BB&T Staff Writer, and Staff Reports

For up to 10% of people with sleep disordered breathing, standard CPAP machines won't do the trick. Royal Philips Electronics (Murrysville, Pennsylvania) has launched a new, enhanced version BiPAP autoSV Advanced for patients who have both obstructive sleep apnea and central sleep apnea as well as Cheyne-Stokes Respiration, a periodic breathing disorder.

Philips has targeted a market where there is just one other player in the U.S., ResMed (San Diego).

“Standard CPAP delivers the same pressure level when you breathe in and out; the BiPAP is several steps beyond that,“ Brian Bunofsky, global product manager for bi-level sleep therapy devices for Philips Respironics, said. “An auto titrating algorithm constantly changes pressure levels and adapts to patients' needs. For example, patients get worse when they turn on their backs and it adjusts. When they don't need the higher pressure, the device will lower the pressure level automatically. In parallel, it's trying to stabilize the patient's breathing pattern. On each and every breath it sets a peak flow and changes the pressure. If a patient has an apnea (a cessation of breathing) for at least 10 seconds, the device will deliver a breath for the patient.“

Regular obstructive sleep apnea is characterized by snoring and interrupted breathing, with patients waking hundreds of times during the night. They suffer sleep loss, headaches and other potential health complications.

The auto adjusting EPAP uses the REMstar Auto titration algorithm which enables the machine to automatically distinguish between obstructed and clear airway apneas and adapting pressure to patients' needs as their conditions change due to weight, alcohol use, or lifestyle. The automatic adjustment of EPAP simplifies titration and achieves efficacy at the minimum pressure levels. BiPAP autoSV Advanced also has Bi-Flex technology for patient comfort, providing pressure relief during exhalation and at critical transition points.

When a person has central apneas it's imperative not to over- or under-ventilate, according to Philips. The delivery of automatically calculated back-up breaths encourages spontaneous breathing at the patient's own natural rate.

BiPAP autoSV also integrates heated humidification and built-in digital data storage. The company's Encore patient management system automatically collects patient information and enables the entire care team to continuously monitor and track treatment progress and transfer new or updated prescriptions.

Bunofsky said that sleep studies for these patients are conducted in the same manner as for regular sleep apnea patients, although the diagnosis may take longer.

Although the BiPAP autoSV Advanced was FDA cleared last November, product launch has just begun in earnest. The Philips team is also working to update OmniLab titration devices at sleep labs across the country so that the complex disorder can be titrated effectively and the new product can be prescribed.

“We're in the early stages of getting them into the labs,“ said Kevin Dorcak, Philips' U.S. marketing manager. “Right now less than 25% of sleep labs have the needed technology upgrade.“

Both Bunofsky and Dorcak claim that Philips has converted 80% of its prior titration devices over to OmniLab titration devices.

Bunofsky said Philips' product outshines its closest competitor, ResMed, because of “... our ability to automatically adjust pressure levels to treat the obstructive component. The ResMed unit has fixed levels. Ours adapts more to the patient and hopefully leads to more compliance.“

ResMed's VPAP Adapt SV was the first FDA-cleared device in 2005, designed to treat complicated sleep apnea. VPAP Adapt SV uses adaptive servo-ventilation to adapt to a patient's ventilatory needs on a breath-by-breath basis.

Interestingly, the two competitors joined forces a few months ago to support the sleep community's efforts to educate primary care physicians about untreated sleep apnea through independent continuing medical education programs for primary care physicians funded with educational grants by the two companies.

Starting last fall, live programs were provided through two independent primary care education providers in 17 U.S. cities. The goal of the program is to educate 7,200 clinicians by June 2010.

The American Sleep Apnea Association (Washington) reports that untreated, sleep apnea can cause high blood pressure and other cardiovascular disease, memory problems, weight gain, impotency and headaches. Untreated sleep apnea may also be responsible for job impairment and motor vehicle crashes due to the sleep deprivation.

Elsewhere in the product pipeline:

• Bausch & Lomb (Aliso Viejo, California) said that it is launching the Crystalens AO, the first aberration-free accommodating intraocular lens (IOL) with aspheric optics to cataract surgeons worldwide. The Crystalens AO has prolate aspheric surfaces and is designed to be free of spherical aberration. It is designed to improve retinal image quality without compromising depth of field and therefore provides greater quality of distance and intermediate vision. The Crystalens AO is comprised of biosil silicone and has a thin and uninterrupted barrier edge. It will be inserted using the CI-28 injector in a controlled manner through an un-enlarged phaco incision which is a routine requirement in today's cataract surgical procedure. Unlike a standard cataract replacement lens, Crystalens is designed to not only eliminate a patient's cataract, but to provide a full range of vision so that the patient can see near, far and everywhere in between. Many Crystalens patients hardly, if ever, need their glasses after surgery, the company said.

• Biocomposites (Staffordshire, UK), reported the launch of geneX ds, a dual syringe mixing and minimally invasive delivery system containing geneX, the resorbable bone graft material with a negative surface charge. geneX is a synthetic bone graft material with a unique bi-phasic composition manufactured through a process ZPC (Zeta Potential Control) that confers the product with a reproducible negative surface charge. This property stimulates bone cell activity, accelerating bone formation and fusion by harnessing key proteins and directing osteoblast adhesion and proliferation for rapid osteogenesis. geneX is fully resorbable and is completely replaced by bone. geneX overcomes the surgeon's reliance on donor tissue presenting both a cost saving and a reduction in the risks associated with its use. The powder and liquid components of geneX are provided pre-packed in separate syringes. The syringes connect together and allow a faster, simpler and cleaner way for mixing geneX. The resulting setting paste can then be delivered through an 8cm dispenser.

• Cepheid (Sunnyvale, California) said it has been granted Emergency Use Authorization (EUA) from the FDA for its Xpert Flu A Panel test. The test, which runs on Cepheid's GeneXpert System, identifies the 2009 H1N1 influenza virus in less than one hour. The FDA has authorized Cepheid's Xpert Flu A Panel to be used in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform “moderate complexity“ (not waived) testing, enabling the test to be performed in hospital near-patient settings. The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System combines on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.

• Continua Health Alliance (Beaverton, Oregon) reported the first end-to-end connected health solution based on the Continua architecture. Continua has heralded the development as a significant milestone in the group's mission to establish an ecosystem of interoperable personal connected health solutions. “One of Continua's key goals has been to enable end-to-end interoperability for connected heath solutions. By providing a framework of standards-based interfaces, Continua is spurring innovation while removing barriers to global implementation and adoption,“ said Rick Cnossen, President of Continua Health Alliance. Continua Health Alliance is a non-profit, open industry coalition of the finest healthcare and technology companies joining together in collaboration to improve the quality of personal healthcare.

• Cytori Therapeutics (San Diego) has been granted FDA clearance for its PureGraft System. PureGraft allows a patient's own fat tissue to rapidly be prepared in approximately 15 minutes for re-injection back into the same patient for aesthetic contouring. PureGraft is able to prepare both small and large volumes of fat grafting tissue ranging from 50 mL to 250 mL. Puregraft maintains sterility while optimizing the yield of tissue to be grafted, which provides significant use to physicians. In contrast to traditional methods of graft preparation, PureGraft washes the graft and drains the tumescent fluid, free lipid and debris in a closed sterile system, allowing for a cleaner graft in less time than it would take to prepare a comparable volume of graft tissue traditionally, the company says.

• Humedica (Boston) reported the release of the MinedStream, a real-time and predictive clinical surveillance solution. This software has been designed to help healthcare organizations improve the quality and safety of patient care. Humedica MinedStream should improve healthcare organizations' financial performance by reducing the number of preventable complications and ensuring compliance with performance measures, such as the core measures of the Joint Commission. Humedica said MinedStream complements its current suite of products, which includes Humedica MinedShare, an operational and financial benchmarking tool. The company added that MinedStream is a real-time predictive clinical surveillance tool that identifies high-risk, high-cost patients, tracks necessary care and supports clinicians as they intervene to improve care. This allows hospitals and medical groups to enhance operational performance, reduce organizational cost and optimize payer reimbursement.

• Medizone International (San Francisco) reported that its third round of testing and data logging for the enhanced AsepticSure technology is now complete. Test results achieved over the past two months now predictably demonstrate greater than six logs of bacterial “kill“ across the full spectrum of hospital contaminants including MRSA, C difficile, E coli, Pseudomonas aeruginosa and VRE in addition to the internationally accepted surrogate for Anthrax, Bacillus subtilis. Significantly, these results have been replicated on more than a single surface material. “This latest round of laboratory testing has confirmed beyond any reasonable doubt that our enhanced AsepticSure technology can reliably achieve sterilization standards for virtually any bacterial contaminant found in a hospital setting,“ said Michael Shannon, Medizone's director of medical affairs.

• Pall (Port Washington, New York) reported the launch of 5 mL PRC prepacked chromatography columns to deliver faster and more consistent protein purification processing. Pall's PRC prepacked columns for ion exchange and mixed-mode chromatography lower processing costs and save laboratory time by reducing inconsistencies associated with manually packed columns. The columns provide a direct connect to existing lab-scale chromatography systems. The columns are efficient (greater than or equal to 2,500 plates per meter) and their performance remains consistent throughout a process. PRC columns are available in a wide range of separation media to support applications including native and recombinant proteins, plasmids, vaccines, monoclonal and polyclonal antibodies, and plasma derivatives.

• A new blood test that identifies changes in DNA associated with colorectal cancer is now available in the U.S. through Quest Diagnostics (Madison, New Jersey). The test is designed to aid the detection of colorectal cancer, the third leading cause of cancer-related deaths. The new test is based on DNA methylation of the Septin9 gene, a biomarker associated with colorectal cancer that was identified by Epigenomics, a cancer molecular diagnostics company. Quest Diagnostics claims it is the first commercial laboratory in the U.S. to offer a laboratory-developed test based on the Septin9 biomarker. The InSure fecal immunochemical test is an FDA-cleared fecal occult blood test for use in screening for sources of lower gastrointestinal bleeding, based on laboratory testing of a stool-based specimen. The company also offers mutation testing to help predict if a patient with metastatic colorectal cancer will respond to certain therapies and genetic testing to aid in evaluating a patient's inherited predisposition to colorectal cancer. In addition, the company provides anatomic pathology testing services for colorectal cancer, such as biopsy testing of tissues identified through colonoscopy.

• SeraCare Life Sciences (Milford, Massachusetts) reported that it has added five new, products to its portfolio, including:

— A set of specific controls for infectious disease testing that offer comprehensive assay coverage for the Abbott Architect testing platform.

— Accurun 1 Series 2700 Multi-Marker Positive Control, which allows end-users to develop a more efficient quality control program by offering a single product for multiple antigens related to various types of HIV, hepatitis, cytomegalovirus and T-lymphotropic virus.

— Accurun 106 Series 1000 Positive Control, which provides positive diagnostic control detection of the HIV type 1 antigen and is critical for monitoring the performance of HIV tests that allow for the early detection of HIV infection.

• Synovis Life Technologies (St. Paul, Minnesota) said that its subsidiary, Synovis Micro Companies Alliance, has received exclusive worldwide distribution rights to sell the GEM SuperFine MicroClip. The company reported this new product is the smallest clip on the market today and is designed to stop bleeding during surgical procedures. Microsurgeons will use the GEM SuperFine MicroClip in various specialties – plastic and reconstructive, head and neck, orthopedic and hand – in procedures ranging from breast reconstruction to tissue grafts following cancer surgery and the reattachment or repair of fingers and limbs. The GEM SuperFine MicroClip is made of pure, annealed titanium for a malleable consistency that allows for zero memory which prevents the tip from opening after application. The clip is biologically inert, and the non-ferrous titanium is safe for use with MRI or related scanning equipment. The chevron shape of the GEM SuperFine MicroClip provides progressive and encompassing tip-to-tip closure for secure vessel occlusions. The diamond shape grooving and interlocking atraumatic teeth on the clip's inner surface ensure a firm multi-direction non-crushing grip. Additionally, the ergonomically designed cartridge includes an adhesive backing for precise and effortless clip loading.

• Taoglas (Chula Vista, California) said it has launched a flexible circuit loop antenna, which can deliver more than 40% efficiency in healthcare monitoring devices. The FLA.01 antenna is a penta-band cellular antenna that is embedded inside medical devices and can achieve high performance, particularly with customization. The technology can be applied to any frequency including license free bands such as 433MHz, 868MHz, 915MHz, 2.4GHz and higher. With the FLA antenna, medical device designers can ensure their devices now achieve reliable, consistent wireless connections for transmitting patient data and also meet healthcare industry tests, the company says.

• Vignet (Washington) has introduced its Connected Health Services platform infrastructure for mobile health devices and services. The new “person-centered“ platform allows users to capture, aggregate, analyze and share data with their mobile devices, leveraging any wired or wireless interface, such as Bluetooth, ZigBee, Bluetooth LE and USB. Vignet's platform works with most mobile phones, PCs and gateways to provide connectivity for both patients and medical professionals without the need for dedicated hardware. The platform also incorporates PAN and WAN standards as specified in the interoperability guidelines developed by the Continua Health Alliance. Vignet has also defined an API for the Connected Health Services platform that third party developers can use to build applications for converged health and mobility.

• Welch Allyn (Skaneateles Falls, New York) said that its Green Series Medical Exam Lights are now available. It is one of the first medical exam lights offered domestically that feature energy-efficient light-emitting diodes (LEDs), as opposed to halogen lamps, according to Welch Allyn. The new lights do not require bulb replacement and produce bright, white light with a color temperature of 5,500 K, providing light that offers 50,000 hours of life. The white LEDs used in the Welch Allyn Green Series Medical Exam Lights provide true tissue color rendition and a uniform spot—no dark or hot spots—and minimal heat dissipation for greater patient comfort and safety. The touchless on/off and intensity control features reduce the risk of infections due to cross-contamination, and the ergonomic design simplifies cleaning.