BB&T, and Staff reports

A bionic foot that replicates a natural human walking gait has, to date, been used primarily for members of the military. Further refined and now available to the general public, the Proprio Foot is likely to change the prosthetic landscape.

"It's the technology of the future," said prosthetist Joe Reda, CPO, who is among the first technicians in the U.S. to be certified in the fitting of this device. "One of my first patients, a motorcycle rider, wore it on his bike to Sturgis Motorcycle Rally this week."

Reda is an assistant director at Kessler Institute for Rehabilitation (West Orange, New Jersey), one of the first rehabilitation centers in the country to offer the Proprio Foot developed by Ossur (Reykjavik, Iceland).

"It's the only computerized foot on the market," Reda told BB&T. "The biggest limiting factor is the cost right now and reimbursement."

With a price tag of $34,000, it's a bigger commitment than other foot prosthetics, which range in price from $5,000 to $18,000.

The artificially intelligent prosthesis for transtibial amputees operates like natural, anatomical functioning. Developed by Ossur's R&D department, the foot's motion analysis capabilities are facilitated by real-time sensor technology from Dynastream Innovations (Cochrane, Alberta).

The foot's name is derived from its ability to detect where the foot is in space, known as proprioception.

"It's got tilt sensors," Reda said. "It analyzes what the patient is doing and picks the toe up to allow the foot to clear the ground easier. Going up an incline, an amputee would generally walk on his toes and then down an incline on the heels because a regular prosthetic foot doesn't have the flexibility. With the Proprio, after the second step it flexes the foot going up, so the patient does a natural heel-to-toe gait. On the decline it does the same thing. When amputees go from sitting to standing, they usually use their good leg only, but with this foot, it flexes more so they can use both feet."

The Proprio includes sensor technology that mimics the body's own neural receptors that are sensitive to mechanical change, providing artificial proprioception — the sense of where the limb is in space, according to Ossur. The artificial intelligence (AI) processes information from those sensors and activates the most appropriate response for the next step. The AI transmits an ongoing stream of signals that instruct precise actuator technology to act and deliver optimal function.

It works unlike any other prosthetic limb Reda has ever used. But it lacks any cosmetic attributes.

"It's not a cosmetic leg by any stretch of the imagination. It's fairly bulky," said Reda, who is not affiliated with Ossur. "The ankle weighs 2 to 2.5 pounds with a large battery pack located on back of the socket. You can't cover it. But the function of the foot outweighs the cosmetic aspect."

Designed for below-the-knee amputees, Proprio requires some basic programming when fitted with a patient that takes about 45 minutes. The battery stays charged for 36 hours before recharging is required.

"The technology is there," Reda said. "I'd like to see a smaller battery and unit."

He added that while the foot is not intended for athletic use such as running, it is designed for active people.

Until now, the Department of Defense and the U.S. Department of Veterans Administration have actively used the foot to benefit service men and women returning from the Iraq and Afghanistan conflicts, as well as veterans of past wars, according to Ossur.

The company is currently working to obtain Medicare reimbursement coding.

Elsewhere in the product pipeline:

• Bovie Medical (Melville, New York) has filed a 510(k) FDA submission to begin marketing the ICON VS electrosurgical generator. The generator has been designed to work with Bovie's Seal-N-Cut line of vessel sealing instruments providing both monopolar and bipolar energy options to the surgeon. The fully digital ICON VS generator has a user friendly interface allowing the surgeon flexibility to choose the type of effect desired. The monopolar and bipolar functions satisfy a wide variety of surgical demands needed during surgeries including vessel sealing. Bovie also received FDA clearance for the J-Plasma ICON GS electrosurgical generator and hand piece. The technology uses a gas ionization process producing a stable thin focused beam of ionized helium gas that can be controlled in a range of temperatures and intensities, providing the surgeon greater precision, minimal invasiveness and an absence of conductive currents during surgery. Independent control of the beam power (heating) and helium flow rate (cooling) produces a localized effect with minimal collateral damage to the surrounding healthy tissue.

• BrainScope (Washington) said its first device, the Zoom-100DC brain electrical activity data collection system, has received FDA clearance. The Zoom-100DC is an 8-channel, portable, handheld electroencephalogram (EEG) device capable of recording and displaying EEG waveforms and providing conventional EEG measures displayed in tables. The Zoom-100DC is designed to be used at the initial point of care where traditional EEG tools are not readily available. It is intended to monitor the state of the brain by acquisition and display of EEG signals and by the calculation of standard quantitative EEG (qEEG) parameters.

• Celerus Diagnostics (Carpinteria, California) reported that it will introduce a totally automated immunohistochemistry (IHC) staining system to the market next year. According to CEO David Gross, the new Wave RPD, will provide laboratory results faster and more flexibly than anything known to the industry. "The key is uniting total automation with our existing rapid staining system," he said. "No manual pretreatment will be required, as is necessary with many existing legacy staining platforms." Celerus Diagnostics introduced Rapid IHC with its Wave System in 2008. In addition to standard IHC applications, breast, neuro and Mohs surgeons benefit significantly from intraoperative results made possible in just 15 minutes.

• Cochlear Americas (Denver) said that the FDA has cleared the Cochlear Baha BP100 Sound Processor, a programmable bone conduction hearing solution. The Baha BP100 is designed for people with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness. The Baha BP100 features a bone-anchored hearing solution with automatic digital signal processing. The automatic signal processing functions automatically adapt to the user's sound environment, helping to provide greater audibility and listening comfort across different listening environments. The Baha system sends external sounds to the inner ear through the bone by passing the outer and middle ear. Bone-anchored hearing solutions are designed to provide audibility and to improve the communication abilities of those who receive little or no benefit from hearing aids.

• ConvaTec (Skillman, New Jersey) reported the launch of a new campaign and best practice statement supporting Versiva XC gelling foam dressing. The Versiva XC is the only cover dressing to contain ConvaTec's Hydrofiber Technology; and the company claims the Versiva XC dressing transforms wounds through its unique gelling action. This action enables dressings containing Hydrofiber Technology to lock in exudates and its harmful components and contour closely to the wound bed, in response to changing wound conditions. ConvaTec dressings with Hydrofiber Technology gel on contact with fluid, providing clinicians and patients with substantial wound care benefits.

• Covidien (Boulder, Colorado) said it has received FDA clearance to market its Leak Compensation software feature for the Puritan Bennett 840 ventilator system. This option provides continuous levels of mechanical ventilation to patients requiring respiratory support, regardless of the level of gas leakage that might occur in the circuit or past a patient interface device in the clinical setting. During either invasive or noninvasive ventilation, air leaks past a mask, nasal prongs, nasal pillow, supraglottic airway, endotracheal tube or tracheostomy tube can result in loss of gas volume, potentially causing subsequent dysynchrony between a patient's spontaneous breathing efforts and the ventilator's response.

• Electro-Optical Sciences (Irvington, New York) said the FDA accepted its PMA application for MelaFind, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. EOS designed MelaFind to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.

• Ethicon (Somerville, New Jersey) said that its Biopatch protective disk with CHG (chlorhexidine gluconate) will include new design elements and updated packaging to make it easier for surgeons, nurses and other healthcare providers to apply the product correctly around catheters to reduce the risk of catheter-related bloodstream infections (CRBSIs). Biopatch is placed directly on the skin at the point of catheter insertion and provides seven days of continuous active antisepsis. In a clinical study, the use of Biopatch was associated with a 76% reduction in CRBSI.

• Helicos BioSciences (Cambridge, Massachusetts) reported the publication of a study in which a Helicos Genetic Analysis System was used to sequence a human genome at the Stanford Institute for Stem Cell and Regenerative Medicine. The study was carried out using less than four runs of a single HeliScope Single Molecule Sequencer, and achieved 28X average coverage of the human genome. The sequencing allowed the detection of over 2.8 million single nucleotide polymorphisms (SNPs), of which more than 370,000 were novel. The Helicos Genetic Analysis System is a single molecule sequencing technology, and enables scientists to conduct studies in the fields of genome biology, cancer research, common diseases genetics, and microbiology without adapter ligation or amplification. The Helicos Genetic Analysis System can analyze DNA directly, with very little manipulation, allowing individual laboratories to conduct affordable, large-scale experiments.

• InfoLogix (Hatboro, Pennsylvania) reported the introduction of a new mobility offering for healthcare providers, the InfoLogix M24 mobile clinical assistant: a powerful mobile computing solution that enables medical professionals to access critical patient information at the point-of-care. The InfoLogix M24 is built upon the Intel mobile clinical assistant reference architecture, which is designed specifically for healthcare and the rigors of the clinical environment, including integrated technologies that support the "five rights" of medication administration and provide more streamlined and efficient workflows. Also, the InfoLogix M24 features an array of technologies such as a bar code scanner, a Radio Frequency Identification (RFID) reader, a fingerprint reader, a webcam, and a microphone array. InfoLogix says these innovative tools enable hospital staff to access valuable patient data quickly and easily which can help reduce the number of errors and allow clinicians to spend more quality time with patients.

• Kinetic Concepts (San Antonio) reported the launch of the ABThera open abdomen negative pressure therapy system, the latest addition to its Negative Pressure Technology Platform (NPTP). ABThera is designed to assist surgeons in the management and treatment of "open abdomen" and to help achieve primary fascial closure. The ABThera system is indicated for temporary bridging of abdominal wall openings where primary closure is not possible or repeat abdominal entries are necessary. The system's intended use is in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.

• Lifeline Biotechnologies (Reno, Nevada) said that it has made its initial filing of its First Warning System with the FDA. Jim Holmes, Lifeline's CEO went on to say, "This is a very exciting time for us and those that are interested in this innovative, leading edge, and disruptive technology. The First Warning System is a device and process which assists in the early detection of breast cancer, designed, developed and tested with approximately 700 women. This process has the potential of changing the way breast cancer is identified. After many years and many resources applied, we've moved to the important point of entering the process of clearance of this device with the FDA. The next step is expected to be obtaining clearance for market entry."

• Mesynthes (Wellington, New Zealand) said it has filed a PMA application for the company's Endoform Dermal Template for use in the treatment of chronic wounds including diabetic foot ulcers. Endoform provides a mix of biologic macromolecules that actively promote cell proliferation and angiogenesis (blood vessel formation) to improve wound healing. The Endoform technology uses an extracellular matrix that contains a complex mix of important biological molecules. The Dermal Template is presented as a lyophilized product in a sterile pouch, is strong and easy to handle in a dry or hydrated state. The wound matrix is applied to the wound bed, then rehydrated, covered with a non-adherent dressing, and secured in place.

• Picis (Wakefield, Massachusetts) said that it supports First DataBank's National Drug Data File (NDDF) Plus as a native medication database within Picis ED PulseCheck, the company's emergency department information system (EDIS). Picis says that by embedding First DataBank drug databases within ED PulseCheck, emergency department (ED) clinicians have a greater ability to exchange patient medication and allergy information with other hospital information systems that rely on First DataBank for their drug and allergy clinical decision support. Picis says the ED PulseCheck, part of the CareSuite family of high-acuity solutions, provides physicians and nurses with a comprehensive snapshot of the entire ED with quick access to patient information – such as demographics, laboratory and radiology results – and interoperability with existing hospital information systems.

• Spiration (Redmond, Washington) said the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for IBV Valve System use in the hospital inpatient setting to control prolonged air leaks or air leaks likely to become prolonged following lobectomy, segmentectomy or lung volume reduction surgery. The new technology add-on payment is used by CMS as a means to correct for inadequate payment of new technologies under the existing Medicare payment groupings, called Medicare Severity Diagnosis Related Groups (MS-DRGs). CMS regulation considers the NTAP "additional payment when it represents an advance in medical technology that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries."

• Titan Spine (Mequon, Wisconsin) said that it began limited market release of its Endoskeleton TT system, a new transforaminal lumbar interbody fusion (TLIF) device. The Endoskeleton TT is indicated for use in adults with degenerative disc disease in the lumbar spine. Steve Cichy, VP of sales and marketing for Titan Spine, says, "As with the Endoskeleton ALIF device, the ability to have greater surface area contact clearly resonates with the surgeon when discussing contact to the endplates. Furthermore, the opportunity to utilize the TLIF device as a stabilizer of the motion segment as opposed to a spacer allows the surgeon to have the interbody device take part in the fusion process."

• Vicor Technologies (Boca Raton, Florida) said that the U.S. Army Institute of Surgical Research (USAISR), will present findings from trials of Vicor's PD2i VS (Vital Sign) that have been performed under a collaborative agreement between Vicor and the USAISR at Smart Monitoring 2009. The two presentations will a) detail the use of Vicor's PD2i VS as a new vital sign diagnostic that more accurately risk stratifies trauma severity and the probability of survival in the critically injured, and b) provide a review of findings from trials conducted under the Collaborative Research and Development Agreement (CRADA) between Vicor and the USAISR begun in January 2008.