BB&T Senior Staff Writer and Staff Reports

Nurses and doctors simply cannot be in 36 places at once. But a monitoring system recently cleared by FDA might be the next best thing.

The agency has cleared the EverOn Central Display Station (CDS) from EarlySense (Ramat Gan, Israel). The clearance covers the ability of the system to collect real time vital sign information from up to 36 EverOn bedside monitors and display the information on a computer screen at the nurse's station, the company said. This data is also replicated on large LCD displays on the medical surgical floors enabling the clinical teams, as they move from room to room, to continuously observe the condition status of their patients and any corresponding patient safety alerts.

Perhaps the best part about the system is that the data is collected by a contact-free sensor placed under the hospital bed mattress, EarlySense noted, adding that the system has no leads or cuffs and never touches the patient.

“When you look at hospitals today, they are facing a growing challenge of an admitted population that is more and more acutely ill,“ Avner Halperin, CEO of EarlySense, told Biomedical Business & Technology. “On general care floors the patients there on average are clearly getting sicker and sicker due to an aging population, co-morbidities, etc. and the fact that anyone who is doing even half-well is sent home.“

Halperin also noted the increasing pressure hospitals are under from payers and regulatory bodies to be more efficient and also the fact that any errors that are made fall on the hospital's bottom line.

“With today's increased focus on improved quality and patient safety targets coupled with the challenges of shrinking budgets, hospitals are turning to advanced technologies such as EverOn to provide effective alerts on high risk situations,“ Halperin said.

He added that being able to identify early warning signs of patients who are going down hill helps hospital staff see where the risks are and be able to proactively do something about it. The EverOn CDS has been designed to do just that, he said.

According to EarlySense, the CDS is a vital part of its EverOn patient monitoring system. It continuously presents and transmits the respiratory and heart rate data of patients. In addition, it displays bed exit alerts for preselected patients. This information helps to minimize falls, the company noted. Furthermore, the CDS alerts nurses when the system has determined that patients, who are under a pressure ulcer prevention program, need to be turned. This helps nurses to more proactively attend to these patients.

EarlySense also noted that the EverOn system is becoming an integral part of the nurses' workflow as, via the CDS, it sends relevant alerts to their mobile phones, enabling real time notification of any adverse changes in a patient's vital signs.

By making it contact-free, the EverOn system is convenient for both the patient and the nurse and doctor, Halperin said.

Existing monitoring technologies have a high number of false alarms, according to Halperin. He told BB&T that this “cry wolf syndrome“ or, to use the technical term for it, “alarm fatigue“ can render a monitoring system useless. So EarlySense worked long and hard to make the EverOn system quiet, he said. “It is dramatically better than any other system out there in terms of false alarms,“ he added.

But what's really interesting about this particular system, according to the Halperin, is how it all works together. “You've got 36 patients on a floor and they all have their own issues and they've got the sensor underneath the mattress“ monitoring the patients' heart rates, respiratory rates, movements (if they are moving too much or too little) and “with all of this going on, with this system no matter where the medical professional is on the floor, if something is going on they're going to know about it.“

The CDS augments the EverOn contact-free patient supervision system approved in June, the company noted.

Elsewhere in the product pipeline:

• AcuFocus (Irvine, California) reported the launch of the Kamra inlay and the AcuTarget system in eye care centers across Asia and Europe. As a treatment option for near vision loss, or presbyopia, the Kamra corneal inlay is designed to create a small aperture effect for the eye, allowing patients to see near and intermediate objects more clearly. The AcuTarget system is a technology used to guide surgeons on proper surgical placement of the Kamra inlay. The Kamra inlay is an intra-corneal inlay designed to create a small aperture effect, allowing the eye to see near and intermediate objects more clearly. By applying the “depth-of-focus“ principle commonly used in photography, the Kamra inlay controls light transmission allowing only central rays to reach the retina through a fixed 1.6 mm aperture. The Kamra inlay is placed under a LASIK-type flap using the AcuTarget System.

• Advanced Vertebral Solutions (Doylestown, Pennsylvania) received FDA clearance for its new Steerable TLIF spinal fusion implant made of Zeniva polyetheretherketone (PEEK) resin from Solvay Advanced Polymers (Alpharetta, Georgia). Zeniva PEEK – part of Solvay's Solviva line of biomaterials – has a modulus very close to that of bone plus toughness and fatigue resistance. The FDA clearance was based in part on Solvay's master access file for Zeniva PEEK. The Express IBFD TLIF implant, made from 30- and 40-mm-diameter Zeniva PEEK rod stock, is an implant for interbody fusion of the anterior column of the spine. These implants are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae.

• American Medical Systems (AMS; Minnetonka, Minnesota) reported the launch of its MoXy Liquid Cooled Fiber for laser treatment of benign prostatic hyperplasia, or enlarged prostate. Designed to be used with the recently launched GreenLight XPS (Xcelerated Performance System) 180 Watt laser, the MoXy fiber, with its Active Cooling Cap technology, uses 360-degree saline flow to maintain the temperature of the fiber tip for increased fiber longevity. The new system maintains the same safety profile as the GreenLight HPS and PV systems.

• Collagen Matrix (Franklin Lakes, New Jersey) received FDA clearance of a new Collagen Dental Membrane derived from porcine dermis indicated for use in oral surgical procedures involving guided tissue and bone regeneration. This membrane is a nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from porcine dermis. The purification process results in a purified intact collagen tissue membrane with negligible non-collagenous materials. The significance of the new technology is the use of porcine tissue rich in collagen, whereby the treatment eliminates most, if not all, of the non-collagenous materials resulting in a highly purified intact collagen matrix. This treatment maintains the intact collagen framework while eliminating associated non-collagenous materials, the company said.

• Concentric Medical (Mountain View, California) reported the start of the TREVO study. The TREVO study (T hrombectomy RE vascularization of large V essel O cclusions in acute ischemic stroke) is the first to evaluate Stentriever technology in a European, multicenter, prospective trial. TREVO is designed to assess the ability of the Trevo system to remove the blood clots that cause strokes and to restore blood flow to the brain. The Trevo system is a thrombus retrieval system that uses Stentriever technology and creates a new generation of retrieval devices to remove clot in ischemic stroke patients.

• DFine (San Jose, California) reported FDA clearance of a new platform extension indicated for the palliative treatment of cancer patients. The product, a percutaneous radio frequency ablation (RFA) device, provides localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine causing severe pain and discomfort. Beyond narcotic administration, the primary modality for treating painful spinal metastases is external beam radiation which when effective, may require weeks or months to address the associated pain and disability. In addition, radiation therapy often requires that patients suspend chemotherapy treatment of the primary cancer due to cumulative toxicity. The ability to provide localized RFA of metastatic lesions of the spine can provide immediate and lasting pain relief, allowing these patients an improved quality of life and minimal, if any, delay in systemic, curative therapy of their primary cancer.

• DiFusion Technologies (Austin, Texas) reported FDA clearance of its new Xiphos line of posterior interbody devices indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. The Xiphos System of implants is also indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The system is intended for the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. DiFusion Technologies is a medical device company focused on its CleanFuze anti-microbial technology for orthopedic implants.

• Estech (San Ramon, California) reported the launch of its Cobra Revolution Bipolar Clamp for use in surgical ablation procedures. The company said this new instrument enables deep transmural lesion formation after a single application and is the only clamp to feature reversible jaws, which uniquely allows surgeons to follow anatomic contours, for unprecedented ease of use and efficiency. The Cobra Revolution Bipolar Clamp is the latest addition to Estech's Cobra ablation product line, which features the company's patented temperature-controlled radio frequency (TCRF) technology for superior patient safety and clinical effectiveness. The Cobra Adhere XL, Cobra Cooled and Cobra Surgical probes have been cleared for cardiac ablation. The AFfirm Pacing Probe has been cleared to be used upon completion of the cardiac ablation procedure to assess the adequacy of cardiac lesions created in surgically treating the patient's arrhythmia.

• Hill-Rom (Batesville, Indiana) reported the introduction of the Hill-Rom P500 Therapy Surface with new treatment features and added versatility, now making it compatible with most flat deck bed systems. Hill Rom says the P500 Therapy Surface offers a mix of key features, including: Weight-based pressure redistribution supporting patients up to 500 pounds; Advanced Microclimate Technology, which is the most advanced low air loss system available; Turn Assist with “confirm rails up“ feature to aid the caregiver in turning the patient left or right; Audible and visual Bed Exit, 30-degree Head-of-Bed and RemindMe alarms to help reduce the risk of caregiver and patient injury; and Shear-resistant material and a real-time pressure redistribution algorithm that offers shear and friction management, protecting the skin.

• Integra LifeSciences (Plainsboro, New Jersey) reported market introduction of the Integra Total Wrist Fusion System. The Integra Total Wrist Fusion System is the latest addition to Integra's suite of solutions for wrist arthritis. Wrist fusion is a surgical procedure intended to reduce pain resulting from joint diseases, including arthritis of the wrist, particularly osteoarthritis and rheumatoid arthritis. The procedure fuses the bones at the wrist joint and may ease the pain caused by bone on bone contact. Integra's Total Wrist Fusion system is designed to provide fixation of the wrist, while decreasing soft tissue irritation, and provides an optimal balance of compression and stability by combining Surfix locking and dynamic compression technologies. Surfix locking technology allows the surgeon to fully seat the screw in the plate prior to locking the screw in place.

• Orthofix International (Boston) reported the launch of a new spinal deformity correction module based on the Firebird pedicle screw system which its Spinal Implants Division introduced last year. The design of the system's new Direct Vertebral Rotation (DVR) device provides surgeons with the opportunity to combine rod reduction and direct vertebral rotation in one low profile instrument, and is also intended to provide quicker intraoperative assembly and disassembly when compared to other deformity correction systems available. The new Firebird deformity correction module is currently in limited market release, and Orthofix expects to begin its full market release during 1Q11.

• Orthovita (Malvern, Pennsylvania) received FDA clearance to market Vitomatrix bone graft substitute as a bone grafting material in certain dental procedures. Vitomatrix is a resorbable, highly porous synthetic scaffold that uses the core technology from the Vitoss bone graft substitute product line. Vitomatrix is indicated for use in procedures to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. An estimated 375,000 procedures are performed domestically each year where Vitomatrix can be used. Orthovita's orthobiologics platform offers products for the fusion, regeneration and fixation of human bone.

• PolyRemedy (Boston) received FDA approval for its antimicrobial dressings. PolyRemedy's PolyFIT antimicrobial dressings promote an enhanced wound healing environment without causing resistance to specific bacteria for which they are targeted. Embedded with a 0.3% concentration of Polyhexamethylene Biguanide (PHMB), PolyFIT dressings are specifically designed for managing wound exudate and microbial proliferation within the dressing, while maintaining a moist wound environment. PHMB is bonded to PolyRemedy micro-fibers to ensure an optimal healing environment while reducing bioburden. Customized dressings comprise the therapeutic portion of PolyRemedy's integrated Personalized Woundcare System (PWS) that also includes expert, protocol-driven wound assessment and dressing selection tools, as well as real-time feedback and alert notification throughout the wound healing process. PWS allows clinicians and nurse managers to monitor patient progress, respond to clinical alerts and changes in wound trajectory, and communicate effectively with referring physicians and primary care physicians, the company said.

• RepRegen (London) reported that three- and six-month data from an in vivo study of its CE-marked StronBone bone graft substitute with strontium demonstrated by analytical testing that it can generate bone quality in, and around, bone defects that is significantly superior to a standard bone void filler (TCP-CaSO4) in the control defect. Specifically, the study demonstrated: The bone in the defect was significantly stiffer (stronger) at three months (69%) in the StronBone bone graft than in the control (it took six months for the control to achieve a comparable stiffness); and, the bone in the defect was significantly denser at three months (41%) and six months (62%) in the StronBone bone graft than in the control.

• RyMed Technologies (Franklin, Tennessee) said a lengthy study performed at Methodist Extended Care Hospital (Memphis, Tennessee) resulted in the elimination of potentially deadly infections. The Methodist study showed that an intraluminal protection IV needleless connector was dramatically more effective than two other connector designs in preventing central-line-associated bloodstream infections (CLABSIs). This type of connector prevents dangerous microorganisms from collecting in the connector and catheter. The hospital, a long-term acute care facility, tested three different IV connector designs because research shows that connectors can play a critical role in causing or preventing CLABSIs. The study confirmed that the intraluminal protection design helps to prevent infections. Certain other designs are associated with much higher infection rates. The three connector types tested in the study were a split septum connector; negative pressure mechanical valve; and the intraluminal protection connector (IP). The IP was the only connector that produced an acceptable rate by today's standards: 0.49/1,000 catheter days, including a zero rate (no infections) for the final 10 months of the test period. The IP connector is called the InVision-Plus, made by RyMed.

• Sanomedics (Miami) said that it will be introducing the BabyTemp “TouchFree“ talking baby and child thermometer for use with children of all ages. The BabyTemp “TouchFree“ talking thermometer does not require probes, strips or invasive action. Available in three languages, English, Spanish and French, readings are displayed within seconds on a large visual display or spoken aloud. With the 32 measurement memory, adults can provide a history of temperature variation when they seek additional medical care. Because BabyTemp is “TouchFree“, this thermometer helps to avoid the spread of illness between children and family members by limiting contact and cross-contamination. Sanomedics makes professional medical, as well as, home health diagnostic devices and products.

• Siemens Molecular Imaging (Malvern, Pennsylvania) reported the launch of the HD•Chest – a new technology that reduces blur created by respiration during PET/CT studies. The latest evolution in Siemens high-definition PET technologies, HD•Chest provides full high definition (HD) lesion detection and improved SUV quantification for PET/CT study. More than 90% of today's PET/CT studies are whole-body scans that can be used to investigate the presence of small lesions in the chest or upper abdomen. By providing a highly automated, amplitude-based gating technology, HD•Chest images the chest and upper abdomen in high-definition and eliminates the fundamental problems encountered with phase-based 4-D gating, which can be disruptive and time consuming. Siemens says HD•Chest is an innovative combination of hardware and software, that provides an accurate, sharp image as respiratory motion is frozen. It also encourages an easy workflow for the routine evaluation of chest and upper abdomen lesions, providing additional clinical value with every patient study.

• Titan Spine (Mequon, Wisconsin) said that it will begin full commercial release of its new Endoskeleton TC system in 1Q11. The Endoskeleton TC is an interbody fusion device for the cervical spine. The product FDA clearance in July of this year and has been in limited market release since early August. The device has an acid etched titanium surface and is biomechanically designed to promote spinal fusion.

• Urovalve (Newark, New Jersey) said that early results are promising in a multi-site clinical study of the company's Surinate bladder management system. The system is designed to improve the quality of life and health of men who suffer from acute or chronic urinary retention, an inability to empty the bladder. Proper insertion of the Surinate catheter was successful in thirteen of the first fourteen subjects enrolled in the study. All 13 subjects were able to properly position and actuate the Surinate device and empty their bladder successfully and use the Surinate device successfully for more than 24 hours. Surinate is designed with a magnetic valve inside the catheter that allows the bladder to fill and then empty only on manual control by the patient. The patient uses an external magnet to open the valve in the Surinate catheter to drain the bladder only when he needs to.

• Wenzel Spine (Austin, Texas) reported FDA clearance to market the VariLift Expandable Interbody Fusion System for stand-alone use. The VariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. VariLift-L is designed to be implanted as a single device via a transverse approach or bilaterally via a posterior approach. VariLift-A is designed to be implanted bilaterally via an anterior approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

• W. L. Gore & Associates (Newark, Delaware) reported the availability of larger sized Gore BIO-A Tissue Reinforcement, an alternative to biologics for reinforcement of soft tissue in surgical procedures. Gore BIO-A Tissue Reinforcement is a non-biologic scaffold that is gradually absorbed by the body. The open, highly interconnected 3-D pore structure facilitates rapid cell infiltration and vascularization. Since Gore BIO-A Tissue Reinforcement is not derived from biologic tissue; there is no risk of disease transfer like those associated with human or animal tissue. Due to the synthetic nature of Gore BIO-A Tissue Reinforcement, surgeons see an additional advantage over biologics in the product's uniformity, thickness, and consistency, the company said. Gore BIO-A Tissue Reinforcement is intended for use in the reinforcement of soft tissue, including hernia repair (in non-load bearing applications), muscle flap reinforcement and general tissue reconstructions. More specific applications include: stoma reversal, paraesophageal/hiatal hernia repair, breast reconstruction using pedicled TRAM flap, abdominoperineal resection and abdominal wall reconstruction.