Researchers at the Technion-Israel Institute of Technology (Haifa) recently reported creating new heart muscle with its own blood supply using human embryonic stem cells. The researchers say the newly engineered muscle could replace cardiac tissue damaged in heart attacks. Their study was published online Jan. 11 in the journal Circulation Research.
According to Professor Shulamit Levenberg of the Technion Biomedical Engineering Department and Professor Lior Gepstein of the Faculty of Medicine, this is the first time that 3D human cardiac tissue, complete with blood vessels, has been constructed that may have unique applications for studies of cardiac development, function and tissue replacement therapy.
Scientists have been stymied in attempts to rebuild damaged heart muscle by a lack of human heart tissue to work with and the failure of transplanted tissue to thrive in its new home. Technion researchers said that the heart tissue they have grown is threaded throughout with a network of blood vessels that would improve the tissue’s survival after transplantation to a human heart, Levenberg says. The researchers engineered the heart muscle by seeding a sponge-like, 3D plastic scaffold with heart muscle cells and blood vessel cells produced by human embryonic stem cells, along with cells called embryonic fibroblasts. Levenberg’s research team used a similar technique in 2005 to grow skeletal muscle from scratch, and she says the lessons learned there helped in designing the heart muscle. For instance, the skeletal muscle study showed that it was important to grow all the different cell types together on the scaffold, and that fibroblasts were key to supporting the blood vessel walls as they developed.
The scientists conducted several tests to make sure the new muscle looked and behaved like heart tissue. Four to six days after being seeded on the scaffold, patches of the new muscle cells began to contract together, a movement that spread until the entire tissue scaffold was beating like normal heart muscle.
The researchers are preparing to transplant the tissue into living hearts in animals to study how well the heart muscle adapts to its new surroundings. Levenberg says that the technique might also prove useful in engineering tissues for other organs such as the liver.
The Technion-Israel Institute of Technology bills itself as Israel’s leading science and technology university, with a worldwide reputation for its work in nanotechnology, computer science, biotechnology, water-resource management, materials engineering, aerospace and medicine.
Response launches sales of NT-proBNP test in Europe
Response Biomedical (Vancouver, British Columbia) reported the European commercialization of its NT-proBNP Test for diagnosing congestive heart failure (CHF). The company said that more than 25 RAMP Systems, as well as NT-proBNP and Troponin I tests, have been sold to hospitals, clinics and medical labs in France through All Diag, its distributor in that country. CE-marking of the NT-proBNP Test was received in late December. Response said it has 13 local distributors in Europe, marketing its RAMP cardiovascular products.
Bill Radvak, company president/CEO, said, “We have built a strong menu of tests in the cardiovascular space, and we believe NT-proBNP is a critical component of our expanding portfolio. We saw compelling results from our clinical trial conducted in 2006 and customers in France have subsequently shown great interest in becoming the first to use this test for CHF.” He said the RAMP platform “has the accuracy one expects from a central lab, combined with the speed and convenience of point-of-care testing.” Response also filed for FDA 510(k) clearance in December, and Radvak said, “We look forward to introducing this test to an even larger market in the months to come.”
The company said NT-proBNP is “widely recognized as a definitive marker for the diagnosis of CHF,” with elevated levels of NT-proBNP indicating the presence of heart failure, providing physicians with an important diagnostic tool in the early detection and management of the disease.
Independent studies have shown that NT-proBNP also is valuable for risk stratification of patients with stable coronary heart disease, as a prognostic marker across the entire spectrum of cardiovascular diseases, potentially detecting early stages of CHF in the absence of clinically obvious symptoms, and for the assessment of prognosis for patients with CHF and for patients who have previously had a myocardial infarction.
The RAMP NT-proBNP Test was developed by Response under license from Roche Diagnostics (Basel, Switzerland).
Cook nears reimbursement OK in Japan for AAA stent graft
Cook Medical (Bloomington, Indiana) reported that it has received preliminary hospital reimbursement for endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) in Japan. The company’s Zenith AAA stent graft is the only device approved for sale in Japan for this type of procedure, it said. Cook said it expects full reimbursement in Japan in March, receipt of which will launch a complete rollout of the Zenith stent graft system across the Asian country.
“Cook was first to the market with this life-saving medical device technology in August 2006 and in just four months we have hit another major milestone with this news of preliminary reimbursement,” said Barry Thomas, global leader of Cook’s Endovascular Therapies division. He said the company’s rapid progress in Japan is the result of a collaborative effort between Cook and its Japanese distributor, Medico’s Hirata.
A requirement of approval includes providing detailed clinical training to Japanese physicians to ensure safe and effective use. The device, which Cook said is the most widely used AAA endograft in the world, has a nine-year history of use in Europe and a seven-year history in the U.S., according to the company.
Cook said the major benefits of the Zenith design for endovascular AAA repair include suprarenal fixation with anchoring barbs to ensure maximal stability and graft-to-vessel sealing, woven polyester graft material that is lightweight, strong and shrink-resistant, and the H&L-B One-Shot Introducer System that allows simple, accurate deployment and positioning of the graft.
1st implant in Zurich launches Boston Scientific’s Promus DES
Boston Scientific (Natick, Massachusetts) last month reported the international launch and initial implantation of the Promus everolimus-eluting stent, making it the only company to offer two distinct drug-eluting stent (DES) platforms. Willibald Maier, MD, performed the procedure on Dec. 21 at University Hospital (Zurich, Switzerland).
Promus is a private-labeled Xience V coronary stent system manufactured by Abbott Laboratories (Abbott Park, Illinois) and distributed by Boston Scientific. The Promus system received CE-mark approval last October, allowing Boston Sci to distribute the stent in select countries of the European Economic Area. It also will be available in selected countries in Asia, Latin America and Eastern Europe, and a U.S. launch is anticipated for 2008.
Abbott launched the Xience V system in Europe in October, and it is available in most major European and Asia-Pacific markets.
“The addition of the Promus stent gives [us] the ability to offer clinicians two highly deliverable options — our market-leading Taxus paclitaxel-eluting stent and Promus, our high-potential everolimus-eluting stent,” said Paul LaViolette, chief operating officer of Boston Sci. “The Promus stent complements our broad DES portfolio and further reinforces [our] leadership in the DES market.”
John Capek, PhD, president of Abbott Vascular (Redwood City, California), said the product roll-out “allows more patients to have access to the advanced, next-generation drug-eluting stent technology that underlies the Xience V system.”
The Xience V system is based on the Multi-Link Vision stent, sold to Abbott as part of the mammoth deal last year in which Boston Scientific acquired Guidant (Indianapolis).
Positive results for the Xience V stent were reported from the SPIRIT II clinical trial at the World Congress of Cardiology in Barcelona, demonstrating that the stent met its primary endpoint of non-inferiority to the Boston Scientific’s Taxus stent as measured by late loss at six months.
Abbott said it would present results from the randomized portion of the SPIRIT III pivotal trial in the first half of this year. SPIRIT III is a large-scale pivotal trial comparing the Xience V stent system to the Taxus system. Some 3 million Taxus stents have been implanted in patients worldwide and clinical follow-up has been conducted on more than 4,000 patients out to four years.
Canada OKs Melody pulmonary valve from Medtronic
Medtronic (Minneapolis) reported receiving a Medical Device License from Health Canada to sell its Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System in that country. The company said the system is the first of its kind in North America to treat patients with congenital and acquired structural heart disease requiring pulmonary valve replacement.
Oern Stuge, MD, president/senior VP of the Cardiac Surgery business of Medtronic, termed the approval a significant milestone for this system, designed to reduce the number of times that certain patients may need to undergo open heart surgery by providing a minimally invasive, catheter-based solution to valve replacement.
The Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System are designed to treat congenital heart defects involving the connection between their right ventricle and pulmonary artery. Medtronic said this type of defect often requires open-heart surgery early in life to implant a prosthetic valved conduit to establish adequate blood flow from the heart to the lungs. “However, the functional life span of these conduits is relatively limited,” the company said, “and as a result most patients with this type of defect are committed to multiple open-heart surgeries over their lifetime.”
The Melody valve and Ensemble system provide a non-surgical means to restore valve function and prolong the life of prosthetic conduits, thus reducing the number of open-heart surgeries required for these patients.
According to the American Heart Association (Dallas), congenital heart defects are the No. 1 birth defect worldwide. In Canada, congenital heart defects occur in one of every 100 babies, and more than 20% of these defects involve the pulmonary valve.
Medtronic said more than 190 patients worldwide have been implanted with the Melody valve. Lee Benson, MD, an interventional cardiologist at the Hospital for Sick Children (Toronto) and Dr. Eric Horlick, at the University Health Network, Toronto General Hospital, were the first in North America to implant Melody valves under special access permission from Health Canada in 2005.
The Melody Valve and Ensemble System received CE-marking in September 2006 but are not yet available in the U.S.
Vascular Genomics Network in new research platforms
The European Vascular Genomics Network (EVGN), a Network of Excellence funded by the European Union within its 6th Framework Program, launched three platforms in 2006 representing cutting-edge tools in the field of cardiovascular science and aimed at strengthening and improving the research effectiveness of the network.
The platforms presented during the EVGN annual conference, held in Toulouse, France, in December, include:
• The Zebrafish platform, named for a versatile model organism in modern molecular biology. The platform intends to provide EVGN scientists with access to the Zebrafish model system for in vivo studies of cardiovascular development and disease. Led by EVGN scientist Marina Mione, the platform is based at the FIRC Institute of Molecular Oncology (Milan, Italy).
• The bioinformatics platform, which will provide EVGN researchers with a comprehensive set of software and web tools for storing, accessing, analyzing and elaborating the huge amount of data that comes from today’s high-throughput technologies —in particular, gene and protein expression data. The platform is managed by Anton Horrevoets of the Academisch Medisch Centrum at the University of Amsterdam (Amsterdam, the Netherlands).
• An innovative proteomics platform to perform advanced studies on structure and function of the proteins involved in the process of formation and development of cardiovascular disease. The platform is managed by Manuel Mayr of the St. George’s Hospital Medical School (London). The aim of proteomics in this field is to carry out large-scale studies of gene expression at the protein level, providing the basis for a detailed understanding of pathophysiological mechanisms and leading to the discovery of potential targets for drug development.
EVGN, which was launched in 2004, will be active until the end of 2008. Its membership includes 25 scientific institutions and three companies from 10 different European countries.
Canadian OK for Zoll in-hospital unit R series
Resuscitation device maker Zoll Medical (Chelmsford, Massachusetts) reported last month that it received a Medical Device License from Health Canada for its R Series, which Zoll said is the first and only “Code-Ready” defibrillator that can help improve in-hospital resuscitation efforts.
The license provides the necessary approval for Canadian marketing and sale of the device.
Richard Packer, president/CEO of Zoll, said, “We define ‘Code-Ready’ as a device that is simple and always ready to use. The R Series offers a OneStep system that simplifies and speeds up deployment of pacing and defibrillation therapy. It also offers comprehensive, automated readiness checks designed to maximize the readiness of the R Series to help clinicians when they need it most.”
The company said the R Series also offers tools to help clinicians with CPR performance, “which is important because more than half of in-hospital codes involve non-shockable rhythms and, in such cases, the only treatment for these rhythms is high-quality CPR with minimal interruptions.”
The R Series also offers See-Thru CPR functionality that helps clinicians reduce interruptions. While clinicians are viewing the ECG on a monitor/defibrillator, artifact (i.e., “noise”) from manual chest compressions makes it difficult to discern the presence of an organized heart rhythm unless compressions are halted. See-Thru CPR filters out this artifact so that clinicians can view an underlying rhythm without stopping chest compressions.
A visual aid known as the CPR Index allows clinicians to see how well they are performing the rate and depth of chest compressions in real time. This index, along with optional audible prompts such as “Push Harder” and “Good Compressions,” helps clinicians improve CPR performance by integrating rate and depth into a single indicator, Zoll said. With such feedback, clinicians know how well they are performing compressions and can quickly adjust their compressions to improve blood flow.
All CPR performance data and the entire resuscitation record, including the ECG, can be downloaded into Zoll CodeNet and reviewed for quality assurance and training purposes. Zoll said CodeNet is the first system to help document, review and manage a complete set of data for in-hospital resuscitation events, including both code-event data and defibrillator data, on one synchronized timeline.
The R Series also checks more than 40 measures of readiness, including the presence of the correct cables and electrodes, the type of electrode and other important electronics.
Harvest to begin trial with BMAC in Berlin
Harvest Technologies (Plymouth, Massachusetts) last month reported that Berthold Amann, MD, a specialist in vascular medicine, has received approval to begin a 90-patient clinical trial at the Vascular Center of Franziskus Hospital (Berlin) using Harvest’s Bone Marrow Autologous Concentrate (BMAC) device for concentrating autologous bone marrow stem cells to treat patients with end-stage critical limb ischemia (CLI) who face leg amputation.
In a pilot study by Amann, 23 end-stage CLI patients with ischemic legs that were threatened by amputation were injected with their own bone marrow stem cells. Sixteen (70%) of these patients were able to have their limbs salvaged and their CLI disease arrested as a result of the stem cell therapy, according to Amann.
Amann reported that concentrating bone marrow with the Harvest BMAC system made the procedure a simple, 15-minute bedside protocol and eliminated the risks of contaminating the sample or damaging the cells by sending the bone marrow to a laboratory.
Harvest says its BMAC system is the only technique that produces clinically significant amounts of stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes. Injected autologous adult stem cell concentrates from bone marrow have been shown to be significantly effective in achieving tissue regeneration in vascular, orthopedic and cardiovascular disease.
France accepts smoking ban, enforces Evin Law
The love affair between the French and their cigarettes is over. A separation was made official in 1992 with passage of the Evin Law, but the divorce didn't happen. The French continued to live with cigarettes until earlier this month when the government finally began enforcing the law.
Cafés, bistros and brasseries have one year to prepare for a total no-smoking ban scheduled to go into effect on Jan. 1, 2008.
More remarkable than the sudden courage of the government to enforce the 14-year-old law was the calm response in Paris — no demonstrations, the country did not shut down. The only sign of the change on the streets were unusual numbers clustered around doorways to office buildings smoking cigarettes.
The association of tobacco retailers called for demonstrations back in November when the Health Minister Xavier Bertrand threatened to apply the Evin Law. Only 15,000 fuming participants marched in Paris on that "Day of Anger," so the minister confidently announced the next-day enforcement of the smoking ban for the first of February.
The business newspaper Les Echos congratulated France for arriving at the head of the class of non-smoking European nations, though a quick study reveals this to be Gallic bravado. The half-measures against public smoking enacted by France earn a place toward the back of the class — with the laggards.
European Health Commissioner Markos Kyprianou recently formally launched a review of the smoking prohibitions put in place by the 27 member states with the goal of publishing a “Green Paper” expected to proceed a EU-wide ban on public smoking. According to The Guardian (Manchester, UK), the commissioner takes a favorable view of a total prohibition similar to the measures taken in 2004 in Ireland, the first country to boldly ban public smoking. Norway followed six months later; Sweden followed suite in January 2005. And Luxembourg implemented a total ban this past September.
In these “abolitionist” countries, according to Les Echos, “the first results are positive,” with tobacco sales falling almost 18% in Ireland, and only 17% of Swedes smoking compared to 32% of French.
Less-restrictive smoking bans are in force in Spain, Italy, Malta, Finland, Scotland, the Czech Republic and Belgium, which joined the non-smoking Euro zone on Jan. 1.
England's health minister announced a July 1, 2007, deadline for a partial smoking ban.
The hard cases in Europe are Germany, Austria and EU commissioner Kyprianou's native Greece.
German Chancellor Angela Merkel is an advocate of the ban, a change from her predecessor, Gérard Shr der, who even took his arguments to the EU courts. But Merkel is struggling to advance even modest measures, as the federal government has no authority over smoking rules for hospitals, schools and restaurants, which will be decided by each of the 16 federated regions.
Austria is nearly pro-smoking, with 43% of the population supporting a ban. The new minister for health, Andrea Kdolsky, a physician and confirmed smoker, set off a row in Vienna recently when she said in a television interview that she opposed enforcing a ban. She later softened that position.
In Paris, the daily France Soir announced in a headline that “Resistance is Useless," predicting: “We are going to live in a perfect society, fatter, sadder and older. What joy, but Mon Dieu how boring!”
The left-leaning Liberation created a new column called “Smoking” where it suggested that as a “beau geste” of resistance, smokers should light their cigarettes in public places by the filters.
Elle magazine was upbeat, encouraging its readers to take up the UK phenomenon called “smirting,” that is smoking/flirting. The magazine reported that cigarette breaks on Ireland's sidewalk have sparked romances. Elle suggested its readers should, as a conversation starter, forget to bring their lighters.
“Who would have imagined?” asked Les Echos, that the French would greet the smoking ban with a shrug of the shoulders rather than inflamed anger? The acceptance of the smoking ban is “completely incredible in this country of rebels,” it said. All the more amazing is that the government dared to enforce a ban, “to which the French are not exactly indifferent,” at the height of a presidential campaign.