From CD&Ds

Royal Philips Electronics (Amsterdam, the Netherlands) reported that it will lead a new European Union (EU)-funded research project aimed at improving care of heart patients through the development of telemonitoring solutions. The HeartCycle project, which follows the MyHeart project in the EU, was launched on March 1, and will be one of the largest biomedical and healthcare research projects within the EU, according to Philips.

Public and private partners from 18 academic, industrial, medical and research organizations from nine different European countries and China will team up in the project, the company said. HeartCycle will run for four years and has a budget of some €21 million, of which about €14 million will be funded by the European Union as part of the EU 7th Framework Program.

According to Philips, participants in the HeartCycle consortium "will work to improve the quality of care for coronary heart disease and heart failure patients by developing systems for monitoring their condition at home and involving them in the daily management of their disease." The systems will involve the use of "unobtrusive" sensors built into patients' clothing or bedsheets and home appliances such as weight scales and blood pressure monitors.

The consortium defined its goal as the development of dedicated software that analyzes the acquired data, and that can be programmed to provide feedback on the patient's health status, plus his or her adherence to prescribed therapies and progress toward achieving health milestones. It also aims to develop mechanisms to report relevant data back to clinicians automatically so that they can prescribe personalized therapies and lifestyle recommendations.

"The greatest challenge and opportunity for the management of long-term medical conditions is to help patients to help themselves," said John Cleland, MD, head of the department of cardiology at the University of Hull (Hull, UK), past chairman of both the Working Group on Heart Failure of the European Society of Cardiology and of the British Society for Heart Failure, and chief medical officer of the HeartCycle project.

"Investing directly in people who need help, and not just in services that do things to or for them, makes sense in terms of improved care, greater affordability and the effective deployment of scarce nursing and medical resources," Cleland said.

Henk van Houten, senior VP of Philips Research and head of the Healthcare Research program, said, "By developing systems that remotely monitor heart patients and motivate them to adhere to treatment regimes and adopt beneficial lifestyles, we hope to improve the survival of people with heart disease as well as to contain the overall cost of care. The development of such systems can only be achieved efficiently via multi-disciplinary partnerships between hardware engineers, software engineers, textile manufacturers, industrial designers, clinical experts and healthcare providers, as is the case in the HeartCycle project."

According to Philips, the earlier MyHeart project in the EU "developed advanced telemonitoring technologies and service concepts to enable people to play an active role in maintaining their health." It said that in the course of that project, home-based disease management was identified as a potential opportunity for improving medical standards of care and added that the HeartCycle project "aims to extend this disease management concept for specific patient groups, with a focus on improving patient compliance to medication and lifestyle therapies."

Boston Sci says enrolling in 'olimus' registry under way

Boston Scientific (Natick, Massachusetts) said the first patient has been enrolled in its PROmus, ENdeavor and CYpher (PROENCY) European registry. The company said the registry is the first to observe different "olimus"-eluting coronary stents. It will collect real-life clinical outcome data for Boston Scientific's Promus everolimus-eluting coronary stent and compare them with data from Johnson & Johnson's (New Brunswick, New Jersey) Cypher sirolimus-eluting stent and Medtronic's (Minneapolis) Endeavor zotarolimus-eluting stent in patients in routine clinical practice.

The Promus stent is the Xience V everolimus-eluting coronary stent system manufactured by Abbott (Abbott Park, Illinois) and also distributed by Boston Scientific under a private-label agreement. The Promus is an investigational device in the U.S., with its premarket approval application expected to receive FDA approval soon.

The registry will enroll up to 2,500 patients with simple and complex lesions at multiple sites in several European countries. Of the patients at each site, half will receive the Promus stent and half will receive either the Cypher or the Endeavor stent from Medtronic (Minneapolis) to attain a 2:1:1 ratio of Promus, Cypher, Endeavor stents, respectively. The primary endpoint of the registry will be the rate of cardiac death, all myocardial infarction and target vessel revascularization at 12 months.

The Promus, Cypher and Endeavor stents have previously been investigated in randomized clinical trials. Boston Scientific said 12-month data from the SPIRIT III Trial, presented last October at the Transcatheter Cardiovascular Therapeutics conference in Washington, "confirmed earlier positive clinical results for the Xience V (Promus) stent."

Biotronik in launch of Home Monitoring in India

Biotronik (Berlin), developer of remote monitoring technologies for cardiac devices, has launched its Home Monitoring system in India, and also has established commercial headquarters in India for both its Cardiac Rhythm Management and Vascular Intervention businesses. This wireless telecardiology solution was introduced on Feb. 12 with the implant of Biotronik's newest pacemaker, the Cylos DR-T with Closed Loop Stimulation (CLS), at the Escorts Heart Institute & Research Center (New Delhi).

The Cylos DR-T, with CLS, is part of Biotronik's most technologically advanced bradycardia product portfolio, delivering proven physiologic rate adaptive therapy for optimized hemodynamics in pacemaker patients.

The Escorts Heart Institute & Research Center and other clinics like it across India, now can continuously monitor their patients with Biotronik cardiac devices remotely, allowing physicians to verify diagnostic and technical device data online. Home Monitoring is also for patients with implantable cardioverter defibrillators and cardiac resynchronization therapy devices, with continuous automatic daily data transmissions of the patient's cardiovascular status to the physician from anywhere in the world using an antenna integrated in the device and the GSM telephone network.

Biotronik's Home Monitoring system has been introduced in 45 countries worldwide and is available for 100,000 implanted cardiac devices, with more than 2,500 clinics participating.

Medtronic launches new delivery system for Talent graft

Medtronic (Minneapolis) reported the European market launch of the Talent Abdominal Stent Graft on the new Xcelerant Hydro Delivery System, which the company cited as featuring a hydrophilic coating designed to aid navigation of the device through "tight and tortuous arteries" by reducing friction with the artery wall.

"The Xcelerant Hydro Delivery System is a significant innovation that will make endovascular repair (EVAR) using the Talent Stent Graft a treatment option for more patients with abdominal aortic aneurysms," said Dierk Scheinert, MD, PhD, of Park-Hospital and University of Leipzig-Heartcenter (Leipzig, Germany). He was the leader of the first team worldwide to implant the device using the new delivery system. "It will simplify the procedure for endovascular interventionalists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous."

The iliac arteries connect the femoral arteries, the entry point for stent grafts, to the aorta, the site of aortic aneurysms. The company said abdominal aortic aneurysms are present in an estimated 1 million people in Europe

Medtronic said the Xcelerant Hydro Delivery System represents the seventh generation of innovation for the Talent Abdominal Stent Graft, which was introduced in Europe in April 1998. "In bench testing, the Xcelerant Hydro Delivery System was shown to generate a 99% reduction in friction compared to the previous delivery system, which does not have the hydrophilic coating," the company said.

The Xcelerant Hydro Delivery System features what Medtronic called "a uniquely integrated sheath that contributes to the system's low-profile characteristics, which are intended to enable excellent tracking and access through small vessels."

"Katie Szyman, VP and general manager of the Endovascular Innovations business of Medtronic, said the system "represents our latest innovative contribution to this exciting field. Combined with the Talent Stent Graft, Medtronic now offers endovascular physicians in Europe an even stronger option for their EVAR procedures."

More than 130,000 patients have been treated with Medtronic aortic stent grafts dating to 1995. The company said it offers "the broadest portfolio of endovascular stent grafts in the industry," including the AneuRx AAAdvantage Abdominal Stent Graft System in the U.S., and

CircuLite advances Synergy program in pursuit of CE mark

CircuLite (Hackensack, New Jersey) said it has advanced its Synergy Pocket Circulatory Assist Device clinical program into a 20-patient trial designed to lead to CE-mark approval for long-term implantation in heart-failure patients.

This follows successful completion of a first-in-man pilot study of Synergy in four patients. Synergy is a micro implantable blood pump, the size of a AA battery, that can be implanted superficially in a "pacemaker-like" pocket. The device provides long-term, partial circulatory support in patients with chronic heart failure.

Paul Southworth, president/CEO, said, "We believe Synergy represents a potential breakthrough for the long-term support of patients with chronic heart failure who remain symptomatic despite optimal medical management, and, if eligible for a heart transplant, may need to wait more than 12 months for the procedure."

The European registration trial is planned to enroll 20 patients with chronic heart failure and will evaluate the safety and quality-of-life improvements associated with device support of longer than six months.

Seven patients have been implanted, with six implants performed by Bart Meyns, MD, PhD, at Gasthuisberg University Hospital (Leuven, Belgium), the site of the first-in-man trial. Another patient was implanted at Hannover Medical School (Hannover, Germany) by Drs. Andr Simon and Martin Str ber.

A third trial site, University Hospital (M nster, Germany), has completed training and is now screening patients for the CE-mark trial.

First implants for Cognis and Teligen CRT-D devices In Europe

Boston Scientific (Natick, Massachusetts) reported the first European implants of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (ICD). Physicians performed 40 implants in 14 hospitals in six countries.

The company said the Cognis and Teligen devices are designed to eliminate the compromises physicians often must make among device size, battery longevity and features. They are among the world's smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. It said the new CRT-D and ICD "offer features based on significant engineering advances, including extended battery longevity, self- correcting software and improved programming technology."

The devices are built on an entirely new technology platform, it said, and "are the result of a multi-year R&D effort to provide physicians enhanced clinical options for their patients."

The Cognis CRT-D and Teligen ICD received CE-mark approval in January. The company said it plans to build to a full launch in Europe and other international markets in the second quarter.

Boston Scientific also reported CE-mark approval of its Acuity Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure

The company said the product features a spiral design and small lead tip profile (4 Fr) for placement of the lead even in difficult-to-access veins of varying sizes.

Hatch Medical brokering CTO device of UK firm

Hatch Medical (Duluth, Georgia), a medical device incubator and technology brokerage firm, reported an agreement with Medical Miracles (Leeds, UK) to broker its CE-marked POLAR (Path Of Least Arterial Resistance) device for chronic total occlusion (CTO). POLAR generates reciprocal and lateral movements at the distal end of standard guidewires with frequencies of 16 Hz to 100 Hz when passed through an angioplasty balloon catheter, allowing clinicians to confidently cross occluded vessels.

Hatch noted that percutaneous intervention of a CTO remains one of the more difficult technical challenges for interventional practitioners, "despite the progress made in the field of PI in the past decade."

"Failure to revascularize a CTO often leaves the patient with either the more invasive option of bypass graft surgery or continuing medical therapy, which may or may not control their symptoms," Hatch said, adding that neither is optimal.

The POLAR device is available for licensing or acquisition to interested third parties through an exclusive agreement with Hatch.

Report finds blood pressure raised as result of aircraft noise

Night-time noise from aircraft or traffic can increase a person's blood pressure even if it does not wake them, according to a study published last month in the European Society of Cardiology's (ESC; Sophia Antipolis, France) European Heart Journal. Scientists from Imperial College (London) and other European institutions monitored 140 sleeping volunteers in their homes near London Heathrow and three other major European airports.

The researchers measured the volunteers' blood pressure remotely at 15-minute intervals and then analyzed how this related to the noise recorded in the volunteers' bedrooms. ESC noted that people with high blood pressure have an increased risk of developing heart disease, stroke, kidney disease and dementia.

The researchers found that volunteers' blood pressure increased noticeably after they experienced a "noise event" – a noise louder than 35 decibels – such as aircraft traveling overhead, traffic passing outside, or a partner snoring. They said this effect could be seen even if the volunteer remained asleep and so was not consciously disturbed.

Aircraft noise events caused an average increase in systolic blood pressure of 6.2 mmHg and an average increase in diastolic blood pressure of 7.4 mmHg. Similar increases in blood pressure also were seen for other noise sources such as road traffic.

The researchers found that the increase in blood pressure was related to the loudness of the noise, so that a greater increase in blood pressure could be seen where the noise level was higher.

End points successfully met in first-in-man trial of CircuLite

CircuLite (Hackensack, New Jersey) reported preliminary top-line results of a pilot first-in-man study of four patients who have been implanted with the Synergy Pocket Circulatory Assist Device. Synergy is a micro-implantable blood pump, the size of a AA battery, that can be implanted superficially in what the company describes as a "pacemaker-like" pocket. The device is designed to provide long-term, partial circulatory support in patients with chronic heart failure.

The pilot study was initiated last June, evaluating Synergy in individuals awaiting a heart transplant. All four patients reached the primary endpoint of successful heart transplantation, with one patient supported for seven months. The company said that final study data will be presented at a future medical meeting.

The pilot study cohort will be included in CircuLite's 20-patient long-term support CE-mark trial that is currently enrolling patients. The trial is designed to support a CE-mark filing at the end of 2008.

The key component of the Synergy device is the micro-pump technology acquired by the company after eight years of development at the Helmholtz Institute (Aachen, Germany), which CircuLite characterized as "one of the world's leading centers for blood pump technology development."

1st installation of TopSpin IVMRI system reported

TopSpin Medical (Tel Aviv, Israel) reported the first commercial installation of its Cathamaran Intravascular MRI System at ZOL Hospital (Genk, Belgium), along with the first procedures performed using the system. TopSpin said it expects to install additional Cathamaran systems in the Benelux territory during the current quarter.

The multi-national prospective MIRACLE Study is designed to collect data on a widespread post-market clinical experience to evaluate how lipid quantification with the IVMRI System may be used to guide patient treatment.

Chinese firm reports launch of Cardiograph handset

Qiao Xing Mobile Communication (Beijing), a manufacturer of mobile handsets through its CEC Telecom (CECT) subsidiary, reported the launch of its new C7000A cardiograph mobile handset.

The C7000A has a cardiograph function via which users will be able to perform a basic cardiograph, which they can send to doctors via multimedia messaging service (MMS) through a GPRS network.

The company said doctors would then be able to provide medical advice by sending a text message back to the mobile phone. If there is a serious problem, doctors can call the patient directly.

The handset can run for more than 120 days in standby mode without a recharge, and offers a large, 3-inch LCD screen.

New approvals

Duct Occluder II from AGA receives approval

AGA Medical (Plymouth, Minnesota) said it has received CE-mark approval for the Amplatzer Duct Occluder II (ADO II) and has launched the device in Europe. The company said the ADO II expands its family of occlusion devices designed to occlude or close a patent ductus arteriosus (PDA), a type of congenital heart defect that occurs when the ductus arteriosus blood vessel fails to close after birth, as it normally should.

The ADO II is a self-expanding nitinol mesh device and is designed to be introduced in a minimally invasive fashion through a catheter. The device has two retention disks positioned on either side of the duct and connected by a waist. The device is designed with a screw mechanism for attachment to the deployment cable that allows the device to be withdrawn and repositioned, if necessary, prior to release from the cable.

The device treats a patent ductus arteriosus, an open channel in every fetus that allows blood to bypass the lungs, and is no longer used when the baby takes its first breath after birth. AGA said that shortly after the baby's first breath, the ductus arteriosus should close permanently.

The original Amplatzer Duct Occluder received the CE mark in 1998 and was approved by the FDA in 2003. It is currently under review by Japanese regulatory authorities.

• Nfocus Neuromedical (Palo Alto, California) reported CE-mark approval for the CardioVasc Stent-Graft and delivery system, a minimally invasive device for treating patients with saphenous vein graft (SVG) lesions from a previous coronary bypass, vessel perforations and coronary artery aneurysms.

The CE mark allows the company to begin marketing the CardioVasc product in the European Union, and indicates that the product complies with the appropriate quality and safety standards.

Saphenous vein graft disease has been a problem facing the cardiologist since the early days of coronary artery bypass graft (CABG) surgery. In CABG surgery, a segment of the patient's own leg vein (the saphenous vein) may be removed and used to create an artificial conduit to bypass areas of blood flow blockage that have built up in the patient's coronary artery.

After CABG surgery, the SVG bypass itself may become blocked over time by the same type of disease that affected the patient's original coronary artery. The result is a need to reopen the diseased SVG vessel and restore flow. This second treatment again can be yet another surgery – or alternatively, the SVG may be treated via angioplasty and stenting procedures using less-invasive endovascular techniques.

The CardioVasc Stent-Graft device is a permanent implant delivered via a less-invasive catheter procedure for patients that have a diseased SVG from a previous CABG surgery.

The CardioVasc is not approved in the U.S.

• St. Jude Medical (St. Paul, Minnesota) said it has received CE-mark approval of two integrated components – the Cool Point Irrigation Pump and the IBI-1500T11 Cardiac Ablation Generator. Designed, the company said the products were designed "to enhance physicians' ability to perform successful cardiac ablations, [and] were developed for use together with the St. Jude Medical family of Therapy Cool Path irrigated catheters."

In addition to simplicity in set-up and operation, the Cool Point Irrigation Pump provides what St. Jude termed "important control, monitoring and safety features. It enables physicians to program the flow rate they determine to be optimal – up to 40 milliliters per minute – and to monitor the total volume of irrigation solution delivered through an easy-to-read display."

The pump's tubing includes an in-line occlusion detector that monitors flow pressure between pump head and catheter tip, providing an alert if flow pressure increases substantially relative to the flow rate an indication that irrigation ports on the catheter tip may be blocked. The pump also has redundant bubble detectors, each able to detect bubbles as small as two microliters.

The new generator is designed for ease of use with the Cool Point Irrigation Pump. It is programmed for fully automated communication with the pump.

The integrated pump and generator accommodate the Therapy Cool Path family of open-irrigated catheters, which are designed to maintain lower tip-to-tissue temperatures, thereby creating wider and deeper lesions.

St. Jude also noted that the Cool Path family was recently expanded with the CE-mark approval of the Cool Path Duo irrigated ablation catheter, designed for uniform cooling of the entire length of the tip electrode.

St. Jude also reported approval from Japan's Ministry of Health, Labor and Welfare (MHLW), and reimbursement approval, of the SJM Tailor Flexible Ring and SJM Tailor Flexible Band, the company's first products in Japan for repairing diseased heart valves. The Tailor Flexible Ring and the C-shaped Tailor Flexible Band are designed to provide surgeons with a range of easy-to-implant options for the repair of the heart's mitral and tricuspid valves.

The Tailor Flexible Ring and Band are designed to accommodate the natural movement of the annulus, and St. Jude said physicians can tailor the products to meet precise patient needs. The Ring provides anterior and posterior support of the valve while allowing necessary motion as the valve opens and closes.

"With the approval and introduction of the Tailor Ring and Band, St. Jude Medical is offering its first valve repair solution in Japan, building on our long-established tradition of assisting Japanese surgeons with safe and effective solutions for the treatment of valve disease," said Paul Bond, president, SJM Japan.

St. Jude says it is the leading supplier of mechanical heart valves in Japan.

In 2005, the number of valve repair procedures performed in Japan increased more than 20% from the prior year, to nearly 6,400 procedures, according to statistics on thoracic and cardiovascular surgery (as reported in the September 2007 issue of General Thoracic and Cardiovascular Surgery). It is estimated that surgeries to repair faulty valves will continue to increase as the average age of the population increases.

The Tailor Flexible Ring and Band, which has already received regulatory clearance in the U.S. and Europe, will be launched immediately in Japan.

• Tryton Medical (Newton, Massachusetts), a developer of stents designed for the treatment of bifurcation lesions, said it has received the CE mark for its Side-Branch Stent.

The Side-Branch product is a cobalt-chromium, balloon-expandable coronary stent developed, the company said, "for the treatment of the entire spectrum of coronary artery bifurcation disease."

Tryton said about 540,000 procedures are performed annually to address bifurcation lesions, accounting for 20% of all coronary lesions treated.