A BB&T Staff Report

NICO (Indianapolis) reported at the American Association of Neurological Society (AANS; Rollling Meadows, Illinois) annual meeting in Denver last month that it has received CE mark approval for its automated minimally invasive brain tumor removal device, the NICO Myriad. The approval allows NICO to sell the Myriad system in the 27 countries that make up the European Union. The device has been commercially available in the U.S. since 2009 with more than 1,000 procedures performed with adults and children, sometimes in cases that would have previously been considered inoperable.

“The CE mark approval for the Myriad in Europe is a significant accomplishment that validates the impressive clinical and patient results that have been achieved throughout the U.S.,“ said Jim Pearson, president/CEO of NICO. “This device is pushing the frontier of progressing minimally invasive neurosurgery. The Myriad is allowing neurosurgeons to advance corridor surgery by providing improved access to tumors and shortening surgical resection times that result in shorter patient recovery times and hospital length of stays. It can provide the opportunity to significantly reduce patient trauma by reaching tumors located deep within the brain through much smaller openings.“

The Myriad is about the size of a pencil and is completely automated, making it the first device that operates in open and endoscopic surgical approaches without using a heat source or ultrasonic energy that can potentially damage delicate critical structures in the brain. Its slender design and malleable tip allow surgeons to operate through narrow surgical corridors to aggressively remove large masses or highly fibrotic tissue, or work with precision to remove difficult to reach tumors that may be located near or on top of structures like optic nerves and carotid arteries.

The Myriad is also able to collect tissue removed during the surgical process in a viable (intact) format. This is significant because it can be sent for pathological and oncological evaluation to determine post-surgical therapeutic treatment regimens that improve patient outcomes.

The company said that more than 200,000 people in the U.S. and 2 million people worldwide are diagnosed with a brain tumor every year. They are the leading cause of solid tumor cancer deaths in children under the age of 20, the second leading cause of cancer deaths in male adults ages 20-29, and the fifth leading cause of cancer deaths in females ages 20-29.

Volcano cleared to market PrimeWire in Japan

Volcano (San Diego) said in April it has received clearance to market the PrimeWire Prestige pressure guide wire in Japan. In addition to accurately measuring intravascular pressure via Fractional Flow Reserve (FFR), the device is designed to deliver superior handling with a frontline tip design, enhanced torque and more support.

“Japanese physicians are global leaders in advanced guide wire techniques and truly appreciate a wire that handles well in complex patient anatomy,“ said Junichi Osawa, president and managing director of Volcano Japan. “Reduced coil spacing at the tip of the PrimeWire Prestige pressure guide wire improves tactile feel of the wire, allowing physicians to maneuver the wire easily. Physicians in the U.S. and Europe have strongly embraced the PrimeWire Prestige pressure guide wire because of its handling.“

The device has a 90% improvement in torque compared to the SmartWire II pressure guide wire. A larger core wire and SlyDx coating enabled improved trackability and smooth device delivery over the wire. Full market release of the device in Japan is expected in 2Q11.

IRIS, Fujirebio ink Japanese development accord

IRIS International (Chatsworth, California), a manufacturer of automated in vitro diagnostics systems and consumables, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, said last month it has entered into a joint development agreement with Fujirebio (Tokyo), one of the largest in vitro diagnostics companies in Japan, for the co-development of the IRIS 3GEMS hematology analyzer product line.

Fujirebio will contribute $6 million toward the costs of the program, with an initial payment of $500,000 upon signing of the agreement and the balance to be paid in installments during the course of the development period based upon the achievement of certain milestones. These funds will be utilized to accelerate the 3GEMs Hematology development program, which leverages IRIS's proprietary image-based technology to automate the identification and characterization of blood cells, including an image-based expanded white blood cell differential, and is expected to significantly reduce the need for manual slide preparation and reviews.

“We are delighted with this expansion of our relationship with Fujirebio, which is currently our exclusive distributor in Japan for IRIS's series of automated urine microscopy and chemistry analyzers,“ said César García, chairman, president/CEO of IRIS. “The extension into hematology of IRIS's core expertise in automated flow imaging technology and particle recognition represents a significant opportunity and we are pleased that Fujirebio has committed to partnering with us.“

Vermillion's OVA1 to be available in India

Vermillion (Austin, Texas), a molecular diagnostics company, reported in April that it has signed an agreement with Quest Diagnostics (Madison, New Jersey) to make OVA1 available in India. The companies are targeting a launch in 2Q11.

OVA1 is the first protein-based in vitro diagnostic multi-variate index assay (IVDMIA), a new class of state of the art software-based diagnostics, cleared by the FDA. The test utilizes five well-established biomarkers – Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) – and proprietary software to determine the likelihood of malignancy in women with an ovarian mass for whom surgery is planned.

Spectranetics LLD granted Japanese approval

Spectranetics (Colorado Springs, Colorado) reported that the Japanese Ministry of Health, Labor and Welfare (MHLW) granted approval for the LLD lead locking device, which is used for the removal of pacemaker and defibrillator cardiac leads. The LLD secures leads along the entire length of their hollow inner lumen, permitting physicians to apply steady traction on the lead during the removal process.

The approval of LLD complements the prior product and hospital reimbursement approvals in Japan for the Spectranetics Laser Sheath (SLS II).

This technology has been used in the U.S. and Europe for more than a decade and is an important tool to manage lead-related issues, such as infection, malfunction, and venous occlusion that may arise in the over 5 million pacing and defibrillation leads implanted in patients worldwide. The LLD has the unique capability to lock leads along their entire length as well as the unique ability to be unlocked and repositioned within the lead.

“Japan represents an important market for Spectranetics and the LLD approval is a key milestone in our commercialization efforts in Japan, supported by our distribution partner, DVx,“ said Shar Matin, senior VP of operations, product development, and international. “Our next objective is to obtain reimbursement from the MHLW for the LLD. We also look forward to additional vascular intervention product approvals in Japan later this year.“

Wellcome gives GE Healthcare research award

The Wellcome Trust (London) has awarded a Strategic Translation Award to GE Healthcare (Chalfont, UK) for research into the potential use of MRI for newborns at high risk of brain injury. This marks the first time GE Healthcare will collaborate with Wellcome Trust to extend the reach of MRI technology.

Ultrasound technology is most commonly used to image newborns that are at high risk of developing brain injury, largely because the technique can be performed within the Neonatal Unit at the hospital. MRI is widely accepted as being a better diagnostic tool; however in many centers it is not practical to take babies to an MRI scanner, which is usually located in another part of the hospital or sometimes at another center As a result, the risk of removing a baby from the protective environment of the Neonatal Intensive Care Unit usually outweighs the potential benefit to be gained from MRI as a more sensitive imaging technique.

The Wellcome Trust award will initially be used to investigate how MRI could be placed within the neonatal unit itself, removing the need to transfer the infant. This research will lead to a better understanding of the technology required to care for infants in a Neonatal Intensive Care environment.

Delcath gets CE mark for Hepatic Chemostat

Delcath Systems (New York) said last month it has been notified of CE mark approval for its Hepatic Chemostat delivery system. The product has been approved with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.

Delcath is a specialty pharmaceutical and device company focused on oncology. Its initial focus is on the treatment of primary and metastatic liver cancers.

XDx reports CE mark for AlloMap test

XDx (Brisbane, California), a molecular diagnostics company focused on developing noninvasive gene expression tests to monitor immune-mediated conditions, reported in April that its AlloMap molecular expression test has been CE marked under the In Vitro Diagnostics Directive.

AlloMap is a noninvasive FDA-cleared test that has been on the market in the U.S. since January 2005. It provides transplant physicians with a tool to aid in the determination of the probability of acute cellular rejection for post-cardiac transplant patient management.

AlloMap's CE marking is a critical accomplishment for XDx in its strategy to make AlloMap available to heart transplant patients and healthcare practitioners in the EU, and eventually in other markets around the world, the company said. The potential EU market for heart transplant surveillance monitoring is substantial and nearly identical in size to the U.S. market, with nearly 2,000 new heart transplants performed annually and 20,000 living heart transplant recipients.

Scientists developing new Down syndrome test

At the moment, the only reliable way of diagnosing chromosomal irregularities during pregnancy is to use invasive prenatal methods. This causes miscarriage in about 1% of these risky surgical procedures.

Scientists from the Center for Prenatal Diagnosis and Human Genetics, Kudamm-199 (Berlin), have been working with scientists from GATC Biotech (Konstanz, Germany) and LifeCodexx (Konstanz, Germany) to develop a non-invasive diagnostic test based on sequencing which reliably detects a fetal trisomy 21 (Down syndrome). The test is based on the sequencing of cell free fetal DNA from the maternal blood, and in the foreseeable future it could become a no-risk alternative to the invasive prenatal examinations such as the analysis of amniotic fluid (amniocentesis) which are currently used.

“Prenatal diagnostics with multiplex sequencing are still very expensive. In order to drastically reduce costs in the near future, we are in the process of developing a method which allows the pooling of several samples for parallel analysis with the Illumina HiSeq2000 sequencing system,“ said Peter Pohl, CEO of GATC Biotech and head of the supervisory board of LifeCodexx.

Reverse receives CE mark for ReFlex A+ catheter

Reverse Medical (Irvine, California) reported in April that it has received the CE mark for its ReFlex A+ catheter for intracranial distal access, delivery and aspiration. The catheter is designed to provide endovascular intracranial access during interventional neurovascular procedures.

The ReFlex A+ catheter is approved for 4, 5 and 6 French sizes, with straight and multi purpose curve tip configurations. The company said it plans to immediately begin European and Asian commercialization through prominent international distributors, in territories that recognize the CE mark.

Scottish court upholds Verathon patent

Verathon (Bothell, Washington) reported last month that a Scottish court has upheld its European Patent for the GlideScope video laryngoscope.

During recent court proceedings against Aircraft Medical (Edinburgh, Scotland), a firm that produces the McGrath laryngoscope, Lord Hodge of the Scottish Court of Session recognized the validity of the GlideScope patent.

Introduced in 2001, the GlideScope video laryngoscope provides a consistently clear view enabling quick intubation. Designed for 1st Pass Success, the brand has grown rapidly and now incorporates models for patients ranging from preterm/neonatal to bariatric, and offerings that span single use and reusable configurations.

Scientia wins CE mark for Plato microcatheter

Scientia Vascular (Reno, Nevada) reported in April that its Plato microcatheter has received CE mark approval, facilitating availability for European neuro, cardio and peripheral endovascular applications.

Engineered with breakthrough microfabrication technology, Plato microcatheters provide excellent trackability and distal access. Plato also offers a stable platform for delivery of therapeutic implants, such as detachable coils and stents, Scientia noted.

The Plato microcatheter design features a proximal stainless steel hypotube, with 1:1 push response, and a proprietary microfabricated polymer distal shaft. The hypotube is placed into the guiding catheter, from which the distal shaft exits to be placed into distal anatomy for precise control at the site of therapy. Plato is available in straight and pre-shaped, one- and two-tip marker configurations to allow access and stability in various anatomical locations and morphologies. Catheter tips may also be steam-shaped for specific physician needs.

Abbott introduces Hepatitis B sequencing test

Abbott Molecular (Des Plaines, Illinois) reported last month that it has received CE marking for its HBV Sequencing test. This molecular diagnostic test, developed to identify genomic sequences of the hepatitis B virus (HBV) and help physicians monitor HBV infections, guide treatment decisions, and predict or discover drug resistance, is the first DNA sequencing assay developed by Abbott Molecular.

The CE-marked HBV Sequencing test identifies the DNA sequence of the HBV polymerase gene including all clinically relevant HBV drug resistant mutations. The test is not intended for screening blood donors, plasma or tissue donors for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.

HBV is classified into eight separate genotypes (labeled A-H). HBV genotype is a prognostic indicator because it correlates with disease severity and response to interferon therapy. For example, genotype C is prevalent in Asia and associated with more severe liver disease and development of liver cancer. In contrast, genotype B (also prevalent in Asia) has a better prognosis and is rarely associated with progression to liver cancer. Also, patients with HBV genotypes A and B seem to respond better to interferon therapy than those with genotypes C and D.

Abbott noted that significant progress has occurred in recent years in developing antiviral therapies for HBV. Several anti-polymerase drugs are available worldwide. The new HBV Sequencing assay can be used in tandem with Abbott's RealTime HBV viral load assay to monitor the efficacy of HBV treatments.