Bus Medical (Stoughton, Massachusetts) last month reported receiving the CE mark for its Endo-Ease Advantage and Endo-Ease Vista products for colonoscopy and said it is planning for the launch of the products in Europe.
The company said the two products leverage its Endoluminal Advancement System (EAS), used in conjunction with a conventional colonoscope to aid advancement through the colon with the ease of rotation. Spirus said the EAS system uses a soft spiral component fixed on an active, flexible overtube to facilitate a more efficient approach to colonoscopy. The shorter Endo-Ease Advantage is designed to aid advancement of a colonoscope through the tortuous sigmoid colon, which often cause physicians the most difficulty. Once the sigmoid colon has been traversed, the scope is unlocked from the device, and the Endo-Ease Advantage then remains in place to stabilize the sigmoid colon while the scope is advanced traditionally through the rest of the colon to complete the procedure.
The Endo-Ease Vista is a longer version designed to enable rotational advancement of the scope beyond the sigmoid colon. The Vista also provides a stable conduit through which a colonoscope can be passed to complete a colonoscopy.
“Both Endo-Ease Advantage and Vista have been extremely well received by gastroenterologists and surgeons in the U.S., and we are now positioning ourselves to market the Endoluminal Advancement System across Europe,” said Steven Tallarida, president/CEO of Spirus. The company said the Endo-Ease products “attach easily onto a slim or pediatric colonoscope.” It added that Endo-Ease Advantage and Endo-Ease Vista could help move the colonoscope through the colon “and also provide a conduit through which the scope can be advanced.”
Other products in the Spirus pipeline include the Endo-Ease Discovery SB for small-bowel enteroscopy and the Uro-Ease family of products for urology.
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Abiomed wins CE markingfor iPulse consoleplatform, IAB
Abiomed (Danvers, Massachusetts) reported receiving the CE mark for its intra-aortic balloon (IAB) and iPulse console platform. The approval allows the new combination console and disposable balloon to be sold in all European Union countries and also many other countries worldwide that accept the CE mark for registration.
The company describes the IAB as “an easy-to-insert, minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function.” The iPulse combination console platform drives Biome’s IAB, BVS 5000 and AB5000 circulatory support systems, as well as new product introductions planned by Abiomed in the future. It also is designed to be compatible with other original equipment manufacturers’ balloons.
The technology is intended to provide circulatory support for patients suffering from acute or sudden cardiovascular failure. In many countries outside the U.S., the iPulse platform will provide short-term and longer-term support, including bridge to transplant.
Abiomed’s IAB was recently cleared by the FDA, capping more than two years of internal R&D activity. The 8 Fr device is inserted percutaneously into a patient’s descending aorta and inflates and then deflates in counterpulsation to a patient’s heart rhythm.
The company said the IAB was subjected to “extensive reliability testing,” and successfully demonstrated a life of more than 8 million cycles, which equates to more than 90 days of continuous operation.
Abiomed said it expects to begin shipping its integrated iPulse console outside the U.S. during the company’s fiscal fourth quarter, ending March 31.
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Vascular Genomics Network launches new researchplatforms
The European Vascular Genomics Network (EVGN), a Network of Excellence funded by the European Union within its 6th Framework Program, has 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, 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 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.
• A proteomics platform to perform advanced studies on structure and function of the proteins involved in the process of formation and development of cardiovascular disease. This platform is managed by Manuel Mayr of 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 an understanding of pathophysiological mechanisms and leading to the discovery of potential targets for drug development.
EVGN, launched in 2004, will be active until the end of 2008. The plan is for its legacy to be taken on by new specific projects to be activated during the 7th Framework Program.
Cardiovascular diseases (CVDs) rank higher than in the past in the priorities of the national health systems of the EU. They account for more deaths than cancer. Every year the consequences of CVDs, such as myocardial infarction and strokes, kill some 5 million people in Europe and costs more than $500 billion in healthcare expenses and loss of productivity among those who survive.
EVGN’s membership includes 25 scientific institutions and three companies from 10 different European countries.
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Zoll Medical wins Canadian approval for R Seriesin-hospital unit
Resuscitation device maker Zoll Medical (Chelmsford, Massachusetts) reported 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.
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Cinvention, Relisys extend matrixstent deal
Cinvention (Wiesbaden, Germany) last month reported extension of a license and supply agreement with Relisys Medical (Hyderabad, India) for the manufacture, marketing and sale of a non-eluting coronary stent with a bioactive nano-structured carbon-composite coating with pro-healing properties. The Relisys Cobalt-Chromium Stent is coated with a porous carbon/carbon composite nano-structured matrix with a surface design for improved endothelialization.
Dr. Krishna Reddy, chairman of Relisys, said this version of a coronary stent has the potential to overcome concerns identified with current drug-eluting stents (DES). He said the animal study results at Cardiovascular Research Institute (Washington), published in April, indicate that the bioactive nano-porous carbon coating, that has no polymer, might address the issues of endothelialization, thrombosis, and continuing inflammation, the issues of concern with current polymer-based DES.
The coating has been developed by Cinvention —formerly Blue Membranes — which specializes in materials and surface engineering for biomedical applications. The Cinvention coating eliminates the use of polymers and provides a bioactive surface with less thrombogeneity and pro-endothelialization properties, thus reducing tissue inflammation and reaction, but enhancing engraftment, according to the company.
N.G. Badari Narayan, managing director of Relisys, said additional animal studies to validate the coating are ongoing. Narayan also said Relisys will focus on receiving the CE mark for its non-eluting stent this year and is targeting eventual FDA approval. The next step will be a multi-center clinical trial with 15 international centers to evaluate both non-eluting as well as the DES devices of Relisys.
Cinvention’s portfolio of nano-composite systems includes: drug delivery coatings; multi-functional device coatings; advanced carrier systems for bio-processing; tissue engineered biomaterials; and carbon/ceramic and mixed matrix membranes.
Relisys makes DES, angiographic/angioplasty catheters, occlusive devices, cardiac surgery disposables and other critical care products.
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Cellectis files for IPOon Paris Euronextstock exchange
Cellectis (Romainville, France) has filed a preliminary prospectus with the French Financial Markets Authority for launch of an initial public offering on the Alternext market of the Paris Euronext stock exchange.
Cellectis is a genome engineering company that uses a technology centered around meganucleases, which it describes as a sort of “molecular scissors” consisting of sequence-specific endonucleases with large recognition sites that permit very accurate editing of genetic sequences. Cellectis is developing meganuclease recombination systems (MRS) that combine these molecular scissors with a DNA matrix, making it possible to target a particular gene and modify it in vivo through the cell’s natural maintenance and repair system without damaging the rest of the genome.
The company says that by developing this technology on an industrial scale it can, for the first time, insert, modify, modulate or correct, in vivo, a gene in any living organism with great accuracy and reliability and without the adjunction of foreign genes that are often insufficiently specific and poorly tolerated.
The company says it currently has eight MRSs in development.
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Sartorius buys medical/biotechplastic manufacturer Toha Plast
Sartorius (Goettingen, Germany), a laboratory and process equipment provider, last month reported acquiring all shares in Toha Plast (Goettingen), a manufacturer of plastic components for the medical and biotech industries. The companies said they were keeping the deal terms confidential.
Sartorius noted that Toha has been its long-term development partner in plastics technology, including processing of thermoplastics and injection molding. The company has some 75 employees at Goettingen and modern clean room production. In July 2006, Sartorius bought “a relatively small” Toha Plast production facility in Puerto Rico.
Sartorius said that the purchase enables its Biotechnology Division to expand its expertise in the field of plastics. Injection-molded and thermoplastic components are integrated into all disposables supplied by this division in, for instance, filters, disposable bioreactors and disposable fluid handling bags for the pharma industry.
The Sartorius Group, founded in 1870, employs about 3,750. Its biotech segment focuses on filtration and separation products as well as fermenters and bioreactors. The mechatronics segment manufactures equipment and systems, which feature weighing, measurement and automation technology for laboratory and industrial applications. Sartorius has production facilities in Europe, Asia and America, as well as sales subsidiaries and local commercial agencies in more than 110 countries.
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Sequenom, Qiagen collaborateon fetal diagnostics program
Sequenom (San Diego) last month reported a collaboration with Qiagen (Venlo, the Netherlands), a wholly owned subsidiary of Qiagen NV (Venlo), to jointly develop a “gold standard” preanalytical solution for small-molecule (fetal) DNA enrichment for prenatal diagnostics.
Sequenom will retain exclusive distribution rights to the technology for enriching short nucleic acids developed under the collaboration.
The companies said the collaboration would combine Qiagen’s expertise in preanalytical sample preparation technologies in molecular diagnostics with Sequenom’s capabilities in genetic analysis technology.
The goal of the collaboration is to develop what Sequenom termed “a robust and reliable set of reagents that optimize the enrichment of small nucleic acid fragments, such as circulating free fetal nucleic acids in maternal plasma or serum, as well as short nucleic acids in blood, plasma or serum, for the analysis of cancer and other key disorders.”
The reagents are expected to provide complete and validated preanalytical solutions for research use with compatibility for potential future use in conjunction with in vitro diagnostics.
Fetal DNA enrichment is the process of increasing the concentration of fetal DNA relative to maternal DNA from blood plasma or serum obtained from a simple blood draw from a pregnant woman. The companies call robust fetal DNA enrichment “a key step” for enabling certain non-invasive prenatal diagnostics. While robust enrichment of fetal DNA is not necessary for many non-invasive prenatal nucleic acid tests such as tests for Rhesus D incompatibility, Sequenom said it is required for quantitative genomic tests such as tests for Down syndrome, cystic fibrosis and other phenotypes, conditions or disease states.
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1st implant in Zurich launches Promus DES forBoston Scientific
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 stent was designed and is made by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies announced last year.
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 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.
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European Union funds pro-angiogenesis agents
The European Union is giving a grant of 12 million ($2.6 million) to a consortium developing a new class of pro-angiogenesis agents.
The Vasoplus consortium includes Roche Diagnostics (Basel, Switzerland), Geymonat (Catania, Italy), ThromboGenics (Leuven, Belgium) and Eurogentec (Seraing, Belgium).
The money, from the EU’s research support program, will contribute over the next two years to further development of placental growth factor (PlGF) and analogues of this pro-angiogenic cytokine for treatment of ischemic heart disease, peripheral arterial occlusive disease (PAOD), tissue regeneration and wound healing.
The growth factor is a homologue of vascular endothelial growth factor, but interacts with receptors with greater specificity. In vivo toxicology and safety pharmacology studies completed by ThromboGenics and Geymonat show it to be well-tolerated, even at doses much higher than needed for efficacy.