A CD&D

Long considered a problem only for high-income countries, now 80% of deaths connected to high blood pressure (BP) occur in the developing world, according to an article in a recent edition of The Lancet. The report says that cardiovascular disease is now endemic, worldwide, and no longer limited only to developed countries.

Carlene Lawes, MD, of the Clinical Trials Research Unit of University of Auckland (Auckland, New Zealand), and Professor Anthony Rodgers, University of Auckland, and colleagues on behalf of the International Society of Hypertension (Middlesex, UK) estimated the worldwide burden of disease attributable to high BP (=115 mm Hg systolic) for groups according to age (=30 years), sex, and World Bank region in 2001 (the latest year of complete data).

They found that 7.6 million premature deaths (about 13.5% of the global total) and 92 million disability-adjusted life years (DALYs) (6% of the global total) attributed to high BP. About 54% of stroke and 47% of heart disease worldwide were attributed to high BP — about half this burden in people with hypertension (=140 mm Hg systolic), the remainder in those with lesser degrees of high BP.

Within developed countries (including richer European countries, North America, Australia) the proportion of premature deaths due to high BP was higher (17.6%) than within low- and middle-income countries (12.9%), as was the proportion of DALYs due to high BP (9.3% vs. 5.6%). However, overall about 80% of the burden occurred in low- and middle-income countries. Eastern Europe, central Asia, east Asia and the Pacific (including China), followed by South Asia (including India) bore the brunt of these high BP-related deaths. More than one-third of all deaths in the lower-income countries of Europe and central Asia region were related to high BP.

In terms of actual numbers of deaths related to high BP, high income countries experienced 418,000 stroke deaths, 668,000 heart disease deaths, 109,000 deaths due to hypertensive disease, and 197,000 due to other cardiovascular diseases — a total of 1.39 million deaths. These figures were dwarfed by those for high BP-related deaths in low- and middle-income countries: 2.5 million stroke deaths, 2.68 million heart disease deaths, 598,000 hypertensive disease deaths and 445,000 deaths due to other cardiovascular disease — a total of 6.22 million.

The authors conclude: "Most of the disease burden caused by high blood pressure is borne by low-income and middle-income countries, by people in middle age, and by people with lesser degrees of high blood pressure. Prevention and treatment strategies restricted to rich countries or individuals with hypertension will miss much blood-pressure related disease."

In an editorial commenting on the Lancet report, Professor Stephen MacMahon, of The George Institute for International Health at the University of Sydney, and colleagues from the world's five continents, cited data indicating that middle- and low-income regions have a five-times greater disease burden but "less than 10% of the global treatment resource .... This travesty cannot continue to be ignored by those most able to bring about change."

"Ten years ago, The Global Burden of Disease Project predicted this epidemic, yet none of the key players who determine priorities for international health investment have made any real effort to address the problem. As a consequence in the last decade, blood pressure-related diseases have killed more than 50 million people, disabled many more and taken billions of dollars from the already fragile economies of the develooping world. We are calling on the major players to rethink their policies and strategies."

Panel rules in Boston Sci's favor in Medinol patent case

A World Intellectual Property Organization (WIPO) arbitration panel has ruled in favor of Boston Scientific (Natick, Massachusetts), finding that the company's Libert and Taxus stents do not infringe any patents held by its former Israeli stent-supply partner Medinol (Tel Aviv).

Medinol requested the arbitration as part of its 2005 settlement with Boston Scientific, alleging that the Libert and Taxus stents infringed some of its U.S. and European patents. Medinol can appeal the decision to another WIPO panel.

In 2005, Boston Scientific agreed to settle a long-standing dispute by paying Medinol $750 million, which the company said at the time was its largest-ever legal payout to another firm. However, Medinol had been seeking from $4 billion to $5 billion.

The battle began in 2001 after Boston Scientific sought to acquire Medinol, its stents provider, to secure its supply line, but the Israeli firm said the price offered fell far short of value. It then sued Boston Scientific, charging the U.S. firm with establishing a secret facility in Ireland to provide an alternate supply of stents and had appropriated its technology. Boston Scientific responded with counter-suits.

Heart disease mortality for younger women trends up in UK

Coronary heart disease mortality in younger women could be on the rise, according to findings in the open access journal, BMC Public Health, published by BioMed Central. High levels of smoking, increasing obesity and a lack of exercise could all be contributing to this trend, seen in women under age 50.

Steven Allender of the University of Oxford (Oxford, UK) and colleagues from the University of Liverpool, studied data on all deaths in England and Wales between 1931 and 2005. They found that CHD mortality in England and Wales rose steadily throughout the 20th century and peaked in the 1970s.

In most groups, the rate of CHD mortality has been falling steadily since then. Recent generations have experienced much lower CHD mortality rates than those born in the late 19th or early 20th centuries.

However, the researchers saw a leveling off and perhaps even a reversal of the rate of decline in CHD mortality in women under 50. They also found evidence that advances made in terms of CHD mortality among older populations are not being made in the under-60s — something they warn could increase the burden of CHD if left unchecked.

"We observed that CHD mortality among younger age groups has increased in those born in the early 20th century compared to those born in the late 19th century," said Allender. "This requires further study as the public health implications of a decline in survival from CHD in younger age groups may be stark."

Medtronic opens device implantation center in India

Medtronic (Minneapolis) reported opening the first center of excellence for device implantation in India in collaboration with Care Hospital (Hyderabad). Care Hospital will be the first center in the South Asia region to offer hands-on training to cardiologists, the company said. Physicians will be trained on dual-chamber pacemaker therapy and cardiac resynchronization therapy (CRT) implants through hands-on experience under the guidance of electrophysiologist Calambur Narasimhan.

Narasimhan, head of electrophysiology department at Care Hospital and president of the Indian Society of Electrocardiographers, said that a series of training modules has been designed to ensure that physicians receive a quality of care unmatched in the industry.

B. Soma Raju, chairman and managing director of the Care Group of Hospitals, said India, with a population of more than one billion, has very few implantable cardioverter-defibrillator and CRT implant centers compared to the U.S. or Europe. He said the number of patients indicated for these devices is far greater than the number implanted because of a lack of implanting expertise by cardiologists and a lack of awareness among physicians and patients about the latest medical device therapies.

"Medtronic is committed to providing leading-edge education to medical professionals, since training and education are key to ensuring safe, appropriate and efficient use of the company's ... devices and therapies," said Milind Shah, managing director of India Medtronic.

Zoll in new AED pact with Airport Group in Beijing

Zoll Medical (Chelmsford, Massachusetts) reported that the Beijing Airport Group has selected the company's AED Plus to be installed in the Beijing Capital International Airport's newly-built Terminal 3, billing it as the largest single airport building in the world. Plans call for the installation of 80 AED Plus units at Terminal 3, the gateway terminal for the 2008 Beijing Summer Olympics, expected to welcome more than 55 million passengers to the games.

Zoll said the AED Plus is the first full-rescue AED to provide a feature it terms Real CPR Help for rate and depth of chest compressions. It guides rescuers through the complete chain of survival, the company said, helping all sudden cardiac arrest victims, not just those who need a shock.

The AED Plus features Zoll's one-piece electrode for fast and accurate placement and is powered by Lithium camera batteries available from retail stores.

The Beijing International Airport AED project is the first large public AED deployment project in China, Zoll said, and the project marks a "milestone" for public access defibrillators in China.

The company said that before this latest project, 15 AED Plus units were deployed in Terminal 2 of the Beijing airport in 2007, "setting a new standard for public safety devices in China and sparking public demand for more AEDs in public places ...."

Zoll said the AED Plus also will be installed in several other major airports in China managed by the Beijing Airport Group, including Taiyuan and Wuhan airports. The AED Plus also is being deployed in the airport ambulances and emergency centers.

Zoll said Beijing Airport Group plans to add its about 500 AEDs over the next few years.

Richard Packer, president/CEO of Zoll, said, "Our Real CPR Help technology in the AED Plus, along with its graphical interface, can greatly assist the infrequent rescuer through the chain of survival in the event an arrest occurs." Zoll reported that about 150,000 AED Plus units have been deployed in 26 languages worldwide. Zoll sells its products in more than 140 countries, with direct operations, distributor networks and business partners throughout the U.S., Canada, Latin America, Europe, the Middle East and Africa, Asia, and Australia.

The company is marking its 25th anniversary of resuscitation product development in 2008.

Broomwell touts savings for CHF monitoring at home

Home monitoring of patients with congestive heart failure (CHF) using "smart bathroom scales" can save the National Health Service more than 60 million each year and save thousands of lives, according to telemedicine specialist Broomwell Healthwatch (Manchester, UK).

Broomwell has developed a telemedical solution for CHF monitoring, which includes weight control scales and a blood pressure monitor that it says can detect early symptoms associated with CHF, such as fluid build-up weight gain and increased blood pressure, allowing physicians to diagnose problems quickly for fast intervention. Broomwell said its studies show that CHF-related hospital admissions account for 62,582 episodes per year, costing the NHS around 211 million a year. By saving the NHS over 60M a year, Broomwell's CHF monitoring solutions could free up 29% of the overall annual cost spent on CHF by the NHS, Broomwell said.

The scales measure the patient's weight and transmits the data automatically to Broomwell's monitoring center via a home gateway unit. BP readings are transmitted in a similar way. Cardiac clinicians at the center monitor the data for any potentially dangerous trends or deviations from the set parameters meaning prompt action can be taken if needed.
On receipt of the data clinicians at the monitoring centre are automatically presented with the patient's clinical records and medical history.

Broomwell said that the technology has been rolled out across a major city to help monitor and diagnose CHF and has had "positive results."

Joshua Rowe, managing director for Broomwell, said: "This service is great for both CHF patients and the NHS. Patients benefit from the convenience and comforts of Home Monitoring and of having access to instant diagnostic expertise, with regular monitoring via the scales and blood pressure monitor, our expert clinicians can keep an eye out for any potentially dangerous trends, ensuring early intervention to reduce the risk of any long-term damage to the heart.

Broomwell was established in 2004 to provide telemedical monitoring services to general practitioners, walk-in centers, community hospitals and private individuals. Broomwell's systems include the wristwatch-like MiniClinic, linked to the company's monitoring center by a home base station, 12-lead portable ECGs, and weight-control solutions for CHF. These products are supported by Broomwell's 24-hour cardiac monitoring center.

Cerus wins expanded label claims for Intercept

Cerus (Concord, California) said it received expanded label claims in Europe for use of platelets and plasma treated with the Intercept Blood System to prevent transfusion-associated graft-vs.-host disease (TA-GVHD) in at-risk patients. The company said that, while TA-GVHD is a rare disorder, "prevention is critical because it is a condition with greater than 80% mortality and no effective treatment options."

The expanded label claims allow blood banks in Europe to use the Intercept system in place of gamma irradiation for the prevention of TA-GVHD. Cerus said Intercept is the only CE-marked alternative to gamma irradiation.

The company said that Germany's Paul Ehrlich Institute has authorized the use of the Intercept system to replace gamma irradiation for prevention of TA-GVHD and that Afssaps, France's health products afety agency, has made similar authorizations for both the Intercept platelet and plasma systems.

"This label expansion further validates that use of Intercept can improve the quality and safety of the blood supply via pathogen inactivation," said Claes Glassell, president/CEO of Cerus. "By replacing procedures such as gamma irradiation, bacterial testing and CMV screening, Intercept can save blood banks costs associated with screening and testing blood components, while reducing the risk of transfusion-related adverse events and extending the shelf-life of donated blood."

To date more than 100,000 Intercept platelet system kits have been shipped to blood banks to treat platelet components to be administered to thrombocytopenic patients in routine clinical use. Cerus said no reports of TA-GVHD events related to transfusions have been reported where hematology/oncology patients at risk for TA-GVHD were supported with Intercept -treated platelets without gamma irradiation.

Cerus markets the Intercept Blood System for both platelets and plasma in Europe and the Middle East. The company also is pursuing regulatory approvals in the U.S. and other countries. The Intercept red blood cell system is under development.

InterCure's RESPeRATE device to go on the market at Lloyds

InterCure (Lod, Israel) reported that its RESPeRATE hypertension treatment device, which it says has been clinically proven to "significantly lower blood pressure," will launch into full-scale retail distribution within the UK this month through the Lloyds Pharmacy (London) chain.

Lloyds will distribute RESPeRATE in 1,440 stores and for a limited period will be the only nationwide retail chain in the UK to carry the product. As part of the launch, RESPeRATE, which will retail at 199, will be featured in Lloyds' in-store merchandising programs. Lloyds will offer product demonstrations to instruct consumers how to include RESPeRATE in their overall hypertension management regimen.

"With many of our shoppers looking for new ways to manage hypertension with a treatment that fits into their lifestyles, we are pleased to offer RESPeRATE as a complement to our existing line of innovative healthcare products and services," said Justin Woodward, senior marketing manager at Lloyds.

Erez Gavish, president/CEO of InterCure, said, "RESPeRATE is a perfect fit for Lloyds Pharmacy customers looking to take control of their hypertension with the help of their trusted community pharmacy."

Product approvals

Sorin Group wins Japanese approval for Stocker S5 Heart-Lung Machine

The Sorin Group (Milan, Italy) reported Japanese Pharmaceutical and Medical Devices Agency's (PMDA) approval to market its St ckert S5 Heart-Lung Machine in that country. Sorin terms itself "the undisputed leader in the manufacturing and marketing of heart-lung machines," with a share of more than 60% of the installed base of machines worldwide. It said it "works closely ... with perfusionists across the globe in order to ensure that the most advanced features and technologies are adopted and better patient outcome is achieved."

Sorin said its 7,000th perfusion system — an S5 (for St ckert 5th generation) heart-lung machine — was shipped recently to Brisbane, Australia. Already launched in Europe, the U.S. and other international markets, Sorin said the St ckert S5 is the fifth generation of its heart-lung machines and successor to the company's SIII perfusion system.

Sorin said that the smaller footprint of the S5 allows closer positioning of the unit to the patient, reducing line lengths and the possibility of hemodilution. Acoustic alarms and information displayed on the touch-screens describe the status of all monitoring functions of the extracorporeal circuit.

Sorin said that the S5 "has no boot-up time: this means that the pumps are operable three seconds after turning the system on, which is extremely important in emergency situations." The S5 does not use PC-based technology to control the system — all modules are directly programmed to perform a perfusion specific function and are interchangeable.

• Medtronic (Minneapolis) reported receiving the CE mark and launching in the European market its Defender embolic protection filter for use during minimally invasive procedures in carotid arteries and saphenous vein grafts. The first uses of the new filter were carried out recently by interventional cardiologists and vascular surgeons in Germany and Spain, the company said.

Made of braided nitinol, a "memory metal" that resumes its original shape upon deployment, the filter has a low profile and a peel-away delivery sheath that enables physicians to maneuver the device easily across lesions to the desired location, according to the company. When opened, the filter acts as a basket, allowing sufficient blood flow while trapping embolic debris that may become dislodged during a stenting procedure. Without this protection, Medtronic said, embolic debris can flow into other portions of blood vessels — which can lead to a stroke.

Rob ten Hoedt, VP of the CardioVascular business for Medtronic in Western Europe, said the Defender filter now is available throughout the European Union.

"While designing the Defender filter, we conducted extensive research with physicians to understand their needs and what they felt were the most important qualities in an embolic protection device," ten Hoedt said. "They told us they needed a filter that is easy to use, with excellent deliverability and a low crossing profile to minimize the risk of dislodging debris when they cross a lesion."

He said the Defender is engineered to meet all those needs, "even in patients with challenging and complex anatomies."

Andrej Schmidt, MD, of the department of clinical and interventional angiology at the University of Leipzig Heart Center (Leipzig, Germany), said, "For me, the most important attribute for a filter is its crossing profile, and Defender has one of the lowest profiles available on the market."

The Defender filter has a 2.2 Fr (0.029") crossing profile and an extendable 0.014" stainless steel core wire that is designed for both flexibility and support, said Medtronic. "The device's mesh filter basket design allows the filter to fit snugly against vessel walls, even in eccentrically shaped vessels. This reduces the risk of embolization by preventing particles from migrating through gaps and into the bloodstream."

• W.L. Gore & Associates (Flagstaff, Arizona) reported receiving the CE mark for the Gore Preclude Vessel Guard, which it said is the first non-biological membrane indicated as a cover for vessels following anterior vertebral surgery. The company said this advanced biomaterial "reduces the risk of potential vascular injury by providing a permanent and visible plane of dissection around the vasculature to facilitate anterior revision surgery."

The device "enables vasculature management in patients having undergone anterior spinal surgery for degenerative disc disease, including artificial disc replacement, where scarring around the aorta, vena cava and iliac vessels can complicate revising, repositioning, or removing a disc prosthesis."

Gore said the tight microstructured membrane is inserted between the prosthesis and the vessels during the primary surgery. In a revision surgery, the vessels can be identified, dissected from the device and mobilized. The product has a three-layer construction, with two outer layers consisting of a tight expanded ePTFE microstructure, preventing penetration by fibroblasts and minimizing vascular tissue attachment to the device. The company said an elastomeric inner layer "minimizes impingement and provides the stiffness needed for accurate placement.