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When plaque builds in the carotid arteries, surgeons step in to perform an endarterectomy, angioplasty or stenting to prevent patients from having a stroke. But the procedure itself is tricky and sometimes a piece of the plaque can break away and reach the brain, causing a stroke. W. L. Gore & Associates (Flagstaff, Arizona) received FDA approval last month for a device that reverses the flow of blood during stenting procedures, offering a level of protection unavailable before.

"The Gore Flow Reversal System is really a game-changer in terms of neuroprotection," Stuart Broyles, PhD, Stroke Interventions Business Unit leader at Gore, told Biomedical Business & Technology. The Gore Flow Reversal System is neuroprotection technology that literally reverses the flow of blood at the treatment site prior to crossing the lesion so there's almost no chance that particles could escape to the brain.

"The current standard relies on continuous normal blood flow where debris that's released from the lesion is captured upstream or closer to the brain in a mechanical filter," Broyles said. "In our case, we're flushing blood in the opposite direction of normal flow passed the lesion to flow down the balloon sheath to be filtered outside the body."

Flow reversal is achieved by selectively blocking the common carotid and external carotid artery blood flow. After establishing an arteriovenous shunt, blood from collateral vessels via the Circle of Willis is redirected to the lower pressure venous return. Embolic plaque debris are then continuously directed away from the brain during flow reversal.

"The hypothesis, which our clinical data support, is that the reversal of flow mitigates risk of particles making it passed the distally placed filter and reaching the brain," Broyles said. "It also means that we can establish flow reversal before you have to interact with the lesion you're dealing with. You don't have to worry about knocking off some of the plaque before the patient is protected."

Embolic filters commonly used as the primary neuroprotection device must go across the lesion, leaving the patient unprotected and vulnerable during the procedure. Broyles said there is currently no other product on the market that uses continuous flow reversal.

Daniel Clair, MD, of the Cleveland Clinic Foundation (Cleveland) and national co-principal investigator for the Gore EMPiRE clinical study, said that the Gore Flow Reversal System may help to establish carotid stenting as the therapy of choice for a greater number of patients.

The EMPiRE study met the primary endpoint of major adverse events of death, stroke, transient ischemic attack and myocardial infarction. The 30-day stroke death, and MI rate was 3.7% and the death / any stroke rate was 2.9%.

Gore also reported FDA approval of a modified version of the Gore TAG Thoracic Endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The original Gore TAG was approved in 2005 (MDD, March 25, 2005) as the first endovascular grafting system approved in the U.S. to treat TAA.

Elsewhere in the product pipeline:

• Cape Cod Clinical Research (Osterville, Massachusetts) reported the launch of TrialDOCS, an online clinical document management tool. The company says that the capabilities of TrialDOCS will assist pharmaceutical and biotech companies in managing their regulatory documentation electronically across multiple US and international sites. TrialDOCS will enable investigative sites, site monitors, and pharmaceutical companies to view and manage their regulatory files via a secure website.

• Cleveland Medical Devices (Cleveland) has launched a large-scale multicenter clinical study to continue development and validation of Kinesia, a compact wireless system for monitoring severity of Parkinson's disease (PD) motor symptoms. Kinesia uses miniature motion sensors worn on the hand and wirelessly transmits motor symptom information to a PC. Data is collected while patients follow computer-based video instructions which guide them through various arm and hand movements. In the study, Kinesia will be used to quantify symptoms including tremor, bradykinesia (slowed movements) and dyskinesias (wild involuntary movements) in the clinic and at patients' homes. Data collected during the study will be used to validate existing Kinesia algorithms for automated tremor scoring as well as aid in development of new algorithms for automated bradykinesia and dyskinesia scoring.

• Compugen (Tel Aviv, Israel) reported the discovery and experimental verification of CGEN-327, a novel molecular biomarker candidate for the diagnosis of ovarian cancer. CGEN-327 is a previously unknown splice variant of the HE4 (Human Epididymis Protein 4) gene, which is a known biomarker for ovarian cancer. The company also said that it has entered into a research and license option agreement for the product candidate with an unidentified diagnostic company. Patent coverage for this discovery is being pursued by Compugen.

• Covidien (Boulder, Colorado) reported the introduction of the Mallinckrodt SealGuard Evac endotracheal tube. The SealGuard Evac tube uses a tapered-shape cuff made from an ultrathin material that virtually eliminates microaspiration of secretions into the lungs while providing secretion drainage through an integrated suction lumen. The new design and technology have been clinically demonstrated to reduce the incidence of both early- and late-onset ventilator-associated pneumonia (VAP), an important breakthrough for long-term intubation. Subglottic secretions drainage performed with the SealGuard Evac tube has been shown to reduce VAP by up to 75%. Covidien says the SealGuard Evac tube's cuff reduces microaspiration by at least 95%, compared with current high-volume, low-pressure cuffs, reducing the risk for complications associated with aspiration.

• Diagnosoft (Morrisville, North Carolina) reported its newest software solution, Diagnosoft SENC. Strain-encoding, or SENC, is a new MRI analysis technique that will help physicians measure regional contraction, or relaxation, of the heart's myocardium. Diagnosoft SENC enables quantification of data to improve diagnosis and guide monitoring and treatment of coronary artery disease. Most cardiac MRI procedures require patients to hold their breath. However, SENC images can be acquired in a fraction of a second, mapping regional function with unprecedented speed, so it can be used in combination with tests and maneuvers that allow patients to breathe normally. That means SENC is suitable for stress testing of cardiac function, as well as other diagnostic tests.

• EaglePicher Medical Power (Joplin, Missouri), a supplier of batteries for implantable medical devices, reported the availability of two new, mini, Lithium-ion batteries developed to meet a growing demand for smaller, longer lasting, implantable medical devices. The two D-shaped Li-ion batteries, which each weigh under 2.3 and 3 grams (less than a small watch battery), provide capacity of more than 50mAh and 60mAh respectively. They join the EaglePicher Contego modular battery line, which is now compromised of five cells ranging in size from 0.5mAh to 350mAh.

• Edwards Lifesciences (Irvine, California) said it is launching the Carpentier-Edwards Physio II mitral valve repair ring. The new therapy represents the next generation of the Carpentier-Edwards Physio ring, which the company said is the market-leading heart valve repair device. Edwards says the Carpentier-Edwards Physio II ring is a novel mitral valve repair solution. It is the only annuloplasty ring offering "shape optimization," which matches the geometry of the ring to the characteristics of the patient's diseased mitral valve, and does not limit repair options based on etiology, or cause, of the mitral valve disease. Several new features, such as a unique sewing cuff, provide surgeons with a device that is also easier to implant.

• Evalve (Menlo Park, California) reported the start of enrollment in the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip System) study, a continued access registry. The MitraClip system is currently being evaluated in the U.S. as a non-surgical treatment option for patients suffering from the effects of mitral regurgitation (MR). Percutaneous mitral repair with Evalve's MitraClip system is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip therapy may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

• Helicos BioSciences (Cambridge, Massachusetts) reported significant improvements in the performance of the Helicos genetic analysis system, available immediately for customers. With these improvements, the system is generating 20 to 30 gigabases (GB) of high-quality sequence data per run, an output equivalent to the sequencing of 7 to 10 human genomes per run. Proof of the system's performance was demonstrated recently by sequencing the 104MB genome of the nematode C. elegans at 27-fold coverage (~2.8 GB of sequence) using just 7 of the 50 channels of a single run on a HeliScope Single Molecule Sequencer. Consensus accuracy above 5-fold coverage was 99.999%, or 1 error in 100,000 bases, which resulted in the identification of hundreds of single nucleotide substitution polymorphisms in the strain sequenced.

• Labcyte (Sunnyvale, California) reported the introduction of the new Deerac Q which integrates two liquid-handling systems into a single platform for preparing low-volume genomic assays. By combining the Deerac magnetic feedback control dispensing technology with a 96-channel pipettor with disposable tips, the Deerac Q saves time, reduces process risks, and eliminates the need to transfer plates between workstations.

• Masimo (Irvine, California) reported that a new multi-center study of 39,821 newborns was published in the January issue of the British Medical Journal. When compared to a cohort group of 108,604 newborns in whom no pulse oximetry screening was used, the study found that the addition of Masimo SET pulse oximetry screening before discharge increased detection of congenital heart disease (CHD) by 28% (from 72% to 92%). The researchers concluded that Masimo pulse oximetry screening of "all well babies in maternity units is practically feasible with a minimum use of nursing time" and that it "significantly improves" detection of duct dependent CHD.

• Medgenics (Misgav, Israel) said that the Epodure Biopump, the company's tissue-based technology, has successfully demonstrated safety and efficacy for the sustained protein therapy of anemia in patients with chronic kidney disease. In the company's ongoing Phase I/II clinical trial, a one-time administration of Epodure, producing and delivering the low dose of 18-25 IU/kg/day of the protein erythropoietin (EPO), was sufficient to sustain therapeutic elevation of hemoglobin in most patients. The earliest patients to receive treatment have shown sustained hemoglobin within the target range for four months without receiving any EPO injections. By contrast, in standard practice today, EPO injections are required up to several times per week, and the comparable low dose does not result in sufficient hemoglobin levels in most patients. Medgenics' Biopump is a tissue-based platform technology that processes a toothpick sized sliver of the inner layer of the subject's skin and is intended to provide sustained-action protein therapy for the treatment of a range of chronic diseases, including hepatitis C, hemophilia, and multiple sclerosis.

• Medtronic (Minneapolis) reported the completion of enrollment in PROTECT, the company's global study comparing its Endeavor drug-eluting stent (DES) to Johnson & Johnson's Cypher DES. PROTECT is powered to detect a clinically significant difference in rates of stent thrombosis between the two devices. Stent thrombosis is a rare but serious adverse event in which a blood clot forms inside the stent, with the potential to cause heart attack or death. Occurrences after one year post-implant are called very late stent thrombosis (VLST) and a subject of significant concern. VLST emerged as a safety concern with the first generation of DES in 2006, when clinical trials conducted to support the regulatory approvals of these devices revealed a numerical increase in the rate of VLST compared to BMS controls.

• Medusa Medical Technologies (Halifax. Nova Scotia) said its electronic patient care reporting software, the Siren ePCR Suite, now has an interface with the Philips HeartStart MRx monitor/defibrillator. Siren ePCR Suite is a patient care reporting system. It helps paramedics to administer care while recording critical patient data that they transmit in real-time to receiving facilities. Siren ultimately improves data accuracy by downloading data from the HeartStart MRx directly into the tablet PC software, including ECG, vitals, treatments, and events. This system helps to support a decrease of discovery-to-treatment times by enabling the patient's care to be evaluated and treatment to be given en route to the hospital.

Meridian Bioscience (Cincinnati) has received FDA clearance for a new test for Campylobacter. Launched as Premier Campy, the EIA test provides for optimized detection of Campylobacter infection, the most commonly diagnosed bacteria for food borne illness in the U.S. the company says there is a "significant need" for the Campy test because it provides a solution to several concerns associated with culture testing, currently the most commonly practiced lab technique for detecting the campylobacter bacteria. With culture, there is a potential for reduction in sensitivity due to variable culturing procedures, specimen viability, and inhibitory antibiotics in culture media. Campy reduces these concerns with a consistent EIA method that measures the antigen instead of the fragile bacteria in an environment that is less inhibitory than current culturing procedures.

• MDS Analytical Technologies (Sunnyvale, California) reported the availability of MetaMorph 7.6 software, which features new application modules for 3-D motion tracking and micronuclei detection. Another enhancement to MetaMorph 7.6 is the Micronuclei Application Module, a new product that allows users to find, evaluate and quantitate micronuclei in any nucleated cell. Using additional probes, the new module also enables users to differentiate between mitotic, apoptotic, and necrotic cells.

• Mikai (Genova, Italy), a privately held medical device company, reported the market launch of its Falena Interspinous Decompression Device. Falena, a small titanium and PEEK implant inserted during minimally invasive back surgery, treats lumbar spinal stenosis (LSS) providing patient pain relief.

• Mpathy Medical (Raynham, Massachusetts) reported an extension of its surgical solutions for pelvic floor reconstruction. The newest additions include Restorelle A & Restorelle P for anterior and posterior compartment vaginal repair. Restorelle A & P are minimally invasive surgical solutions for the repair of anterior and posterior compartment defects through a single vaginal incision. Restorelle is constructed with a physiologically compatible mesh material — Smartmesh Technology — which was designed by a surgeon specifically for the female anatomy and delivers near-zero erosion rates, optimal tissue incorporation, and more collagen growth than heavier meshes.

• Non-Invasive Monitoring Systems (Miami) said that the FDA has granted approval to NIMS to market Exer-Rest as a Class I (exempt) therapeutic vibrator with the following intended uses: "as an aid to temporarily increase local circulation, to provide temporary relief of minor aches and pains, and local muscle relaxation." Exer-Rest has the configuration of a single or twin bed and is fitted with a memory foam mattress. This medical device produces Whole Body Periodic Acceleration [vibration] (WBPA) to an individual (who lies horizontally on the mattress) through repetitive head-foot movements at approximately 140 times per minute during a 30 to 45 minute session. The movements are obtained by a patented motorized platform which is adjustable for speed, distance and time through a wireless digital controller.

• OraSure Technologies (Bethlehem, Pennsylvania) said the FDA has approved its request for 12-month shelf life from the date of manufacture for its OraQuick Advance Rapid HIV-1/2 Antibody Test. The FDA approval is based on enhancements made by OraSure to the manufacturing process and product packaging of its OraQuick Advance test, and represents a six-month increase in shelf life vs. current product available on the market. OraQuick Avance is a rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens.

• Pathway Medical Technologies (Kirkland, Washington) has received FDA clearance to market its newest peripheral atherectomy catheter for use in the treatment of peripheral artery disease (PAD) in the lower limbs. Jetstream G2 is the latest technology innovation from Pathway and the company says it is capable of treating the entire spectrum of disease found in the PAD patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results. Jetstream is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. The Jetstream consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard IV stand. The catheter has an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised tissue and thrombus are continually aspirated from the peripheral treatment site through a port system to a collection bag located on the console. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

• Polymedco (Cortlandt Manor, New York) reported the launch of the BTA stat test. The test is a point-of-care technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine. It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen in voided urine. The specificity of the BTA stat test was 93% to 95% in patients with non-genitourinary diseases and cancers and healthy individuals tested as part of a multi-center study.

• Positron (Indianapolis) said that the FDA has received the company's 510(k) submission for the Attrius Positron Emission Tomography (PET) scanner product line. The Attrius is a cardiac-specific PET-only device that competes with other cardiac imaging modalities with its quantification capabilities and disease management. Positron is involved in the field of cardiac nuclear medicine.

• SurgiQuest (Orange, Connecticut) said its AirSeal Dynamic Pressure System was granted FDA 510(k) approval for smoke evacuation. The AirSeal DPS continuously re-circulates and filters CO2 used to insufflate the abdomen during laparoscopic surgical procedures.Surgeons routinely have to interrupt laparoscopic surgical procedures due to impaired visualization caused by electrocautery smoke and plume within the operative environment.

• Tibion (Moffett Field, California), a developer of bionic devices for the mobility impaired, is introducing the PK100 Bionic Leg Orthosis (formerly known as the PowerKnee) at this week's American Physical Therapy Association meeting in Las Vegas. ThePK100 Bionic Leg Orthosis is an intelligent, wearable, power-assist device for the leg which actively supplements muscle strength to enhance rehabilitation therapy and provide mobility assistance for patients with loss of muscle function. Utilizing sensors throughout the device, the PK100 detects the user's actions, such as sitting/standing, walking, and ascending/descending stairs.

• Uroplasty (Minnetonka, Minnesota) reported the completion of patient enrollment in the randomized, controlled multicenter clinical study of its Urgent PC neuromodulation system for the treatment of overactive bladder symptoms of urinary urgency, urge incontinence and frequency of urinary voids. The study is designed to directly compare the effectiveness of percutaneous tibial nerve stimulation using Urgent PC to a non-active sham. The Urgent PC neuromodulation system is a minimally invasive nerve stimulation device designed for office-based treatment of urge incontinence, urinary urgency and urinary frequency, symptoms often associated with overactive bladder. Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that lead to these symptoms.

• Varian Medical Systems (Palo Alto, California) and BrainLAB (Munich, Germany) reported the introduction of the Novalis Tx platform which enables doctors to perform image-guided radiosurgery on tumors of the lung, as well as of the brain, spine, liver, and prostate, without making a single incision. Novalis Tx performs stereotactic body radiotherapy (SBRT), a form of non-invasive radiosurgery that uses precisely-shaped and targeted radiation beams to treat tumors and non-malignant growths from outside the body. The Novalis uses a linear accelerator, which rotates around the patient to target surgical beams at tumors from virtually any angle. A set of sophisticated image guidance and motion management tools provide clinicians with detailed information about the shape, size and position of the targeted lesion, guide patient set-up and positioning, and monitor motion during treatment.

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