery performance. The qualification of this cathode manufacturing process represents the integration of Greatbatch’s commercialization expertise and the intellectual property gained from its acquisition of NanoGram Devices. Greatbatch makes components used in implantable medical devices and other demanding applications.
• ProRhythm (Ronkonkoma, New York) reported that the first patient in its first pivotal trial recently was treated using its High Intensity Focused Ultrasound (HIFU) Ablation System, meaning that the energy produced and used is focused in a small area. The initial procedure — which the company characterized as a critical milestone for it — was performed at Beaumont Hospital (Royal Oak, Michigan) Richard Fischer, company CFO, told CDU that to treat AF, the main therapy is often medication, with a drug like Coumadin. However, in about 60% of patients with AF, medication does not stop the symptoms, primarily an uncontrollable rapid heartbeat that can produce various co-morbidities and result in a serious decline in health. This problem is driving companies to seek a variety of treatments, most, to date, being fairly invasive.
• Rex Medical (Conshohocken, Pennsylvania) reported that in an international clinical study it has been able to successfully retrieve its Option vena cava filter thus far at up to 107 days. The company reported that 29 patients enrolled to date in that international study have been successfully implanted with the Option filter for the prevention of PE resulting from blood clots or deep vein thrombosis (DVT), under the direction of Adrian Ebner, MD, chief of interventional procedures and cardiovascular surgery, French Hospital (Asuncion, Paraguay). In several patients evaluated for retrieval, the filter was successfully retrieved most recently at times ranging from 84 to 107 days following filter implant by Anthony Venbrux, MD, professor of radiology and surgery, director, cardiovascular and interventional radiology at George Washington University (Washington). PE occurs when thromboemboli become dislodged from the deep veins located in the legs and travel through the blood stream to the lungs. If left untreated, PE has a mortality rate in excess of 30%. The Option filter is designed to remain either permanently in place or to be removed from the patient if the doctor determines the patient is no longer at substantial risk for PE.
• Signalife (Greenville, South Carolina) reported completing development of a prototype device to be used for objective evaluation of ECG/IC (electrocardiogram and intracardiac) data recorders. This mechanism for evaluating all ECG systems will provide physicians, hospitals, and other end users with information regarding the clinical efficacy of various ECG systems across the market, which will allow them to better evaluate their future purchasing decisions. Signalife is a life sciences company focused on the monitoring and detection of disease through biomedical signal monitoring. It uses its signal technology to design and develop medical devices that simplify and reduce the costs of diagnostic testing and patient monitoring in an ambulatory setting.
• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance for the Venture wire control catheter on a rapid exchange delivery platform, a delivery design that accommodates shorter guidewires and may result in quicker, easier coronary procedures. The catheter is designed with a deflectable tip — a feature that allows interventional cardiologists to treat difficult-to-reach areas of the coronary anatomy. Capable of bending 90 degrees, the deflectable tip helps physicians with control and precision when navigating complex turns in the artery, and it provides guidewire support when attempting to access partially blocked vessels. With approval of the rapid exchange delivery platform, the catheter now accommodates guidewires of any length, including the shorter guidewires most commonly used in interventional procedures.
• Tryton Medical (Newton, Massachusetts) reported completing enrollment in its Tryton First-in-Man Study. The multi-center clinical trial evaluated the safety of Tryton’s side-branch stent in the treatment of coronary bifurcation lesions. Tryton makes stents designed to treat bifurcation lesions
• W.L. Gore & Associates (Flagstaff, Arizona) reported that the first patient has been enrolled in a FDA-approved IDE study for the 45 mm GORE TAG thoracic endoprosthesis for treatment of aneurysms of the descending thoracic aorta. The device provides a minimally invasive alternative to open surgery for treatment of aneurysms of the descending thoracic aorta. The device internally relines the thoracic aorta and isolates the diseased segment from blood circulation. It is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient’s groin. Gore manufactures vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery.