BB&T Staff Writer And Staff Reports

Using a combination of acoustics and algorithms, SonarMed (Indianapolis) is looking to change the critical care respiratory monitoring technologies sector up a bit with its newly approved FDA device.

The application, called the SonarMed Airway Monitoring System (AMS) is designed to monitor breathing tubes for patients requiring ventilators.

What makes the device unique and a game changer, according to the company, is its ability to alert clinicians if there is a problem with a breathing tube, before any physical symptoms are visible on the patient.

“We're changing the game in respiratory care from reaction to prevention“ Andy Cothrel, president/CEO of SonarMed said. “You don't have to wait until a patient turns blue to see that there's a problem with their breathing tube, with this device.“

The SonarMed AMS uses acoustic reflection technology to provide precise, real-time monitoring of breathing tubes. The system can be used to assist clinicians in preventing and detecting conditions that can harm the patient, such as movement of the breathing tube, which can result in ventilation failure or lung damage, and obstruction of the breathing tube, which can deprive the patient of needed oxygen.

“The device sends a sound wave through the [breathing] tube and we listen to those echoes,“ he said. “We then interpret those echoes using an algorithm we developed.“

The algorithm breaks down the problem or issue with the breathing tube into three categories and those are movement, obstruction, and placement.

SonarMed AMS is comprised of a monitor and adaptor. The adaptor is placed right outside the patient's mouth and sends signals to the monitor via cable.

One of the key goals in developing the device was to make sure that it was minimally invasive and was not implemented in the body.

Cothrel added that compared with traditional standards of care and available patient information, having this type of adjunctive information about the breathing tube provides clinicians with a more immediate and complete picture of the patient's respiratory support status.

The system was developed with grant support from the National Institutes of Health (Bethesda, Maryland) and the state of Indiana's 21st Century Fund program.

Early institutional investors include SpringMill Venture Partners (Williamston, Massachusetts) and BioCrossroads' (Indianapolis) Indiana Seed Fund, which was formed to be a source of critical pre-venture capital for promising Indiana life sciences companies.

Jeffrey Mansfield, MD, SonarMed co-founder and CTO, said that the early strong financial support was crucial to obtain FDA clearance.

“As with any new medical device development, unexpected challenges arise on the way to FDA clearance,“ Mansfield said. “The support of the NIH and the 21 Fund, along with our investors, was crucial to allow us to address those challenges and continue to move forward. Ultimately, this FDA clearance is a win for patients, caregivers, SonarMed, and all of our investors and financial supporters.“

Elsewhere in the product pipeline:

• Abbott (Abbott Park, Illinois) reported FDA approval of a second test to screen blood, tissue and organ donors for a blood-borne parasite, Trypanosoma cruzi, that causes Chagas disease, a serious and potentially fatal parasitic infection. The test, called Abbott Prism Chagas, detects antibodies to T. cruzi. It is a fully automated and highly sensitive and specific test for the detection of antibodies to T. cruzi. The assay is intended as a screen to detect antibodies to T. cruzi in serum or plasma specimens obtained from donors of whole blood and blood components and other living donors. It is also intended for use to screen organ donors when serum and plasma specimens are obtained while the donor's heart is still beating and in testing blood specimens to screen cadaveric donors (those whose hearts are not beating).

• Ansell (Melbourne, Australia) reported the launch of the Gammex Powder-Free glove with AMT Antimicrobial Technology. The company claims it is the first surgical glove which uses an antimicrobial coating to provide an additional level of protection to surgical staff against viruses and bacteria, in the event of a breach during surgery. Extensive in vitro laboratory testing showed that the antimicrobial coating killed greater than 99% of Hepatitis C1 and 99% of HIV-1 (strain Mn) within 60 seconds of exposure through a simulated glove breach. Gammex Powder-Free glove with AMT Antimicrobial Technology also kills between 99.7% to more than 99.999% of 8 common healthcare infectious bacteria, comprising gram-positive, gram-negative, and drug-resistant bacteria (e.g. MRSA, VRE) within 60 seconds from exposure.

• Ascension Orthopedics (Austin, Texas) reported the launch of the Ascension NuGrip CMC Implant. The NuGrip is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint. The Ascension NuGrip is a joint replacement for the base of the thumb made of PyroCarbon, a material known for its superior wear and biocompatibility characteristics. It is a bone-preserving, reliable alternative to soft tissue reconstruction which is the standard treatment for this indication. The implant is a single component which minimizes bone resections and preserves the trapezium. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically-designed stem and collar enhance stability and maintain the anatomy's joint space. The spherical head has an extended circumference which provides maximum opportunity for range of motion within the trapezium.

• Boston Scientific (Natick, Massachusetts) reported the start of patient enrollment in the EVIDENCE clinical trial, which compares the therapeutic effectiveness and cost effectiveness of spinal cord stimulation (SCS) therapy to spine reoperation in patients with failed back surgery syndrome. Patients in the SCS arm of the trial will receive the Boston Scientific Precision Plus spinal cord stimulator system. The trial will examine treatment response rates (leg pain relief with no request for the alternative therapy) at six and 24 months. Successful patient response is defined as having greater than or equal to 50% relief of pain in the lower extremities compared to pain levels prior to the intervention. The Precision Plus delivers electrical signals that travel along nerve fibers through the spinal cord to the brain. The system masks pain signals by delivering doses of electricity to change pain signals into signals that the brain interprets as a pleasant sensation called paresthesia. Spinal cord stimulation is prescribed for patients with chronic pain in the trunk and/or limbs who have not received adequate relief from physical therapy, pain medications, prior surgeries or other methods.

• Codman & Shurtleff (Philadelphia) reported the launch of the Neuroscout 14 Steerable Guidewire, a newly developed steerable guidewire that facilitates the placement of diagnostic or therapeutic catheters within the neurovasculature. Neurovascular guidewires are placed inside catheters, flexible tubes that are used to carry coils or stents to treat conditions such as aneurysms and cerebral arteriovenous malformations, the two leading causes of hemorrhagic stroke. The Neuroscout 14 Guidewire features a flattened distal segment with a stainless steel core that retains its shape over time, enabling easy vessel access and re-access. A technologically enhanced surface with a highly lubricous surface coating reduces frictional forces with compatible devices and a 10 cm platinum distal coil section provides increased visualization under fluoroscopy.

• Christie Medical Holdings (Memphis, Tennessee) reported the launch of VeinViewer Vision, the third generation of VeinViewer technology. Like its predecessor, Vision uses near-infrared light and other patented technologies to project a digital image of patient vasculature directly onto the surface of the skin in real time. This provides clinicians with a non-invasive adjunct technology for various clinical treatments and procedures including IV insertions, PICC line insertions and routine venipuncture.

• Cook Medical (Bloomington, Indiana) reported that patients treated with the Zilver PTX drug-eluting peripheral stent maintained clinical improvement at two years, according to interim results from the Zilver PTX Global Registry presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI; Washington) 33rd Annual Scientific Sessions. The prospective, single-arm study is ongoing to evaluate the stent for the treatment of peripheral artery disease (PAD). Results of a separate pivotal randomized study in a similar cohort of patients are expected to be available later this year. This analysis includes 12-month follow-up data from 721 patients and 24-month follow-up data from 447 patients who received the Zilver PTX paclitaxel-coated stent in the superficial femoropopliteal artery (SFA), a major artery above the knee. The registry study was designed to evaluate stent integrity, event-free survival and freedom from target lesion revascularization. PAD affects more than eight million people in the U.S. and, if not treated, can limit the ability to walk and exercise, as well as place patients at risk for limb loss. PAD patients also have a greater chance of heart attack, stroke and death.

•EndoChoice (Alpharetta, Georgia) received FDA clearance to market its Bonastent fully covered esophageal stent for the treatment of malignant esophageal obstructions, and its Bonastent uncovered biliary stent for the treatment of malignant biliary obstructions. The Bonastent platform has provided physicians treating malignant strictures in the GI tract increased clinical performance attributed to its “Hook & Cross“ wire geometry. The Bonastent's Hook & Cross wire geometry provides segmental compression, reducing stent migration typically experienced with other metal stent platforms.

• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) said it is the first national laboratory to offer customers a 21-marker genetic analysis in combination with a double-blind process for parentage/relationship testing on every sample. The kits consist of 20 autosomal genetic markers and one gender marker. The kits have overlapping genetic systems that, when coupled with independent DNA extractions, yield a double-blind test for every sample. The main purpose of parentage/relationship testing is to detect if the proposed relationship is incorrect. This newest innovation increases the ability to make this determination. For paternity testing, the number of genetic markers used by laboratories to exclude a man in a typical case has increased over the years, giving a more definitive result of non-paternity.

• Lawson Software (San Antonio) reported the general availability of Cloverleaf Integration Services for healthcare organizations needing to manage the critical exchange of health information data inside and outside of their organization. Cloverleaf version 5.8 is designed to enable Integrated Delivery Networks and other healthcare organizations to exchange data across their organizations and with affiliated locations and medical offices. This helps deliver value associated with the deployment of health information exchanges.

• Illumina (San Diego) received FDA clearance for the BeadXpress system for multiplex genetic analysis. According to the FDA's indications of use, the BeadXpress system – consisting of Illumina's BeadXpress Reader and VeraScan software – is an in vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology.

• Maquet Cardiovascular (Wayne, New Jersey) reported the launch of the new Vasoshield pressure controlling syringe for use during coronary artery bypass graft (CABG) surgery. The Vasoshield syringe limits internal “flushing“ pressure and controls vessel distension when harvested grafts are irrigated in preparation for use in bypass surgery. It has been clinically shown that vessels flushed at controlled, lower pressures more effectively overcome spasm, maintain their endothelial and medial layers, and are more likely to provide a high-quality conduit for bypass surgery.

• meridianEMR (Livingston, New Jersey) reported the release of its new native iPhone application – mMobile. Built upon the Apple iPhone Operating System, the application allows providers to access, update, and synchronize patient medical data with their office servers or meridianEMR's exclusive mEHRxChange network. mMobile offers providers a suite of options such as full hospital census, hospital rounding, capture of all CPT, ICD, and other billing information required for hospital billing, adding of new patients or consults as needed, viewing of patient medical data, as well as full synchronization and refreshing of data whenever the network is available. mMobile has been designed to be 100% operational regardless of Internet connectivity, unlike web-based applications that require a full-time Internet connection for use.

• Micronics (Redmond, Washington) received FDA clearance to market its ABORhCard, a qualitative in vitro test that provides a simultaneous determination of an individual's ABO blood group and Rh factor status. It is not for use for blood bank processing of blood products, for determining RHD status for the purpose of administration of Rh immunoglobulin, or for screening purposes prior to transfusion. The device is intended for single use for individual blood group determination for educational and informational purposes. Micronics describes the ABORhCard as a single-use, disposable device that uses the necessary blood typing reagents. While other manual methods for blood typing are available, such products and methods generally either require liquid reagents that need refrigeration or their use is open to the environment. In comparison, the ABORhCard is a closed system that is stored at room temperature and provides a user friendly, integrated test that produces a visible result in minutes following collection of a small sample of blood.

• OmniGuide (Cambridge, UK) reported clinical study results which demonstrate the safety and efficacy of its handheld fiber for CO2 laser stapedotomy compared to the handheld KTP laser, and the availability of two next generation products for otology. The surgical procedure to repair hearing loss due to otosclerosis is stapes surgery and lasers are used to precisely cut and manipulate the miniscule bones of the ear to restore hearing.

• Physio-Control (Redmond, Washington), a subsidiary of Medtronic (Minneapolis), reported the launch of Version 4.1 of its Lifenet System. Lifenet System 4.1 is a web-based platform designed to share emergent patient information between Emergency Medical Services (EMS) and hospital care teams. The latest release includes Lifenet Adapter, an interface between the Lifenet System and various manufacturers' 12-lead management systems. Hospitals now have the ability to standardize the management of chest pain cases regardless of the monitoring equipment used by EMS in the field.

• PolyTouch Medical (Misgav, Israel) said it has filed a premarket 510(k) application with the FDA for PatchAssist, a laparoscopic mesh deployment and placement device that enables accurate mesh placement in laparoscopic ventral hernia repair potentially reducing procedure time by 30%-50%. PatchAssist is a standalone surgical mesh placement device that is compatible with all common hernia meshes and supports a wide span of mesh sizes including the largest mesh sizes in the market. PatchAssist helps surgeons to choose their preferred mesh during LVHR procedures.

• US HIFU (Charlotte, North Carolina) received approval from its data and safety monitoring board (DSMB) to continue enrollment in its FDA-approved prospective clinical trial investigating the use of high intensity focused ultrasound (HIFU) technology delivered via the Sonablate 500 medical device to treat localized primary prostate cancer. Sonablate HIFU destroys diseased prostatic tissue with extreme heat generated from focused ultrasound waves. The ultrasound energy is delivered in rapid-fire succession to targeted tissue throughout the gland. The tissue at each target is destroyed while surrounding tissue remains unharmed. The Sonablate 500 is a minimally invasive medical device that uses ultrasound energy to destroy tissue within the body.

•ViaSmart (Harrison Township, Michigan) has introduced its latest products, the PowerCaddy and the TechTote. Designed specifically to assist healthcare professionals in positively identifying both the patient and the specimen collected, the PowerCaddy carries and protects a PDA (hand-held computer) and a mobile printer in a lightweight, durable tote. Each caddy includes a tube rack and plenty of space for tools and supplies. ViaSmart says unique to the PowerCaddy is the way in which the components in the caddy are charged. This device uses technology to simultaneously charge the internal batteries of both a PDA and mobile printer by placing the PowerCaddy upon a charging bank. The TechTote is similar to the PowerCaddy, but was developed for customers who already have charging devices but still want the protection and convenience of transporting essential data track and labeling equipment.