From CD&Ds

Affymetrix (Santa Clara, California) reported that the University of Ottawa Heart Institute (UOHI; Ottawa, Ontario) is using the Affymetrix Genome-Wide Human SNP (single nucleotide polymorphisms) Array 6.0 for its whole-genome association study on coronary artery disease (CAD).

The company said that over the next three years, UOHI researchers will use the array to screen the DNA of more than 12,000 individuals to confirm their previous findings and also to identify new associations that provide scientists with a better understanding of how to identify and develop personalized treatments for the causes of CAD.

With the SNP Array 6.0, researchers are able to use a single, whole-genome panel to analyze larger, multiple sample sets for both the initial scan and replication phases of an association study.

Scientists traditionally have performed initial genome scans using a high-density, whole-genome panel and then validating those results across a larger sample population with custom array technology that focused on a subset of SNPs. The whole-genome panel approach increases the overall genetic power of these studies and further accelerates the gene discovery process by enabling different groups to combine their data from different populations and disorders with overlapping phenotypes.

“Significant research underway at the UOHI will soon enable scientists to isolate, understand and target the trail of genetic activity that causes coronary artery disease, the leading killer in North America,” said Robert Roberts, MD, president/CEO of the institute. “The Affymetrix SNP Array 6.0 is making these types of studies possible today.”

In May, UOHI scientists used Affymetrix microarray technology to identify a DNA sequence associated with increased susceptibility to heart disease, by as much as 40%, regardless of other established risks such as cholesterol, blood pressure and diabetes. The team found that individuals carrying two copies of the genetic variant — about 25% of the population — had a 30% to 40% higher risk of heart disease and those carrying one copy (50% of Caucasians) have an increased risk of 15% to 20%.

The discovery could be used to identify those at high risk for heart disease and enable early preventive therapies. The results of this study were published in Science and have since been confirmed in several independent Caucasian populations around the world, the company said.

New UK stroke strategy adds £105 million for training, improved care

Under a plan to reengineer and improve stroke services in the UK, recently unveiled by Health Secretary Alan Johnson, anyone in a higher-risk group who suffers a minor stroke will receive an MRI scan within 24 hours. The strategy aims to accelerate the emergency response to stroke by setting out a framework for care for those affected by stroke and raising awareness about symptoms and risk factors.

The government has committed £105 million to provide national support for improving stroke services.

By following the actions set out in the new strategy, National Health Service officials said up to 6,800 deaths and cases of disability could be avoided every year, and another 1,600 strokes could be averted through preventive work.

Key elements of the stroke program include:

• MRI scans for higher-risk individuals with transient ischemic attacks (TIA), so-called “minor strokes.” Those scans are to be done within 24 hours of the patient experiencing stroke symptoms, within seven days for low-risk individuals. Officials said this step alone could lead to an 80% reduction in the number of people who go on to have a full stroke. Currently, less than 35% of UK healthcare providers manage to treat TIA within seven days.

• Immediate transfer of those with suspected stroke to a specialist center offering immediate clinical assessment, scans and clot-busting drugs. The plan calls for all local areas to have 24/7 coverage by at least one specialist center.

• Those with stroke requiring urgent brain imaging are to be scanned within the next scan slot during normal working hours, and within 60 minutes out of hours.

• All individuals with stroke must spend the majority of their time in a stroke unit.

• People affected by stroke and their caregivers should have immediate access to high-quality rehabilitation and support from stroke-skilled services in hospital, and the specialist care should continue for as long as it is needed.

Of the £105 million committed to improve stroke services, the development of acute and community demonstration sites to pioneer best practices will receive £77 million in funding.

Another £12 million will fund activities aimed at raising stroke awareness nationally, anto training for strokeultants, nurses and allied health professionals, includes funding for an additional 30 stroke specialist physician training posts in 2008-2009.

Four more hospitals begin training for implant of CardioWest

In late November, two Italian hospitals, one German hospitals and one from Switzerland received the first phase of certification training for implanting the CardioWest temporary Total Artificial Heart (TAH-t) made by SynCardia Systems (Tucson, Arizona).

Staff members from the four hospitals spent two days in Paris learning patient selection, blood management techniques, surgical procedures and patient recovery protocol. A total of 20 hospital staff members participated in the CardioWest certification training. The hospitals included the Heart Surgery Institute at the University (Italy), the University of Naples (Italy), Hannover Medical School (Germany), and University Hospital Bern (Switzerland).

CardioWest reported, to date, 22 TAH-t-certified centers worldwide, with nine more hospitals to participate in the certification process. CardioWest-certified centers are located in the U.S., Germany, France, Canada and Austria.

The CardioWest bills the TAH-t as the first and only FDA-, Health Canada- and CE-marked temporary total artificial heart. Originally designed as a permanent replacement heart, it is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure.

Sandvik to acquire Medtronic plant in Memphis

Sandvik Materials Technology (Sandviken, Sweden) has entered into an agreement with Medtronic (Minneapolis) concerning the acquisition of a manufacturing plant that specializes in medical instruments for spinal surgery. The plant is in Memphis, Tennessee, home of Medtronic Sofamor Danek. The acquisition is expected to be concluded this quarter.

The Memphis plant will complement Sandvik’s existing expertise and product offering, the company said. It will continue to supply Medtronic as part of a long-term supply agreement.

Sales from products produced at the facility amount to about SEK 140 million ($20 million), the number of employees there totaling 110. Through the acquisition, Sandvik said it strengthens its position in the important and rapidly expanding medical segment.

“The acquisition is in line with our long-term ambition to be a strategic partner within the medical area and a complete supplier to globally leading medical technology companies,” said Peter Gossas, president of Sandvik. “Through the acquisition of Medtronic’s Memphis plant, we extend both expertise and capacity in the field of spinal surgery, which complements our offering within the medical area.”

Sandvik is a global industrial company with products and leading positions in selected areas - tools for metal cutting, machinery and tools for rock excavation, stainless materials, special alloys, metallic and ceramic resistance materials as well as process systems.

Sandvik is a business area within the Sandvik Group and a maker of value-added products in advanced stainless materials, special alloys, metallic and ceramic resistance materials, as well as process plants.

Boston Scientific garners CE mark for Liberté use in diabetics

Boston Scientific (Natick, Massachusetts) said it has received CE-mark approval for use of its Taxus Liberté paclitaxel-eluting coronary stent system in patients with diabetes.

The company said it submitted data showing that the Taxus Liberté drug-eluting stent (DES) has benefited diabetic patients with coronary artery disease, both in clinical trials and real-world registries.

Boston Sci said this approval means the Taxus Liberté stent system now has more CE mark-approved indications than any other drug-eluting stent, allowing treatment of a wide range of patients, including many of those at high risk. It said the system is the most frequently used drug-eluting stent system in Europe.

“Achieving CE-mark approval for Taxus Liberté in patients with diabetes is an important milestone,” said David McFaul, senior VP international. “We are offering another specific solution for diabetic patients outside the U.S., who are typically at higher risk for adverse events compared to non-diabetic patients.”

Combined data from four Taxus ATLAS trials supported the efficacy and safety of the DES system in diabetic patients. The trials examined 1,529 patients treated with the Taxus Liberté stent system, 413 of whom had diabetes, and reported similar rates of target lesion revascularization (TLR, or retreatment), cardiac death, myocardial infarction and stent thrombosis (clotting) between diabetic and non-diabetic stent recipients after adjustment for differences in risk at baseline.

Boston Scientific said diabetes affects more than 200 million people worldwide and is expected to affect 360 million people by 2030. Roughly half of all patients presenting with coronary artery disease (CAD) in Europe have diabetes.

Diabetic patients with CAD often have poorer outcomes after revascularization procedures because their blood vessels tend to build up more plaque than the vessels of non-diabetic patients and their CAD advances more quickly. CAD is the most common cause of death among European adults with diabetes, according to the company’s statement.

Boston Sci said that as a result of the expanded CE mark, the Taxus Liberté stent system is indicated in the European Union for treatment of de novo and restenotic lesions or total occlusions in patients with coronary artery disease – angina, silent ischemia, acute myocardial infarction – to improve luminal diameter and reduce restenosis within the stent and at the stent edges in native coronary arteries.

The DES system also is indicated for patients with concomitant diabetes mellitus as well as treatment of abrupt or threatened closure in patients with failed interventional therapy.

The Taxus Liberté stent is available outside the U.S. in a range of sizes to treat a diversity of vessel sizes and lesion lengths seen in patients with coronary artery disease.

The system is pending FDA approval.

Newest Stereotaxis system install in French EP lab

Stereotaxis (St. Louis) reported the placement of a Stereotaxis Magnetic Navigation System in France at a new electrophysiology lab at the University Hospital of Bordeaux.

The EP lab is headed by Professors Michel Haissaguerre and Pierre Jais, whose discovery of the ectopic foci that trigger atrial fibrillation (AF) in 1998 “paved the way for new ablation techniques for more effectively treating the disease,” which affects millions of people worldwide.

“We are very enthusiastic about the present and future applications for the Stereotaxis system, which represents an engineering tour de force,” Haissaguerre said during the opening ceremonies for the new lab. “The Stereotaxis system allows stable and precise catheter positioning, potentially better than manual manipulation. Our initial experience on AF using the magnetic irrigated catheter is very promising, suggesting ... the potential for a higher safety margin in comparison with conventional manipulation while maintaining at least equivalent efficacy.”

He added: “Our next goal is to achieve complete automation of the many different techniques necessary for catheter ablation of cardiac arrhythmias and particularly AF.”

Bevil Hogg, CEO of Stereotaxis, said the installation of the Stereotaxis Niobe system in Bordeaux represents “a significant milestone for us.” He called University Hospital of Bordeaux “one of the leading research institutions in the world for electrophysiology.”

He noted that the installation includes an Odyssey Network Solution, a networked user interface that consolidates the multiple information sources and systems of a traditional EP lab into one large screen with single mouse control. That system, Hogg said, “has the potential to contribute significantly to procedure room simplification and work-flow productivity, and through its private network, to promote the dissemination of best practices worldwide.”

Saying that the irrigated catheter has now expanded to multiple sites in Europe, he said a “significant number” of cases using the irrigated catheter have now been performed, “and we are gratified to note the high success rate in terms of outcomes and patient safety.” He noted that Haissaguerre and his team “are pioneers in the discovery of new approaches to the treatment of AF.”

Lymphoseek granted patent allowance in Japan

Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said that the University of California, San Diego (UCSD) has been notified that it has received the first patent covering Lymphoseek (technetium Tc99m DTPA-mannosyl-dextran) in Japan.

Lymphoseek is a radioactive lymphatic mapping targeting agent being developed by Neoprobe for use with hand-held gamma detection devices, such as the company’s neo2000 system.

Neoprobe holds the exclusive rights to Lymphoseek, under license from UCSD, for use in diagnostic applications such as lymphatic mapping, as well as in ultrasound and optical imaging. Lymphoseek also is covered by patents previously issued to UCSD in June 2002 (U.S. patent 6,419,990) and in the European Union in November 2005.

After achieving what it termed “positive efficacy results” in recently completed Phase II multi-center clinical trials for Lymphoseek, the company said it is now moving forward with preparations for two Phase III clinical trials — one in breast cancer and one in melanoma.

Schiller interested in BSP’s HyperQ technology

Biological Signal Processing (BSP; Tel Aviv, Israel), a start-up company that develops what it terms “innovative, simple and cost-effective systems for early stage, non-invasive diagnosis and monitoring of ischemic heart disease,” said it has received a letter of intent from Schiller (Baar, Switzerland) indicating that firm’s interest in incorporating BSP’s HyperQ technology into Schiller’s products.

BSP said that after reviewing the technological and clinical evidence regarding the HyperQ technology, Schiller expressed interest in integrating the HyperQ technology, as a first step, into its stress ECG systems.

BSP said negotiations will take place regarding licensing of the stress HyperQ technology, with the intention of signing an agreement during 1Q08. The letter of understanding is non-binding, and BSP said Schiller is aware that the Israeli company is negotiating with other parties without limitations.

Dr. Amir Beker, founder and CEO of BSP, said, “We are pleased with the signed letter of intent and perceive it as a declaration of confidence in our HyperQ technology and products. This is a ... significant step, accelerating the deployment of the HyperQ technology and products into world markets.”

He added: “The incorporation of the HyperQ technology into the products of a world-leading medical device manufacturer such as Schiller will pave the way for the integration of the HyperQ technology into further applications such as rest ECG systems, implantable devices, homecare monitors and more.”

BSP is dedicated to developing risk-free and reliable solutions for the diagnosis and monitoring of ischemic heart disease. The HyperQ System for Stress Tests, BSP’s first product, has received FDA 510(k) approval and obtained the CE mark.

BSP was founded in 2000 by Beker, a graduate of the Israeli IDF Talpiot program and a researcher in the field of biomedical signal analysis in academia and industry, and Ariel Landau, formerly executive VP of Elbit Systems and Elscint.

The company completed a successful IPO in mid-2006 and is traded on the Tel Aviv Stock Exchange.

More than 3,500 patients in Israel, Europe and the U.S. have been examined by the HyperQ System in controlled clinical studies, in a clinical pilot program and in routine operation.

In addition to its headquarters in Tel Aviv, the company has U.S. offices in Rockville, Maryland.

Boston Sci gets CE mark for its rebranded Livian CRT-D device

Boston Scientific (Natick, Massachusetts) has released the next generation of its cardiac resynchronization therapy defibrillator (CRT-D) called Livian, which treats heart failure and helps protect patients at risk of sudden cardiac death. Its Gudiant subsidiary earlier developed a similar device called Contak Renewal – which faced a massive recall.

The company reported in late December, the company reported that it had received CE-mark approval for the Livian CRT-D. It is still awaiting FDA approval, however.

“The process has been started — we’ve already filed for FDA and we expect to have Livian on the U.S. market by the first half of 2008,” David Knutson, a spokesman for Boston Scientific’s Cardiac Rhythm Management Division, told Cardiovascular Devices & Drugs. “The Livian represents [Boston Scientific’s] first branded CRT-D device.”

The branding is probably the biggest difference between Livian and Contak Renewal. However, when you talk about the devices, the differences come from the key features, Knutson said. “Livian’s special features include an option to monitor heartbeats in heart failure patients and gives doctors a way to manage the patient’s progress. It represents all the work we’ve done.”

The device also delivers small electrical impulses that may improve the heart’s pumping ability. “Livian is for those patients who are facing heart failure,” Knutson said.

The Livian CRT-D, which is available in high-energy and standard-energy models, enables clinicians to customize therapy based on a patient’s individual needs. The implantable device uses Boston Scientific proprietary technology — built on years of clinical research — and is designed to improve a patient’s response to cardiac resynchronization therapy. The device also offers clinicians technology to help manage heart failure patients with frequent atrial arrhythmias.

Nearly 22 million people worldwide — including about 6.5 million in Europe — suffer from heart failure, which affects not only a patient’s quality of life, but also life expectancy. Nearly 1 million new cases of heart failure are diagnosed annually, making it the most rapidly growing cardiovascular disorder.

“This next-generation CRT-D offers physicians in Europe and elsewhere even more flexibility for tailoring therapy to each patient,” said Jim Tobin, president/CEO of Boston Scientific.

Boston Scientific has been in the business of rebranding previous Guidant devices as of late. Livian follows the Confient ICD, which is a rebranding of Guidant’s Vitality line of devices. One reason for the re-branding could be the company’s need to distance itself from the Gudiant products, which have had numerous recalls and a plethora of lawsuits.

In addition, Boston Sci has struggled with weak sales since early 2005 on its two key product lines: defibrillators and drug-coated stents. Sales of drug coated stents, metal tubes that are used to prop open arteries, have shriveled amid questions about their safety and benefits.

U.S. regulators in April lifted a quality-control warning about problems involving a Guidant plant that makes defibrillators and pacemakers — a step that enabled Boston Scientific to resume seeking approval for new devices to correct abnormal heartbeats such as Livian. However, a separate FDA warning involving Boston Scientific’s tracking of safety issues is still pending and is limiting the company’s ability to introduce other types of products.

“The coming year will be a busy year for us,” Knutson told CD&D. “We have eight to 10 products we’re going to be seeking approval for.”

Luminetx (Memphis, Tennessee) said its lead product, VeinViewer, has received CE-mark and ISO 13485:2003 certifications, allowing shipment to European countries and continuing the expansion of the Luminetx global strategy.

The VeinViewer vascular imaging system allows physicians, nurses and other healthcare professionals to clearly see accessible vasculature or a lack thereof in real time.

The device uses a combination of near-infrared light and proprietary technologies to image vascular structures and project their location directly on the surface of the skin, providing clinicians with what the company terms “a safe, non-invasive adjunct technology for clinical treatments and procedures including, but not limited to IV insertions, PICC line insertions, routine venipuncture (blood sampling), blood and plasma donations and treatment for varicose and spider veins.”

“The VeinViewer is changing the standard of compassionate care, and now with these new certifications we are able to ship [the system] to Europe,” said Mark Darty, executive VP of operations at Luminetx. “Patients around the globe will have access to this leading-edge technology and all the benefits it allows.”

He added: “This is ... the summation of tireless efforts and the judicious development of a quality program from the ground up.”

Pilot manufacturing of the VeinViewer began in spring 2006, with its FDA clearance as a Class I Exempt Medical Device granted and full U.S. commercial rollout following in the fall of last year.

More than 400 VeinViewers are currently in use, according to Luminetx.

MediGuide (Haifa, Israel) reported receiving the CE mark its Medical Position System (MPS) and MPS-enabled Guided Measurement Catheter (GMC). The MPS system is a tracking and navigation system designed to be used in various less-invasive procedures.

An MPS equipped on an X-ray imaging cath lab system is intended for intravascular evaluation of coronary anatomy. It is intended to enable real-time tip positioning and navigation of an MPS-enabled diagnostic or therapeutic invasive device used in coronary or cardiac intervention in the cath lab, on both live fluoroscopy or recorded background.

The first MPS-enabled catheter, which also received the CE mark, is the Guided Measurement Catheter. The MPS-enabled GMC intravascular device is intended to be used in conjunction with conventional X-ray angiography systems equipped with MPS — to enable real-time tip positioning and navigation, quantitative length measurement, 3-D lumen reconstruction, qualitative 3-D foreshortening indication and landmarking — in patients who are candidates for coronary angiography and/or percutaneous coronary intervention.

MediGuide was established in 2001 as a spin-off of Israeli defense technology company Elbit System (Haifa, Israel).

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