BB&T

Carticept Medical (Alpharetta, Georgia) is increasing the accuracy of its Navigator Delivery System, a drug delivery application, with the addition of an ultrasound component. The med-tech startup said that it had received FDA clearance to market the device with the addition of ultrasound guidance.

The company says that the newly integrated application will help to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.

“It's been a fairly lengthy development cycle and it's required a couple of rounds of investment from our venture capital partners but we're delighted we're now on the cusp of commercializing the product,“ said Tim Patrick, CEO of Carticept.

Patrick noted that the company has raised $43 million since its inception.

The device is a computer-controlled, drug delivery system designed to automate preparation and delivery of pain relieving medications for joint pain. The system prepares physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials.

In addition to eliminating multiple needle exposures to healthcare workers and minimizing the potential for contamination of the medication, automating this procedure ensures accurate dose preparation and saves significant labor for a busy physician practice. The injection is then delivered into the painful joint under precise computer control. The Navigator DS automates accurate medical record keeping by recording the treatment data for transfer to an electronic record management system or direct print-out.

“In the previous iteration we had a system that would help us hold the data, the standard vial, and prepare those doses at the request of the physician by moving a foot pedal,“ Patrick told Biomedical Business & Technology. “The use of ultrasound with the device is really a great benefit as it relates to the efficiency and accuracy of filling that dose. Ultrasound has been used to accurately locate the tip of the needle in the tissue and there have been a lot of studies that have been done that show when you have ultrasound guidance vs. no guidance that clinicians are able to do a significantly better job of guiding that needle where it needs to be.“

He added that “for the first time ever we've got these two systems that are sharing information together.“

“When a physician is performing an ultrasound injection with the integrated system, they're looking at an image of the drug syringe on top of the ultrasound screen. It shows how much drug remains to be delivered,“ he said. “It shows them the inline pressure and it also tells them the drugs that are being delivered and captures that information automatically. So all of the demographic info that would have been available for them on the ultrasound and all of the information that would be available to them on the Navigator is now available to them automatically sequenced together and stored for them.“

The ultrasound component of the device was manufactured by Sonosite (Bothell, Washington), an equity investor in the company, and has already been cleared by the FDA. The company had to get an additional clearance for the combination of both devices.

Carticept has CE mark approval for two generations of the device, with the latest including an ultrasound component. The device hasn't yet been launched in Europe, but has been introduced to a number of sites in the UK, the company notes.

The firm plans to launch the device in early 2012.

The company which was founded in 2005, according to its website, also has started a multi-center study of its Cartiva Synthetic Cartilage Implant (SCI). The study aims to determine the effectiveness of Cartiva SCI in comparison to arthrodesis (joint fusion), the current standard of care, for reducing the debilitating pain associated with osteoarthritis of the first metatarsophalangeal joint.

Cartiva SCI is a polyvinyl alcohol cryogel device designed to mimic natural cartilage. The device is intended to maintain natural joint mechanics by repairing focal cartilage defects while minimizing the resection of healthy tissue. Due to its similar properties to native cartilage, joint resurfacing with Cartiva SCI does not require replacement of the opposing surface. It is expected that patients may be able to return to normal activities more quickly than when treated with joint fusion.

Brainlab (Munich, Germany) reported the launch of Curve Image Guided Surgery. Curve features image-guidance software using advanced 3-D displays and Brainlab image enrichment. This technology allows fast image updating when tracking instruments, which promotes intra-operative confidence. Using a human-centered design approach, Brainlab sets out to challenge conventional surgical utility and incorporate great ergonomics, two game-changing, multi-directional touch terminals, digital HD, hi-fi and wi-fi. The company says additional new features include: cameras with motorized adjustment, telescopic stand and laser pointer for unbelievable setup flexibility, extended camera tracking volume multiplies setup options without compromising patient registration, digital, human-factor design hub connects Curve to the outside world and rapidly integrates third-party surgical devices.

BSD Medical (Salt Lake City) said the company's line of hyperthermia products were featured at its exhibition booth at ECCO's Multidisciplinary Cancer Congress held last month. The BSD-2000/3D/MR is the integration of a sophisticated hyperthermia therapy system with an advanced magnetic resonance imaging system from Siemens Healthcare. The integrated system introduces a new use of MR imaging, expanding MR use from its traditional role in diagnostic imaging to real-time imaging and monitoring of cancer treatments.

Christie Medical Holdings (Memphis, Tennessee) reported results from its study on the VeinViewer Vision device's TrueView imaging. The study shows that TrueView produces a 97% accurate vein image, which is critical for assisting clinicians in choosing the appropriate catheter gauge, and is exclusive to VeinViewer Vision family of products. VeinViewer uses near-infrared light and other technologies to project a real-time digital image of subcutaneous vasculature and blood patterns directly onto the surface of the skin. Although designed for assistance in IV starts and blood draws, VeinViewer also is proven to be beneficial in the process of spider and varicose vein treatment.

CJPS Medical Systems (Auburn Hills, Michigan) said it is releasing the smallest, most featured, lowest cost, portable multi-parameter vital signs monitor on the market. The monitor, the VitalPoint PRO, is half the price of its closest competitors, the company said. The VitalPoint PRO measures approximately 11“x 7“x 2“ with a total weight of 4.5 lbs. This clinical version of VitalPoint is truly portable and, with its 5-hour battery life, can stay with patients as they move through healthcare facilities, can be used at clinics and surgical centers, as well as by visiting nurses and physicians or in emergency vehicles. VitalPoint PRO is able to monitor arrhythmia, to measure blood pressure, blood oxygen saturation, pulse rate, respiration rate, heart rate, and temperature, and to provide electrocardiogram data.

Erchonia (McKinney, Texas) a maker of low-level laser healthcare applications, reported the results of a new study which showed that its Zerona laser is effective in non-invasively reducing the circumference of the upper arms, a difficult area to treat through diet, exercise or even surgery. Already FDA-approved for the non-invasive body contouring of the waist, hips and thighs, the Zerona laser showed significant effectiveness in treating upper arms in a recent 40-subject, double-blind, randomized, sham-controlled clinical study. All subjects were treated with a total of 6 treatments with either the Zerona 635 nm low-level laser or a sham laser device over a two-week period. Upon completion of the treatments and at two weeks post-treatment, the active treatment group showed approximately a 4 cm combined reduction in the bilateral circumference, and the sham treatment group showed essentially no change.

• Genomic Health (Redwood City, California) said Palmetto GBA, the designated national contractor for its Oncotype DX colon cancer test, has established a formal coverage policy for all Medicare patients. The Oncotype DX colon cancer test has been clinically validated to predict risk of recurrence in patients with stage II colon cancer. The policy covers men and women with stage II colon cancer. The company says the Oncotype DX colon cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer. Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and Cleveland Clinic on a total of four development studies in more than 1,800 to analyze patients with stage II colon cancer.

HeartWare International (Framingham, Massachusetts) reported updated clinical data from its bridge to heart transplantation (BTT) study, ADVANCE, and the Continued Access Protocol (CAP). The updated data for 241 patients enrolled in either the pivotal trial ADVANCE or CAP demonstrates a 180-day survival of 93%. The HeartWare Ventricular Assist System features the HVAD pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HVAD pump weighs almost 5 ounces and displaces a volume of about 50 milliliters. Other observations reported during the presentation include: only 21.6% of study patients had received a transplant at the six-month endpoint, reflecting longer waiting times for heart transplantation; reduction in the rate of pump exchange for suspected thrombus to less than 0.03 events per patient year, since an adjustment in anticoagulation in March; reoperations for bleeding and sepsis, and driveline infections were notably infrequent.

• Integra LifeSciences Holdings (Plainsboro, New Jersey) reported the introduction of the Cordant Anterior Cervical Plating system, expanding Integra's spine product portfolio to include three anterior cervical plating solutions. The Cordant Anterior Cervical Plating System provides temporary stability during spinal fusion procedures for patients suffering from disc disease or trauma. The Cordant system features a narrow hour-glass plate design, which provides excellent lateral graft visualization and potentially reduces the amount of tissue retraction required for implantation. This plate design may provide a better fit for smaller stature patients. The novel tri-cam locking mechanism and instrumentation provide a streamlined approach to anterior cervical fusion. The screwdriver handle is ergonomically designed with three flats that are orientated to the three flats on the locking screw head.

• Kimberly-Clark Health Care (KCHC; Roswell, Georgia) has received FDA clearance to market the Kimberly-Clark Child's Face Mask. The company says this marks the first time that the FDA has granted any manufacturer 510(k) clearance for a pediatric face mask and establishes the product with the designation of a Class II medical device. The company describes the face mask as a single-use device that is intended to be worn by children ages 5-12 to provide protection for the respiratory tract, and has been specifically designed to fit small faces to maximize effectiveness, comfort and compliance. Featuring colorful Disney characters on its outer-facing panel to create familiarity and appeal, the mask is intended for use in healthcare settings such as waiting areas and exam rooms to protect children who may be at increased risk for infection. These include children who are already ill, immuno-compromised, displaying flu-like symptoms, potentially contagious while visiting a patient family member, or having a routine check-up during flu season or a pandemic outbreak.

• Medical Alarm Concepts Holding (King of Prussia, Pennsylvania) said that it is beta testing its next-generation medical alarm, and hopes to release the new product sometime next year. The new MediPendant will have enhanced features, including but not limited to, a rechargeable battery, a pendant locator, and wireless and cellular capabilities. In addition, the product will be sleeker in design and 25% smaller than the current device. A standard personal emergency response system (PERS) does not enable the user to speak and listen through the pendant, thus limiting them to a small area in their home. There is always the risk that the user will not be heard by the call center operator if they are not within range of the base station. MediPendant's two-way voice technology enables the user to speak and listen directly through the pendant no matter where they may be in and around their home. MediPendant service also includes advanced features such as multi-party voice sessions that enable the operator to link loved ones directly into the emergency call in real time, so they can be a part of the actual emergency call.

• North American Spine (Dallas) reported the introduction of the AccuraScope procedure, which diagnoses and treats back pain with real time visualization. It has the capability to uncover problem areas not visible in an MRI such as acute and chronic inflammation, especially around torn or herniated discs and subsequent scarring due to these inflammation changes and torn disc disruptions. The Journal of Neurosurgical Review has just published an in-depth survey of the various types of minimally invasive back surgeries including the AccuraScope procedure (epidural endoscopic disc and neural decompression). In this review, this minimally invasive approach is reported to effectively improve patients with back and leg pain more than 80% of the time. The 45-60 minute procedure begins with a tiny incision at the sacral hiatus – the tail bone – which allows a flexible endoscope to move through the entire anterior lumbar epidural space, checking for herniated or bulging discs, and spinal stenosis (narrowing of the spine around the neural elements), degenerative disc disease and other problems that cause back pain. Patients are usually up and around the day of surgery and return to normal activity, including exercise, within a couple of weeks.

Nucletron (Veenendaal, the Netherlands) received FDA clearance for its new Vaginal CT/MR Multi Channel (VCMC) applicator, offering a brachytherapy solution that enables very precise dose delivery for gynecologic cancers. The company says the VCMC applicator provides accurate target coverage and maximizes conformity in the treatment of gynecologic cancers. It features Nucletron's precise dose delivery solution technology, a system that loads several source channels in the applicator, with a unique catheter geometry. This results in a dwell position that is very close to the target area, allowing for greater treatment precision. The company claims the VCMC applicator is easy to assemble, clean and sterilize and integrates seamlessly with Nucletron's Oncentra treatment planning software. Automatic reconstruction of the exact geometry of the applicator dramatically improves the speed of planning, and ensures precise and reproducible placement of the applicator.

• Siemens Healthcare (Malvern, Pennsylvania) said the Mobilett Mira, the company's first mobile digital X-ray system with a wireless detector, recently received FDA clearance and is now available in the U.S. The Mira's wireless capability facilitates examinations of patients with limited mobility, and its rotating swivel arm helps increase ease of use for clinical staff. Mobile X-ray systems are used frequently when patients cannot be moved to an X-ray room – for example, when they are in the intensive care unit. Until now, a mobile unit's X-ray detector was connected to the system via a data cable that could lengthen the exam process, cause patient discomfort, and hamper the imaging efforts of clinical staff. With the Mobilett Mira, Siemens says it combines the advantages of mobile X-ray imaging with the flexibility of a wireless detector.

• Porex (Fairburn, Georgia) has launched a line of glass fiber designed to deliver precision, accuracy and reliability when used in the most challenging filtration, separation, extraction and purification procedures. Manufactured in various particle retention sizes and thicknesses, Porex BioDesign Glass Fiber helps prevent premature clogging and compromising flow rates when processing large volumes and challenging solutions. The company says it can be used in a wide array of life science and diagnostic applications including spin columns, assay plates, purification kits and IVD sample wicks, absorbent pads and conjugate release.

Ventana Medical Systems (Tucson, Arizona) received FDA clearance for the anti-Helicobacter pylori (SP48) rabbit monoclonal primary antibody. The Ventana H. pylori antibody provides pathologists unprecedented views of the bacterium, allowing for a more accurate patient diagnosis. The high contrast staining of the organisms allows pathologists to view more bacteria than can be detected with special stains. With the H. pylori antibody, a pathologist can view the characteristic helical shape of the organism. Even when very few organisms are present, an infection can be detected and treated effectively.

• Zynex (Lone Tree, Colorado) received FDA clearance on its NexWave medical device. The NexWave device is an electrotherapy treatment and will be manufactured, marketed and sold through a Zynex subsidiary. This device is capable of delivering three modalities of stimulation; traditional TENS, interferential and neuromuscular electrical stimulation. The combined modalities of the NexWave provide a wide variety of pain and muscle rehabilitation therapies through one device. Zynex makes its own design of electrotherapy medical devices for standard digital electrotherapy, used for pain relief, pain management and stroke and spinal cord injury rehabilitation.