BB&T and BB&T Staff Reports

Ophthalmologists will soon have a way of treating the cause of meibomian gland dysfunction (MGD) – also known as evaporative dry eye – rather than just treating the symptoms of the condition with eye drops. The FDA has cleared the LipiFlow Thermal Pulsation System from TearScience (Morrisville, North Carolina) for MGD.

The company said LipiFlow will be available on a limited basis in the U.S. through the end of the year, with a full product launch to follow. LipiFlow is designed to remove meibomian gland obstructions by applying directed energy to a patient's eyelid during a 12-minute in-office treatment.

“We are gratified and blessed to have secured FDA clearance for the LipiFlow,“ said Tim Willis, CEO and co-founder of TearScience. “This marks an important day for ophthalmologists as now our advanced technology is available for their dry eye patients.“

Willis told Biomedical Business & Technology that the two most common forms of dry eye are evaporative and aqueous deficient, with the majority of dry eye patients – 65% to 70% – falling into the former category. Evaporative dry eye occurs when the aqueous in tears evaporates at a faster rate than normal due to an insufficient lipid (oil) layer on the surface of the tear film. It's a result of blockage in the oil-producing meibomian glands located within the eyelids, or MGD.

“At last, physicians will have the necessary tools they need to break the cycle of frustration for many dry eye patients,“ said Alan Carlson, MD, chief of the Corneal, External Disease, and Refractive Surgery Service at the Duke Eye Center (Durham, North Carolina). “Now, with FDA clearance to market the LipiFlow, TearScience provides a new, innovative alternative treatment that delivers effective relief for many patients who desperately need it.“

Common symptoms of the disease include eye irritation, dryness, redness, tiredness, and visual disturbances. TearScience's integrated, in-office system addresses a root cause of evaporative dry eye, the obstructed glands, the company noted. By assessing the tear film and meibomian gland function, physicians can determine whether MGD is the primary cause of a patient's evaporative dry eye and whether a patient is a good candidate for the LipiFlow treatment.

TearScience gained FDA clearance by demonstrating the safety and effectiveness of LipiFlow through a U.S.-based nine-center randomized controlled clinical trial for the treatment of evaporative dry eye.

“The patients generally have said it actually feels kind of nice,“ Brian Regan, head of marketing at TearScience, told BB&T when asked about patient comfort level during the treatment. “It was described by a lady in Canada as feeling like a hot rock spa treatment. In our FDA clinical study we had people rate their pain on a scale of 1 to 10, and the average rating was 1.4 with 1 being just a sensation or awareness of pressure without pain.“

Willis said it takes patients anywhere from a couple of days to several weeks to feel the full benefits of the treatment, depending on how severe their case was before they received the treatment. He noted that some of these patients have been suffering from the condition for several years.

“What most physicians have done up to this day is provide the patient with drops,“ Willis said. “In the future they'll still be using drops with our system but we've given physicians the best tool we can so that the maximum number of these glands can be opened and . . . the patient can experience symptom relief and it treats the root cause of why this occurs.“

“The LipiFlow system is a very unique, very exciting system,“ said Stephen Lane, MD of Associated Eye Care (Stillwater, Minnesota.) “For the first time, we have a dry eye treatment regimen that patients can undergo in 12 minutes per eye in a physician's office. When LipiFlow patients were seen for follow up appointments, they were very excited about the significant decrease in symptoms with many noting a significant improvement in the comfort level they were having – even from the first day of the procedure.“

Elsewhere in the product pipeline:

• Aesculap Implant Systems (Center Valley, Pennsylvania) has introduced the Hydrolift Vertebral Body Replacement (VBR) system. This system provides surgeons with a stable, bone preserving construct for treatment of burst fractures and tumor removal of the thoracolumbar spine. The Hydrolift VBR has a hydrostatic distraction and an endplate design. Hydrolift is the only VBR to use hydrostatic force for distraction to minimize vertebral body endplate damage and optimize tactile feedback, the company said. Applied pressure to the endplates is available via a digital read out in Bar and PSI. The Hydrolift VBR is indicated for use in the thoracolumbar spine, T1 to L5, for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma.

• Ascension Orthopedics (Austin, Texas) reported the market release of the Titan Inset Mini Glenoid. The Mini Glenoid is an addition to the Titan Modular Shoulder System, which provides a way to address glenoid arthritis. The Titan shoulder line now offers an inset Mini Glenoid option that is available in round and oval designs. The modularity of the Titan line allows for one system to be used in a number of different applications including: humeral resurfacing arthroplasty, hemi or total shoulder arthroplasty, and press-fit or cemented fracture arthroplasty. Less instrumentation is needed in the operating room and the ease of reproducibility helps provide for consistent patient outcomes, Ascension said.

• GE Healthcare (Chalfont, UK) said the National Aeronautics and Space Administration (NASA) has selected GE Healthcare's Vivid q Cardiovascular Ultrasound system for delivery to the International Space Station (ISS) on its final space shuttle flight. The Vivid q will be launched on the space shuttle Atlantis. The customized Vivid q will be used on-board ISS as part of NASA's human research program, specifically to help assess the impact of long duration microgravity space flight on astronauts. Vivid q is a compact, lightweight diagnostic ultrasound system about the size of a laptop, enabling portability and ease of use. The Vivid q is designed for cardiovascular imaging and enables assessment of LV function and cardiac performance. The panoramic scan feature offered by the Vivid q is a capability NASA has not had available in space before.

• iCAD (Nashua, New Hampshire) reported the availability of iCAD's VeraLook CTC CAD solution integrated into Vital Images' (New York) products as a result of a strategic partnership agreement signed earlier this year. Vital Images is a provider of advanced visualization and analysis solutions for healthcare providers. With this agreement, iCAD's VeraLook CTC CAD solution is now available as part of Vital Images' products worldwide. This collaboration will provide clinicians with computer-aided detection tools for the review and analysis of CT Colonography (CTC) images and will enhance the speed and accuracy of cancer detection. iCAD's advanced image analysis technologies enable healthcare professionals to better serve patients by identifying pathologies and pinpointing the most prevalent cancers earlier. Vital Images' scalable solutions consist of advanced visualization tools, clinical applications, and data management systems. VeraLook is designed to detect and highlight potential polyps during CTC examinations.

• Invibio Biomaterial Solutions reported that, commencing this summer, Kelyniam Global (Canton, Connecticut) will make available Custom Skull Implants (CSI), made using Invibio's PEEK-Optima polymer. Kelyniam, an emerging medical device manufacturer, recently received its FDA 510(k) clearance to market cranial implants. Made on a patient-by-patient basis, Kelyniam CSI says it relies on the exceptional strength, bone-like modulus, radiolucency, purity, versatility and guaranteed supply of high quality PEEK-Optima polymer. The Kelyniam CSI is intended to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects while promoting a better anatomic fit versus conventional reconstruction methods and materials.

• Karl Storz (Tuttlingen, Germany) reported the launch of a new concept in high-resolution visualization for a wide array of open microsurgical procedures, including cardiovascular, spine, small joint applications, pediatric, head and neck, and plastic surgery. Designed to function as more than a simple surgical tool, the Vitom System provides enhanced visualization and a better ergonomic working position for surgeons, as well as a useful method for presenting and sharing clinical images during training and education, and a simplified means of documenting procedures. The Vitom System combines an exoscope with a high-definition video camera system developed originally for endoscopic procedures. The system includes a display unit, light source, holding systems and documentation unit.

• Medtronic's Spinal Business (Memphis, Tennessee) reported the release of the Kyphon Xpander II Inflatable Bone Tamp (IBT) and the Kyphon Inflation Syringe – the Kyphon Xpander II IBT System – for the treatment of vertebral compression fractures with minimally invasive Kyphon Balloon Kyphoplasty. The new balloon material used in Kyphon Xpander II IBT System offers control during inflation and greater lifting force than the Kyphon Xpander IBT. It is combined with the Kyphon Inflation Syringe, which provides ease of use to customers for use during a balloon kyphoplasty procedure, Medtronic claims. During the minimally invasive balloon kyphoplasty procedure, a needle and tube are used to create a small pathway into the fractured bone, generally on both sides of the vertebral body. Orthopedic balloons are inserted and then inflated inside the fractured bone in an attempt to return it to its correct position. Inflation of the balloons creates cavities in the vertebral body that are filled with bone cement, forming an “internal cast“ to support the surrounding bone and stabilize the fracture.

• NeuroMetrix (Waltham, Massachusetts) said it met its planned marketing launch date for NC-stat|DPNCheck, which is an accurate and quantitative test for the evaluation of systemic neuropathies such as diabetic peripheral neuropathy (DPN). NC-stat DPNCheck measures sural nerve conduction velocity and response amplitude, which are standard biomarkers for diabetic peripheral neuropathy. The device is a modified version of the NC-stat device which has been shown to accurately detect DPN.

• Neurowave Medical Technologies (NMT; Chicago) has introduced Nometex, a new transdermal neuromodulation device to treat patients with chemotherapy-induced nausea and vomiting (CINV). Nometex was designed to improve the quality of life for the more than 1.2 million Americans who undergo chemotherapy-radiation treatments each year. Its approach to delivering continuous protection against CINV garnered enthusiastic professional response at ASCO. Nometex is a non-drug treatment that relies on NMT's neuromodulation technology platform to positively modulate neural pathways using electrical pulses for prophylaxis, breakthrough, or refractory CINV. Offering patients a rapid onset of action, usually within minutes, it has been clinically proven to reduce CINV without the side effects associated with pharmaceuticals.

• NuGEN Technologies (San Carlos, California) reported the introduction of the Encore 384 Multiplex System. The technology uses a refined set of barcodes that may be used in a number of combinations to provide flexible multiplexing capability of up to 384 uniquely coded libraries. This solution for deep multiplexing allows scientists to undertake large scale projects while greatly reducing costs. Accelerated sequencing throughput has created challenges in upstream sample preparation, particularly for projects involving large numbers of samples requiring relatively shallow sequencing coverage as costs associated with these projects can be prohibitive. The ability to multiplex a large number of sequencing libraries in the same sequencing run leverages platform capacities and enables higher throughput at a lower cost per sample.

• OMNIlife science (East Taunton, Massachusetts) reported FDA clearance of its Apex PS Knee. The Apex Posterior Stabilized (PS) Knee is the latest addition to the Apex Knee product family. The Apex PS Knee maintains the key design elements of the existing Apex Cruciate Retaining (CR) Knee but offers the post and cam system preferred by surgeons who use a posterior stabilized knee replacement. The design allows the Apex PS Knee to have up to an additional 30 degrees of uninterrupted patella track compared to competitive posterior stabilized knee designs that require a larger bone resection. The extra patella track potentially reduces the chance of experiencing a problem that has been associated with knee replacements known as patella “clunk.“

• OSI Systems (Hawthorne, California) said that its Healthcare division, Spacelabs Healthcare, launched Pathfinder SL, a Holter analysis solution that delivers technology, rapid analysis and enhanced accuracy in the exploration of a patient's cardiac condition. The company also introduced Sentinel 8, the latest version of Spacelabs Healthcare's Cardiology Information Management System.

• Roche Applied Science (Penzberg, Germany) launched its new real-time PCR system. The LightCycler Nano Instrument supports technology for fast PCR protocols featuring leading edge thermal resolution and reproducibility. Roche says this newcomer to the LightCycler family offers plenty of options in an incredibly small platform. The LightCycler Nano System can be used in networks, and does not require a dedicated computer. Either a preferred Mac, PC, or Linux Operating System, or simply a USB stick can be used to start a run.

• RTI Biologics (Alachua, Florida) reported the launch of BioAdapt DBM Foam, a flexible demineralized bone matrix solution with unique handling capabilities. BioAdapt is the newest addition to RTI's osteobiologic product portfolio. BioAdapt is a sterile, room temperature implant offered in five pre-shaped options to meet the bone grafting needs of trauma, reconstructive, spine and extremity surgeons. With foam-like properties, BioAdapt expands with hydration to adapt to the contours of the surgical site.

• Sanuwave Health (Alpharetta, Georgia), a company focused on the development of noninvasive, biological response activating devices in regenerative medicine, has submitted to the FDA the third and final module of its PMA application for the dermaPACE device for the treatment of diabetic foot ulcers. PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing cascade. This results in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures. PACE treatment triggers the initiation of an accelerated inflammatory response that speeds wounds into proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help reinitiate the body's own healing response. The goal of the dermaPACE pivotal trial was to establish superiority in diabetic foot ulcer healing rates using the dermaPACE treatment compared with sham control, when both were combined with the current standard of care. The standard of care included wet-to-dry dressings and, for some patients, offloading with a walking boot. Secondary trial endpoints included time to closure, reduction in total wound surface area and volume, rate of improvement, long term safety, and skin appearance and pain assessments.

• SpinalCyte (Houston) reported the publication of its research completed with Rice University, titled, “Chondrogenic Differentiation of Neonatal Human Dermal Fibroblasts Encapsulated in Alginate Beads with Hydrostatic Compression Under Hypoxic Conditions in the Presence of Bone Morphogenetic Protein-2.“ Published in the June 2011 issue of Journal of Biomedical Materials Research, the company says the research provides validation of SpinalCyte's core technology to regrow the spinal disc, using human dermal fibroblasts. The researchers note that as a result of intermittent hydrostatic pressure, the dermal cells were successfully differentiated into cartilage type cells necessary to regrow the nucleus pulposus. The nucleus pulposus is a gelatinous material that acts as a cushion or shock absorber to the spinal column. It functions to distribute hydraulic pressure in all directions within each disc under compressive loads. The nucleus pulposus consists of chondrocytes, collagenfibrils, and proteoglycan aggrecans. SpinalCyte makes an autologous solution for nucleus replacement technology using human dermal fibroblasts.

• Suneva Medical (San Diego) reported the expansion of its core aesthetics injectable business with approval from Health Canada to market Bellafill, its long lasting dermal filler for nasolabial folds or smile line correction. Bellafill is composed of bovine collagen and engineered microspheres and includes lidocaine for improved patient comfort. This distinct formulation offers patients long-lasting wrinkle correction.

• Vasomedical (Westbury, New York) reported FDA clearance to market its Vasomedical-BIOX Model 2302 Combined 12-Channel ECG Holter/Ambulatory Blood Pressure Monitor and Model 1804 Ambulatory Blood Pressure Monitor. These new models complement the company's already cleared Model 1305 3-Channel ECG Holter Monitor and Model 2301 Combined 3-Channel ECG Holter/Ambulatory Blood Pressure Monitor. Vasomedical now offers both 3-channel (Model 2301) and 12-channel (Model 2302) Combined Holter ECG/ABP Monitors. While they can also be configured by the user to record ECG or blood pressure data only, the newly cleared Model 1804 and the previously cleared Model 1305 provide economic alternatives for applications where only blood pressure or ECG recording is needed.

• Vertos Medical (Aliso Viejo, California) said that one-year post-study follow-up data on its mild procedure for lumbar spinal stenosis (LSS) have been published in the peer-reviewed journal Pain Practice. In “Long Term Results of Percutaneous Lumbar Decompression mild for Spinal Stenosis,“ authors concluded that the mild procedure is safe and provides long-term pain relief and improved mobility in patients with LSS. The authors found that mild patients continued to experience a statistically significant and clinically relevant reduction in pain and improvement in mobility at one year, according to a number of patient-reported outcomes measures. mild is an image-guided percutaneous (through the skin) decompression laminotomy procedure used to treat patients with LSS, a condition diagnosed in 1.2 million patients annually in the U.S. A less invasive alternative to open or endoscopic surgery, mild safely and therapeutically reduces pain and increases mobility while maintaining structural stability.