Abbott Vascular (Santa Clara, California) earlier this month submitted an application for Shonin marketing authorization license to Japan's Ministry of Health, Labor and Welfare/Pharmaceuticals and Medical Devices Agency to gain approval for its Xience V everolimus-eluting coronary stent system to treat coronary artery disease.
The Shonin application for Xience V consisted of safety/efficacy data from the SPIRIT III clinical trial, including data from a Japanese population of 88 patients. Results from the SPIRIT III U.S. pivotal clinical trial demonstrated the superiority of Xience V over Boston Scientific's (Natick, Massachusetts) Taxus paclitaxel-eluting coronary stent system in the primary endpoint of in-segment late loss at eight months, the company reported.
"Results of the SPIRIT III Japan Registry were very similar with those of the U.S. randomized clinical trial, which was the first head-to-head clinical trial to demonstrate the superiority of one drug-eluting stent over another drug-eluting stent," said Daniel Estay, divisional VP of Abbott Vascular Asia Pacific and Japan.
The Xience V stent uses everolimus, which has been shown, the company said, to reduce tissue proliferation in the coronary vessels following stent implantation, and is built upon Abbott's Multi-Link Vision coronary stent system, the company calling it "the world's market-leading bare-metal stent."
Abbott said the Vision platform "has a flexible design and facilitates ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery."
Shigeru Saito, MD, director of cardiology and catheterization laboratories at Shonan Kamakura General Hospital and principal investigator for the SPIRIT III Japan Registry, said that the data "indicate that Xience V is a true next-generation drug-eluting stent that combines advanced technology with outstanding clinical benefits in the treatment of coronary artery disease."
In other news related to the Xience stent, Medtronic (Minneapolis) has launched an international study comparing its Endeavor Resolute zotarolimus-eluting DES with the Xience V, which elutes everolimus. The first implants in the RESOLUTE III All-Comers trial took place in Europe in May.
The teams of Stephan Windecker, MD, of University Hospital Bern (Bern, Switzerland), one of three principal investigators in the trial, and William Wijns, MD, of the Cardiovascular Centre Aalst in Belgium, enrolled the first patients in RESOLUTE III. Sigmund Silber, MD, of the Heart Catheterization Centre (Munich, Germany), and Patrick Serruys, of the Heartcenter (Rotterdam, the Netherlands), are the trial's other principal investigators.
RESOLUTE III is the pivotal trial for the Endeavor Resolute drug-eluting stent and one part of the overall RESOLUTE clinical program. RESOLUTE III will randomize roughly 2,300 patients, in a one-to-one manner, to the Endeavor Resolute or Xience stent at 15 to 20 international medical centers in countries where both stents are commercially available.
The primary endpoint for RESOLUTE III is target lesion failure, a composite of cardiac death, myocardial infarction and target lesion revascularization, at one year.
The Endeavor Resolute stent received CE-marking in October 2007 and is available in more than 100 countries outside the U.S. The stent uses a new biocompatible polymer called BioLinx, which is designed to confer the same biocompatibility as the Endeavor stent's phosphorylcholine polymer while extending the duration of drug exposure in the vessel.
Medtronic said that the BioLinx is the first polymer created specifically for DES use.
Report: For kids in Spain, too much food, too little foot
One out of every four obese school-aged children (6 to 12 years old) develops an illness typically associated with adults that are nearly 40 years old, metabolic syndrome, due to one clear factor: child obesity.
As the result of a study by the chair of the Institute of Food Nutrition and Technology at the University of Granada, Angel Gil Hernandez warns that this syndrome provokes arterial hypertension in children, insulin resistance, and, in the long term, Type 2 diabetes, associated with numerous cardiovascular pathologies and whose treatment will mean elevated costs for the Spanish Health Service in the future.
According to Hernandez, child obesity currently affects 17% of Spanish children, who suffer hypertension and biochemical consequences (such as a high level of triglycerides in plasma) because of it. The appearance of cardiovascular illnesses associated with obesity and diabetes will mean a grave problem in only a few years, postulates Hernández.
The "ill-fated combination" of inadequate nutrient intake and a sedentary lifestyle, or cases of physical inactivity, can be found among the causes of child obesity, "one of the pandemics of the 21st century," he said. "Contrary to what most parents believe, physical exercise is the key to combat obesity, child or adult: We could say that, along with the genetic predisposition, 70% of our figures are owed to exercise and only the remaining 30% correspond to diet."
Hernández recalls a Spanish saying that asserts that the secret of a good diet is "a little food and lots of foot."
According to the estimates of the study group directed by Hernandez, if the pattern continues, the cases of Type 2 diabetes in child population will quadruple by 2020.
Cardiac Dimensions reports first implant in trial of Carillon
Cardiac Dimensions (Kirkland, Washington) reported the first implant of its Carillon Mitral Contour system as part of the new TITAN study. The procedure was performed by Michael Haude, MD, chief of cardiology at the Stadtische Kliniken Neuss (Neuss, Germany). TITAN is the latest clinical effort initiated by Cardiac Dimensions. The study, which will be conducted in six centers across Europe and enroll up to 50 patients, will assess safety and efficacy at one, six, 12, 18 and 24 months, then annually at three, four and five years.
The Carillon system is a percutaneous treatment of functional mitral regurgitation (FMR), currently under investigational use in Europe, South America and Australia.
"The procedure went very smoothly and we were quite satisfied with the result," Haude said. "The patient had been in the hospital for several weeks prior to the procedure and is now doing very well."
Haude previously participated in the company's AMADEUS study. "In my experience with the device, the Carillon holds a great deal of promise for patients with functional mitral regurgitation," he said. "It has provided clinical benefit to those patients in whom I have placed it, and I see a tremendous opportunity for many more patients."
Roughly 5 million people in the U.S. and more than 20 million people worldwide suffer from heart failure. Cardiac Dimensions said the majority of those patients also suffer from dilated cardiomyopathy and FMR and are "inadequately treated using medical management."
It added that while surgical options exist and can be effective in reducing FMR," they are infrequently used due to the burden of the surgery itself, which can be associated with high operative morbidity and mortality rates."
The Carillon system combines an implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors, which is delivered percutaneously via jugular access under fluoroscopic guidance.
The implant is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral regurgitation.
The company said pre-clinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements, among other key parameters including NYHA class, six-minute walk times, and quality of life.
Cordis begins sales of Medinol Presillion coronary stent
Medinol (Tel Aviv, Israel) reported the availability of its bare-metal Presillion cobalt chromium (CoCr) coronary stent in Europe. The distributor of the stent, Cordis (Miami Lakes, Florida), said the system "provides flexibility that delivers the stent through the arteries, and conformability and scaffolding that adapts to the vessel when deployed.
The Presillion stent consists of alternating rings of narrow and wide struts that Cordis said are optimized to give "excellent flexibility with the narrow struts while maintaining optimal radial strength with the wide struts."
It said the "unique stent design includes an adaptive closed cell architecture that is capable of differential lengthening. This enables the stent to be flexible in the unexpanded configuration, and support the vessel while conforming to its curvature in the expanded configuration."
The Presillion stent is available in lengths that range from 8 mm to 33 mm and in a variety of diameter sizes, from 2.5 mm to 4.0 mm.
Medinol received CE-marking for the stent in March. Cordis is the exclusive global distributor of the Presillion.
Israeli firm launches stent in three European countries
ITGI Medical (Or Akiva, Israel), a developer of tissue-covered stents reported the launch of its Over and Under Pericardium Covered Stent (PCS), in the UK, Switzerland and Ireland. Over and Under is a stent covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. It is intended for situations such as degenerated saphenous vein grafts (SVG), aneurysms and perforations.
The first in a planned series of heterologous tissue-covered stents, Over and Under is indicated for treatment of bypass stenosis, aneurysms and emergency situations such as perforations.
ITGI is launching Over and Under PCS in the UK, one of the largest target markets in Europe, in collaboration with Pyramed (Basingstoke, UK)), the company's UK distributor. It is launching its sales in Ireland together with its local distributor, Lecks Medical, and in Switzerland through Euromed Endovascular.
MIV Therapeutics moves up launch of trial for VESTAsync
MIV Therapeutics (Atlanta), a developer of next-generation coatings and advanced drug-delivery systems for cardiovascular stents and other implantable medical devices, said the first patients have been enrolled in the registration trial of its VESTAsync polymer-free DES in a trial in Brazil.
The company said the "excellent" nine-month human safety and efficacy data reported at the annual scientific sessions of the American College of Cardiology (Washington) in Chicago in March, led it to accelerate its timeline for the VESTASYNC II trial. The trial is designed to test the efficacy of the VESTAsync in a sufficient number of patients to form the basis of a regulatory filing for marketing approval in Europe.
The company said it is anticipated that these trial findings also will be part of an eventual submission to the FDA.
Alexandre Abizaid, MD, PhD, chief of coronary intervention at the Institute Dante Pazzanese of Cardiology (Sao Paulo, Brazil), is a principal investigator in this 120-patient, multi-center, randomized, controlled study. In the study, 90 patients will receive the VESTAsync nano-porous hydroxyapatite (HAp) coated drug-eluting stent, while 30 will receive the VESTAcor stent, the company's nano-porous HAp-coated stent, which contains no drug.
The primary endpoint is late lumen loss as measured by quantitative coronary angiography at nine months. Secondary endpoints will include major adverse cardiac events and volumetric obstruction. The company said it will use the data from te study to support a CE mark application by the end of 2009.
CIN-prevention study with PLC's RenalGuard launched in Italy
PLC Systems (Franklin, Massachusetts) said the ethics committee of the Centro Cardiologico Monzino (CCM-University of Milan; Milan, Italy) has approved the planned randomized clinical trial to evaluate the use of PLC's RenalGuard in the prevention of contrast-induced nephropathy (CIN) in high-risk patients undergoing catheterization procedures at its institution.
The investigators for the trial are Antonio Bartorelli, MD, director, interventional cardiology, and Giancarlo Marenzi, MD, chief of the intensive cardiac care unit.
The trial is designed as a prospective, open, randomized trial to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy, compared to standard overnight hydration, in the prevention of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function.
The CIN-prevention therapy of induced diuresis and matched hydration therapy will be provided using RenalGuard.
First patients enrolled in TAAMI trial in Poland
Spectranetics (Colorado Springs) has reported enrollment of the first patients into its ThromboAblation in Acute Myocardial Infarction (TAAMI) trial. The trial is a planned 200-patient randomized trial involving major medical centers in Poland.
Starting last quarter, TAAMI enrolled its first six patients and recently initiated the fifth participating hospital.
The trial comprises two treatment groups and enrolls the most complex acute myocardial infarction (AMI) patients those with a large thrombus burden presenting with ST wave elevation myocardial infarction (STEMI). The study group receives excimer laser treatment plus direct stenting. The control group receives balloon angioplasty and stenting.
The primary endpoint is a combination of ST resolution, which is resolution of the EKG ST wave elevation injury pattern and the amount of distal embolization as measured by myocardial blush scores.
The principal investigator of the TAAMI trial, Dariusz Dudek, MD, PhD, a cardiologist at the Jagiellonian University Medical Center (Krakow), said, "This trial will help to assess the effectiveness of laser treatment in conjunction with stenting, and in comparison with a common current combination treatment."
Spiration signs Olympus to distribute IBV Valve in Europe
Olympus Medical Systems (Tokyo) and Spiration (Redmond, Washington) have signed a definitive agreement granting Olympus exclusive marketing and distribution rights in Europe for Spiration's IBV Valve System. Olympus will launch the product in select European countries late this year.
The IBV Valve System is a minimally invasive treatment that has diverse applications for both acute and chronic conditions of the lung. In Europe, the system has received market clearance through the CE mark for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of prolonged air leaks, a complication that can occur following lung surgery.
The IBV Valve System was developed as a treatment alternative for emphysema patients who do not respond well to current medical therapies or are not eligible for invasive surgery such as lung volume reduction or lung transplantation.
The system also may be used to resolve prolonged air leaks that can occur following lung surgery.
For the treatment of emphysema, the IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas. During the minimally invasive procedure, a catheter is passed through a bronchoscope to deploy the small umbrella-shaped valves into the airways of the upper lobes of the lungs.
Under the agreement, Olympus and its distributors will have exclusive marketing and distribution rights for the IBV Valve System in 43 European countries, including the UK and countries belonging to the European Union.
Spiration will manufacture the product and the device initially will be marketed under the Spiration name. Financial terms of the agreement were not disclosed.
Edwards, SunTech Medical open new plants overseas
Edwards Lifesciences (Irvine, Caliofornia), a developer of heart valves, reported the opening of its new heart valve manufacturing plant in Changi North Crescent, Singapore. The facility produces Edwards' Carpentier-Edwards Perimount tissue heart valve replacements, and also serves as the headquarters for the company's Asia-Pacific operations, one of the company's fastest-growing regions.
Edwards treats advanced cardiovascular disease with heart valve therapies, and also provides critical care and vascular technologies. Its products are sold in about 100 countries.
SunTech Medical (Morrisville, North Carolina), a manufacturer of blood pressure monitoring technology, reported the opening of a new manufacturing facility in Shenzhen, China.
Located at Jinxiongda Technology Park, the new 18,000-square-foot facility currently houses a staff of 25. SunTech said it anticipates continued growth as production ramps up in the months ahead.
The new team is headed by Peter Zhang, general manager, who has more then 10 years of operation management experience in multi-national companies.
David Gallick, VP of operations for SunTech Medical, said, "Months of training and preparation have gone into setting up a production area to support the high level of quality demanded by our current standards."
UK distributor signed for Debut of Cardima's EP line
Cardima (Fremont, California) reported a new marketing relationship with Dot Medical (Macclesfield, UK), a distributor specializing in sales and customer training and support for cardiac devices.
The U.S. firm said its EP Ablation System, which incorporates the Revelation T-Flex and Intellitemp products, will assist in meeting the needs of patients with AF and physicians who treat them.
The UK is the first market in Europe where Cardima will commercially launch its EP product line, including the Revelation T-Flex Ablation System.
Dot Medical has its head office near Manchester, in the center of the UK, and its staff covers and supports all EP centers in the UK.
Paracor receives CE mark for pair of HeartNet products
Paracor Medical (Sunnyvale, California) said it has received CE-marking from its notified body, BSI, for the initial two products based upon its HeartNet technology platform. The approval will allow the expanded use of Paracor's HeartNet and HeartNet-D products to treat patients suffering from systolic heart failure within the member countries of the European Union.
The HeartNet implant, an elastic nitinol structure, provides support to the walls of the heart's pumping chambers, the ventricles. This elastic support augments the function of the heart, and is designed to attenuate or reverse the negative remodeling, or enlargement, associated with the advanced stages of heart failure.
The second product, HeartNet-D, incorporates defibrillation electrodes within the elastic structure of the device, providing the potential to address arrhythmia problems that can be life-threatening to heart failure patients. Paracor said the HeartNet-D is compatible with the leading commercially available implantable defibrillation systems.
Both products are delivered in a procedure typically lasting about one hour through a less invasive mini-thoracotomy approach, avoiding some of the problems associated with cardiac procedures that employ an open chest or sternotomy procedure.
The CE-mark application was approved based upon clinical studies assessing the impact of HeartNet and HeartNet-D therapy in more than 50 patients. The studies indicated that, on average, treated patients experienced statistically significant improvements in structural parameters (left ventricular end systolic and diastolic diameters, left ventricular volumes), exercise parameters (6 minute walk), and quality of life measures (Minnesota Living with Heart Failure instrument) through six months of follow-up, with continuing positive trends at the 12-month time frame.
In addition, patients treated with the HeartNet-D therapy maintained appropriate defibrillation safety margins through six months of follow-up testing.
Paracor said it is evaluating the HeartNet therapy in an FDA-approved clinical trial in North America that will enroll more than 270 treatment and control patients. Designated PEERLESS-HF (Prospective Evaluation of Elastic Restraint to LESSen the effects of Heart Failure), the trial will compare the impact of the HeartNet treatment plus optimal medical and device therapy, per current guidelines, to results in patients who continue to receive optimal therapy alone.
Paracor is developing a platform of technologies and products to treat heart failure.
• AGA Medical (Plymouth, Minnesota) reported receiving CE-mark approval to market its Amplatzer Vascular Plug III (AVP III), and said it has launched the device in the European Union. The company said the AVP III further expands its line of occlusion devices designed to embolize, or close, blood vessels and blood vessel malformations in the peripheral vasculature.
The AVP III is a self-expanding nitinol mesh device designed to be introduced in a minimally invasive fashion through a catheter. The device comes pre-attached to a delivery cable by a small screw; the delivery cable enables the physician to precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released.
The company said the nitinol mesh retention discs "ensure the secure positioning of the device, even in high-flow vessels."
The AVP III is under review by FDA for clearance to market in the U.S.
• St. Jude Medical (St. Paul, Minnesota) reported CE-mark approval and European launch of its TigerWire Steerable Guidewire. The newest member of the St. Jude GuideRight family of steerable guidewires, the TigerWire device is designed to enhance physicians' ability to steer through challenging peripheral arteries.
The company said the TigerWire Guidewire's tip is designed with "enhanced flexibility" to aid in navigation through the vessels. Its supportive design provides distinct zones of flexibility that make it easier for physicians to track and position the guidewire through challenging anatomy.