Diagnostic systems continue to shrink, very notably those allowing physicians dealing with gastrointestinal issues to get a close look at the goings-on in the digestive tract without a wholesale invasion of the abdominal cavity. Hollywood has given us Jules Verne-like bits of prescience, such as the 1966 film, Fantastic Voyage. And the SmartPill, made by SmartPill (Buffalo, New York), is a real medical device that continues the trend of merging fact and sci fi-like scenarios in the field of healthcare.
The SmartPill is a system that starts with a capsule measuring 13 mm by 26 mm that encases tiny sensors geared to pick up data on gastrointestinal (GI) pressure, pH, temperature and the total “transit time” of food. The tiny tracker also records the time it spends in each section of the GI tract, providing physicians with a comprehensive survey of the pati-ent’s digestive system.
The pill transmits data to a data receiver, which can be worn in a pocket or on a lanyard around the neck. Within 24 to 48 hours, the pill has completed its trek through the GI tract and the patient returns the data receiver, which the doctor hooks up to a computer via a USB port. One of the benefits of this approach to evaluation of digestive function is that it cuts out the radiological exposure entailed in GI scintigraphy, but the patient also spends less time in a doctor's office because scintigraphy procedures can consume two or more hours to complete.
According to SmartPillCorp, the system’s competitive advantage consists of "its ability to ... capture and transmit in real-time biomedical data from specified segments of the GI tract that can be used to evaluate GI motility.”
That competitive advantage is a reference to the predicate device – SmartPill passing through the FDA maze by means of a 510(k) filing – the so-called Heidelberg pH capsule.
This device, which came into being prior to 1976 and thus did not have to go through the PMA process, is manufactured by Heidelberg Medical (Blairesville, Georgia). However, the name of this device is based on its place of origin, Heidelberg University (Heidelberg, Germany).
Elsewhere in the product pipeline:
• Abbott (Abbott Park, Illinois) reported that it received FDA approval for its Prism hepatitis B surface antigen (HBsAg) and its Prism HBsAg Confirmatory test to screen donated blood for HBsAg. The Prism system was recently approved for use in the U.S. with its first hepatitis B test, Prism HBcore, introduced last October. Additional hepatitis and retrovirus screening tests are currently under FDA review. The Prism instrument consolidates testing into a single system, automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The Prism system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift.
• Abbott Molecular (Des Plaines, Illinois) said a study published in the July edition of Journal of Urology has shown that UroVysion, a DNA-based urine test that detects important genetic changes in bladder cells, has almost twice the sensitivity of conventional urine cytology tests, the current gold standard, as an aid for the initial diagnosis of bladder cancer in patients with hematuria suspected of having bladder cancer. The prospective, blinded study involved 497 eligible patients with an average age of 63 from 23 clinical sites throughout the U.S. and Canada. All patients had confirmed hematuria within three months of enrollment. The results showed that UroVysion detected 69% of bladder tumors, while cytology detected 38%. When low-grade, low-stage tumors were excluded, UroVysion detected 83% of the cases, while cytology detected only 50%. The probability that negative UroVysion results were not associated with bladder cancer in this group was 98.5%.
• The Mosquito, a needle holder device that vibrates to help the cardiovascular surgeon break through blood vessels hardened by plaque, has been developed in a joint effort by Active Ultrasonics (La Chaux de Fonds, Switzerland) and Scottish Health Innovations (SHIL), a technology transfer organization. The device is designed after – and therefore named for – the similar way a mosquito “posits his proboscis into the skin” to find its meal of blood, namely by vibrating to reach past the surface of a victim’s skin, according to Dr. Nigel McLean, business development manager at SHIL. After conducting a web search and with the knowledge of the vascular surgeon, Richard Lerski, MD, affiliated with a hospital in Dundee, Scotland – which McLean said was very well known in vascular surgery – had the idea for the device. McLean said that the key problem for surgeons in this application lies in the fact that it is very difficult to suture blood vessels in any region of the heart where there is calcification, which McLean described as being “a bit like an eggshell ... very hard and brittle.” Because of this, the calcification tends to damage the “very delicate [suture] needles” surgeons used in the heart, and for coronary heart bypass procedures, surgeons attempt to use as small a needle as possible. The Mosquito prototype needle is powered by a small generator. The operator simply pushes a button, and the needle begins to vibrate to crack through the calcification in these highly delicate surgeries.
• AtriCure (West Chester, Ohio) reported that it has received FDA 510(k) clearance for its Isolator Transpolar Pen System for pacing, sensing, stimulating, and recording during the evaluation of cardiac arrhythmias in addition to its currently FDA-cleared use for the ablation of cardiac tissues. The new capabilities of this multifunctional pen allow physicians to identify potential trigger areas on the heart that could cause cardiac arrhythmias. Physicians may ablate these targeted cardiac triggers and directly evaluate the effectiveness of the ablation, all with the same device. The multifunctional system includes specialized electrophysiology accessories that enable physicians to toggle between each function. Separately, the company reported the release of its new Isolator Transpolar open clamp, which leverages the design enhancements of the Isolator minimally invasive system released during the 1Q06. The open clamp features a design that improves the surgeon's access to key anatomical structures, simplifies the ablation procedure and provides superior tactile feedback to the user. The clamp currently has clearance from the FDA for the ablation of soft tissues in general, thoracic and other non-cardiac-related surgical procedures.
• Boston Scientific (Natick, Massachusetts) re-ported the U.S. launch of its iLab Ultrasound Imaging System. Intravascular ultrasound (IVUS) allows physicians to see images inside the heart and inside coronary and peripheral arteries to assist with diagnosis. The first system of its kind, the iLab Ultrasound Imaging System can be directly installed into the cardiac catheterization lab or radiology suite, enabling physicians to quickly and easily incorporate IVUS technology into their procedures every day. The system's tableside controller gives physicians control of the device within the sterile field, and the Dynamic Review feature enhances image interpretation. The system's touch panel provides an intuitive user interface with prompts that correspond to the particular stage of the procedure. The company said the easy-to-upgrade platform allows for future innovation.
• Charles River Laboratories International (Wil-mington, Massachusetts) said that it has received FDA approval of what it said is the first portable endotoxin test system, the Endosafe-PTS. The Endosafe-PTS is used to detect endotoxin contaminants in drugs, medical devices, biological products and other applications. The portable hand-held system can be used for point-of-use testing and provides quantitative results in 15 minutes. The PTS uses disposable cartridges that are pre-loaded with reagents. The simple one-button operation requires minimal technical training and the data can be stored in the PTS, downloaded to a computer and/or printed.
• Drug-eluting coronary stents involve the placement of the drug on the stent, with the drug then gradually being absorbed – currently one of the most common, and profitable applications of a drug/ device combination. Cook (Bloomington, Indiana) has a somewhat different approach in this combination, impregnating the drug within a device - only in this case for preventing the much-feared infection in-volved with the use of central venous catheters. And the company has combined this with a multi-lumen approach to avoid the multiple ways in which the use of catheters may lead to serious catheter-related bloodstream infections (CRBSI). The company announced roll-out of its new five-lumen, drug-impregnated central venous catheter, the next-generation Spectrum, designed to both improve multiple treatment administration and to provide increased protection against hospital-based CRBSI. The device received FDA 510(k) clearance in February. This latest version of the Spectrum incorporates five non-communicating vascular access lumens within a single catheter body to reduce the necessity of performing multiple venipunctures or multiple stopcock configurations using single-lumen catheters, said Tom Saccone, product manager for critical care for Cook.
• Cook Women’s Health (Spencer, Indiana) says that hemorrhage following the birth of a child occurs in 1% to 2% of all deliveries and “represents one of the leading causes of childbirth-related maternal mortality.” But the women’s healthcare company, a division of Cook (Bloomington, Indiana) that launched in May, offers the Cook Bakri Postpartum Balloon, which it calls a potentially lifesaving device to aid in the treatment of postpartum bleeding. “Cook’s Bakri Balloon represents a significant advancement in the treatment of postpartum hemorrhage,” said Christina Ann , global leader of Cook Women’s Health. “The balloon catheter illustrates one example of our vision of revolutionizing gender-based medicine. Cook Women’s Health is committed to improving the quality of life for female patients by offering the highest standard of products that reduce patient recovery times and simplify medical procedures.” Cook received 510(k) clearance for the product about 18 months ago, and it is currently on the market. The Saudi Arabian doctor who developed the product and after whom it is named brought the device to Cook, Ann said, following its successful utilization with many patients. The device was first approved in Europe. The Bakri Postpartum Balloon is an alternative to the current treatments for postpartum hemorrhage, such as packing the uterus with gauze or a surgical solution, such as hysterectomy. Cook says its device not only can stop the bleeding, but do so while preserving fertility.
• Critical Therapeutics (Lexington, Massachusetts) reported the issuance of a U.S. patent for methods of diagnosing and monitoring the severity of several inflammatory conditions by measuring the concentration of a key protein present in a patient’s bloodstream. U.S. patent No. 7,060,504, “Antagonists of HMG1 for Treating Inflammatory Conditions,” involves methods of measuring the concentration of the protein High Mobility Group Box 1 (HMGB1) and comparing that concentration to a representative normal sample. Arthritis, rheumatoid arthritis and lupus are among the inflammatory conditions claimed under the patent. Critical Therapeutics’ HMGB1 patent estate is exclusively licensed to MedImmune (Gaithersburg, Maryland) for the treatment and prevention of diseases. The company also has licensed its HMGB1 diagnostic rights to Beckman Coulter (Fullerton, California), which is developing immuno-assays to detect and manage inflammatory diseases.
• Cyberonics (Houston) reported that it received FDA real-time review approval for its new VNS Therapy Perennia Lead. The Perennia Lead, which is connected to the VNS Therapy System Generator and attached to the left vagus nerve, can be used with the current Model 102 and the future DemipulseT Pulse Generators (Models 103 and 104). The Perennia Lead incorporates a new design constructed from more durable components. It is expected to be available in the U.S. in late 2006.
• Cytori Therapeutics (San Diego) reported top-line preliminary results demonstrating that adipose-derived stem and regenerative cells from its Celution system was safe and improved heart function in a chronic ischemia model, representing a severe form of coronary artery disease. In this blinded, randomized study, seven pigs received their own adipose stem and regenerative cells or a saline injection. Autologous adipose stem and regenerative cells were extracted and concentrated using the Celution system, Cytori's automated cell processing system. The cells were then delivered via the Noga Mapping and delivery system directly into the ischemic sites. Thirty days following treatment, the cell treated group exhibited a 13% absolute improvement in ejection fraction over the control group. Consistent with this functional improvement, heart structure was preserved as evidenced by a 37% thicker ventricular wall in the cell-treated groups vs. the control. The full data and analysis of this study will be presented later this year.
• Dade Behring (Deerfield, Illinois) reported that it has launched an automated Ecstasy test on its Dimension chemistry systems. The new test uses the Syva gold standard EMIT technology, which the company said is the most widely used and extensively validated in the drug testing industry. The Ecstasy test is now available on the Dimension chemistry systems and V-Twin, Viva-E and Viva-Jr drug testing systems. Separately, Dade Behring reported that it has launched the Quadriga BeFree infectious disease testing system to the non-U.S. marketplace. Quadriga is a fully automated, high-throughput system used to screen blood for common infectious diseases such as HIV and hepatitis. It will be used by large, mid- to high-volume blood bank laboratories to screen donated blood prior to it being used for a blood transfusion. Features of the Quadriga BeFree System include automated patient sample handling and verification, automated barcode identification of patient samples, and continuous monitoring of the instrument’s status.
• Disc Dynamics (Eden Prairie, Minnesota) is on a quest for pre-market approval (PMA) of its “novel concept” in its DASCOR Disc Arthroplasty System for the treatment of degenerated lumbar discs, and the FDA just gave the company a green light for the first step on that regulatory path. The agency gave the company approval to initiate what will be a 20-patient pilot trial, and CEO Steven Healy said he expects enrollment in the study to take until the end of 2006, with patients then to be followed for one year. The technology is a catheter-based, minimally invasive nucleus replacement technology, otherwise known as a partial disc replacement system.
Although the company received CE mark approval for commercial sale of the technology in July 2005, Healy said, “We’ve got an approval in Europe, but we’ve just continued to do a post-market approval study, and in 2007 we will begin commercialization efforts.” He said the distinguishing aspect of the DASCOR Disc Arthroplasty System is that the procedure can be carried out percutaneously – just as in some interventional cardiology strategies – thro-ugh about a half-centimeter incision, thus avoiding the open procedure required in fusion surgeries.
“The concept for this system is to go in through a very small hole and to be able to deliver a very large implant,” Healy said. Using a “series of micro-instruments" developed by Disc Dynamics, "the surgeon goes in and removes the diseased nucleus material,” he said. The company also uses imaging during the surgical procedure to make sure that “the appropriate amount of material is removed” from the nucleus area. The device itself involves a balloon on the end of a catheter, with the balloon then filled with “a liquid polymer under pressure" to ensure that the entire area where the diseased nucleus was located is filled – all toward the goal of returning a patient to “normal disc height.”
“Our goal is either to maintain or increase disc height,” Healy said. “And then this material that goes in as a liquid solidifies in just a few minutes.” Healy said the product – which was originally developed by Advanced Bio Surfaces (Minnetonka, Minnesota) and then spun off in 2000 as Disc Dynamics – is a totally “novel concept” and that there is nothing similar to it on the market. It is, he said, “an incredibly minimally invasive procedure.”
• Dynatronics (Salt Lake City) said it has begun shipping its Dynatron X3 light therapy unit. The X3 features advanced light therapy technology, commonly used for treating muscle and joint pain as well as arthritis pain and stiffness. The company said the stand-alone unit is capable of delivering three independent treatments and uses an interactive touch screen display that helps make treatment setups fast and easy. The device has the ability to drive two Dynatron Light Pads and a light probe simultaneously, making it the company's most powerful light therapy device available on the market. The company also plans to introduce the DX2 combination traction/ light therapy device -– the first combination device of its kind – during the present quarter.
• Elekta (Stockholm, Sweden) reported FDA 510(k) pre-market clearance for Leksell GammaPlan PFX, the treatment planning system developed for Leksell Gamma Knife Perfexion. Elekta is expanding its Leksell Gamma Knife product line with a new stereotactic radiosurgery system that provides a radiosurgical platform for further refinement and expansion of procedures in the brain, cervical spine and head and neck regions. Leksell Gamma Knife Perfexion is pending 510(k) clearance from the FDA.
• FlowCardia (Sunnyvale, California), a company focused on coronary and peripheral catheter-based systems for chronic total occlusion (CTO) recanalization, said it has completed enrollment in the FlowCardia’s Approach to Chronic Total Occlusion Recanalization (FACTOR) pivotal study. The 19-hospital, 125-patient study was designed to assess the safety and efficacy of the company’s Crosser catheter in chronically occluded coronary arteries. Wick Goodspeed, president and CEO, said, “We hope to file a request for Crosser 510(k) clearance in September [and] anticipate clearance from FDA before the end of this year.” FlowCardia also said that it received approval from the FDA to start the pivotal phase of the Peripheral Approach To Recanalization In Occluded Totals (PATRIOT) study after completion of the feasibility phase in June. The 10-hospital, 85-patient U.S. pivotal study is designed to determine the safety and efficacy of the Crosser catheter in totally occluded peripheral arteries. The Crosser System is a monorail catheter delivered over standard guide wires to the site of a CTO. It uses high-frequency, mechanical vibration and is designed to facilitate crossing of CTOs, allowing for subsequent debulking, balloon angioplasty and stent placement.
• GE Healthcare (Waukesha, Wisconsin) reported development of the Aisys Carestation anesthesia delivery system, working with GE Plastics, the first GE anesthesia solution to integrate electronic gas and agent control as well as delivery with advanced ventilation, vital signs monitoring and an advanced breathing system. The GE Aisys perioperative care station integrates devices, therapies and information systems at the point of need. The Aisys Carestation integrates with hospital information systems and GE Centricity anesthesia systems, which collect and document anesthesia delivery and physiological data. The all-in-one Aisys Carestation was designed to provide a reduced footprint. To maximize mobility and reduce clutter, the device offers features such as CableCare, a cable management solution, and INview Patient Displays mounted on a moveable arm with 360 degrees of rotation.
• HydroCision (Billerica, Massachusetts) reported the initial release of its SpineJet XL MIS Fusion Preparation System into the spine segment of the orthopedic market in the U.S. The SpineJet XL MIS Fusion Preparation System provides spine surgeons with a fluidjet-powered medical device that simultaneously cuts, ablates and removes hard and soft tissue – such as disc nucleus and endplate cartilage -- quickly, safely and effectively, in preparation for graft implantation during minimally invasive lumbar interbody fusion procedures. The system is designed to work in conjunction with all currently available minimally invasive access systems.
• IBM (San Jose, California) reported a major step in the drive toward a national electronic medical records system by contributing software technology that supports the exchange of healthcare information to the open source community. The software, contributed to the Eclipse Foundation’s Open Healthcare Framework (OHF) project, provides a mechanism to connect isolated “islands” of information that today reside throughout the healthcare system to any Health Information Exchange (HIE). Software developers also will be able to build applications that can aggregate and sift through this information to improve healthcare delivery and research while protecting individual privacy. OHF, one of the leading efforts to deliver an open-source, standards-based platform for healthcare software, has close ties to leading healthcare standards organizations. Any independent software vendor will be able to use the tools in OHF to connect their applications to any standards-based infrastructure, including IBM’s HIE.
• Medrad (Indianola, Pennsylvania) and GE Healthcare reported the availability of the first endorectal coil for 3.0T magnetic resonance (MR) prostate imaging. The Medrad 3.0T Prostate eCoil is available for GE Signa HDx 3.0T MR scanners through sales representatives from Medrad and GE Healthcare. The 3.0T Prostate eCoil is designed to produce diagnostic images of the prostate that may enable early diagnosis and staging of prostate cancer in a way that helps physicians localize treatment to only the affected part of the gland. The eCoil balloon conforms to the size and shape of the prostate for consistent contact between the gland and the signal-amplifying elements of the coil, thus producing a small field-of-view and high spatial resolution, sensitivity, and specificity that yield clearer pictures of the prostate, according to the company. Medrad is focused on developing medical devices and services that enhance imaging procedures of the human body, including vascular injection systems, MR surface coils and patient care products, and equipment services.
• MicroIslet (San Diego), which is engaged in the development of technologies in transplantation therapy for people with insulin-dependent diabetes, said that primate subjects in ongoing studies have continued to exhibit improved glycemic control over a six-month period by means of the company’s microencapsulated porcine islet transplantation treatment approach. MicroIslet said the breakthrough was achieved without the need for chronic immunosuppressive therapy to prevent rejection of the transplanted insulin-producing islets. “We believe that with this positive data, we are setting the cornerstone for a new and vastly improved treatment for diabetes,” said James Gavin III, MD, PhD, president and CEO. He said, “We have achieved long-term survival of transplanted insulin-producing islets in our primate subjects [and] these islets have substantially reduced the need for injected insulin to control blood glucose levels and prevent the progressive damage to the heart, kidneys and other vital organs that make diabetes so devastating.” The company plans to submit abstracts documenting its findings to major transplantation symposia this fall and at the American Society of Cell Biology annual meeting in San Diego Dec. 9-13.
• North American Scientific (Chatsworth, California) reported that its Nomos radiation oncology division has received 510(k) clearance from the FDA to market nomosSTAT, its new serial tomotherapy automated treatment solution. nomosSTAT integrates the company’s core serial tomotherapy delivery products, nomosSTAT MLC and AutoCrane, with a single user interface. The new interface, with network connection to the Corvus IMRT inverse planning system, streamlines the delivery process. As the only after-market, add-on serial tomotherapy delivery package offered as an upgrade to an existing linear accelerator, the company said it provides an affordable solution for facilities wanting to implement IMRT as part of their cancer treatment arsenal. nomosSTAT’s serial tomotherapy delivery shapes and modulates the radiation beam while the gantry is rotating, providing up to 40 individual intensity-modulated beams per every 5 degrees of rotation. These beams can be fired from virtually any radial angle around the patient and can vary in intensity in 10% steps.
• Implanon, a single-rod contraceptive implant from Organon (Roseland, New Jersey), has been ap-proved by the FDA. Organon said it is the first and only single-rod implantable contraceptive that is effective for up to three years. Implanon was first approved for use outside the U.S. and has been used and marketed – with about 2.5 million implants thus far – in 30 countries since 1998. “Implanon, based on the clinical trial data and our review of post-marketing data from other countries outside the U.S., is a highly effective contraceptive that importantly does not depend on patient compliance,” said Scott Monroe, MD, acting director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, during a teleconference. Implanon continually releases a “low, steady dose” of a progestin, called etonogestrel, for a period of up to three years via Organon’s technology, the company said. Implanon is about the size of a matchstick and is made of a “soft medical polymer,” Organon said, inserted into the upper inner portion of the arm. A minor surgical procedure that can be accomplished in a physician’s office with a local anesthetic is necessary both to implant the device and to remove it.
• Ortec International (New York) reported its key goals and objectives for the balance of 2006. Within the next month, Ortec plans to submit a humanitarian device exemption supplement to the FDA to obtain marketing approval for use of cryopreserved OrCel, a cellular product for accelerated skin regeneration for chronic and acute wound care, in the treatment of recessive dystrophic epidermolysis bullosa. Within the next six weeks, Ortec expects to complete the confirmatory trial designed to confirm the superiority of cryopreserved OrCel in the treatment of difficult-to-heal venous leg ulcers in comparison to the standard of care therapy. During the third quarter, Ortec expects to move forward with integrating the clinical data from the current trial with the efficacy data from the 12-week pivotal trial previously submitted to the FDA as part of the company's PMA. Ortec expects to submit a supplemental PMA to the FDA in 4Q06. For its Haptides technology, a cell attachment peptide for tissue repair and regeneration, Ortec currently projects an 18-month milestone-driven development plan to allow the product to be in a FDA clinical trial. Other key objectives in 2006 for the Haptides technology include evaluating other product opportunities for Haptized collagen in the areas of chronic wound healing, periodontal regeneration and as a matrix for Mesenchymal type adult stem cell differentiation and delivery. Ortec’s milestone-driven development plan for its Fibrin Microbeads – cross-linked, heat-treated fibrin beads that can be used to isolate matrix-dependent cells – currently provides for the ability to initiate an FDA clinical trial in bone regeneration within about 18 months. A pre-clinical trial evaluating Fibrin Microbeads for bone regeneration has recently been initiated.
• Possis Medical (Minneapolis) reported market release of the AngioJet SpiroflexVG Rheolytic Thrombectomy catheter. The new Spiroflex VG Cath-eter provides over twice the clot removing power compared to the company’s 4 Fr XMI and Spiroflex catheters and it is the first AngioJet catheter of its size to be offered in a rapid-exchange platform. Utilizing its Spiroflex shaft technology, the Spiroflex VG cath-eter benefits from several design improvements made to the most recent generation of Possis Medical products. The new catheter offers improved trackability inside the vessel and includes tip and hub improvements found on the recently introduced Spiroflex catheter.
• Resverlogix (Calgary, Alberta), developer of compounds for use with medical devices, has found a partner for its early-stage pharma technology, ReVas, for a large cardiovascular application. The company will work with Medtronic (Minneapolis), to create a drug-eluting stent (DES), as the med-tech titan seeks to be the third to enter the DES derby. The companies said they would begin the work by completing development of the technology. If they agree to move forward with additional product development, Med-tronic would make an initial cash payment to RVX, a subsidiary of Resverlogix, followed by milestones and royalties. All told, RVX could receive up to C$340 million ($291 million). “It’s the largest pre-clinical deal ever done in Canada,” Don McCaffrey, co-founder and president/CEO of Resverlogix, said. Medtronic’s zotarolimus DES, Endeavor, is finishing up clinical development for a U.S. application. The stents all use “a version of either rapamycin or paclitaxel,” McCaffrey said. Since both of those are oncology drugs, “they’re a little harsh on the endothelial lining in the artery.” He added that while those drugs might be effective in preventing restenosis, “at 90 days out, you’re seeing some thrombotic issues, some ruptures and, in some cases, death.” Resverlogix’s ReVas program is aimed at designing a drug that “actually encourages the healing of the endothelial lining,” in addition to reducing the smooth-muscle cell proliferation that leads to restenosis, McCaffrey said. “So, it’s kind of a new-generation drug for the stent market.”
• Smith & Nephew said its Orthopaedic Trauma & Clinical Therapies (Memphis, Tennessee) division reported the launch of the Trigen Intertan Inter-trochanteric Antegrade Nail for the treatment of femoral fractures. The Trigen nail features a two-screw configuration that secures the nail in place after surgery, acting together to provide greater stability for the bone and reduced healing time. Previous generations of intramedullary nails for femoral fractures used a single screw that sometimes contributed to a loosening of the device. With more than 200 clinical cases already completed, the company said improved results include earlier weight bearing by patients and shorter healing times. Smith & Nephew also said the Orthopaedic Trauma & Clinical Therapies division received FDA approval for its Exogen 4000+ Bone Healing System, a low-intensity pulsed ultrasound device externally applied 20 minutes a day over the site of a broken bone. According to the company, it is the only bone stimulator using ultrasound technology approved to treat fractures that that have failed to heal and approved to heal specific fresh fractures faster. The company said the Exogen 4000+ is clinically proven to speed up the healing of certain new fractures by 38% and effectively heal 86% of hard-to-heal bone fractures. The system will launch in domestic and international markets this fall, and will replace the Exogen 2000+. The more compact Exogen 4000+ features a larger screen for easier visibility, a simple one-button operation, and a louder audio beep to signal operation.
• Spectranetics (Colorado Springs, Colorado) said that the first patient was enrolled in the CELLO trial, an FDA-approved trial that will enroll 85 patients at up to 15 sites. The trial will provide clinical data on the reduction of the arterial blockage in above the knee arteries following use of the Spectranetics' Turbo-Booster product. The patient enrolled in the trial is a 72-year-old female suffering from severe, lifestyle-limiting claudication. The artery treated was 6 mm in diameter and was 85% stenosed prior to the procedure. Following multiple passes with the Turbo-Booster device, the stenosis was reduced to 25%. The results of the procedure were sufficient for a stand-alone case result that did not require further adjunctive treatment with other devices.
• Stryker Orthopaedics (Mahwah, New Jersey) said laboratory testing on wear simulators shows a 96% wear reduction over the leading competitive premium bearing technology with the combination of Stryker’s X3, a highly crosslinked polyethylene, and the Triathlon Knee System, a design noted for its improved range of motion and fit. By reducing wear, Stryker expects to improve the longevity of its implants, which has emerged as one of patients’ most fundamental concerns about knee replacement surgery, according to a new survey conducted by Harris Interactive. Stryker’s X3 advanced bearing technology uses a patented annealing process in which the temperature is kept below the melt point following irradiation, the material properties of the polyethylene are preserved. X3 is the first polyethylene that is sequentially irradiated annealed, which increases the wear resistance of the material while maintaining its strength. The Triathlon Knee System is designed to provide patients more natural motion, and the potential for greater implant longevity. It is available in a range of sizes to more closely fit the anatomies of both men and women.
• Toshiba America Medical Systems (Tustin, California) reported the availability of a new upgrade for the Nemio ultrasound system. The Nemio XG provides the image quality needed to render a fast, accurate diagnosis – limiting the number of patients who are referred for more serious procedures, testing and follow-up. The next-generation Nemio XG features enhancements from Toshiba’s flagship Xario ultrasound system, designed to expand diagnostic capabilities and improve clinical insight. The Nemio XG technology features Advanced Dynamic Flow, a more sensitive color Doppler and more detailed images for faster, more accurate diagnosis; QuickScan, optimized 2-D images with the touch of a button; and ApliPure, faster image acquisition and greater clarity.
• W. L. Gore & Associates (Flagstaff, Arizona) said site initiation and enrollment has begun in the Embolic Protection with flow Reversal (EMPiRE) clinical study. This investigational study is designed to demonstrate the safety and efficacy of the Gore Neuro Protection System when used for embolic protection during carotid artery stenting procedures. The first patients were enrolled and successfully treated for narrowing of the carotid arteries at the University of Buffalo (Buffalo, New York). The patients all recovered from their procedure without incident, and have been discharged from the hospital. The system operates on the principle of reversing the flow of blood at the treatment site. Unlike available embolic protection devices, flow reversal enables physicians to perform carotid interventions knowing that liberated emboli will be safely directed away from the brain. Flow reversal is achieved at the treatment site by selectively occluding common carotid and external carotid artery blood flow.
• Wright Medical Group (Arlington, Tennessee), a global orthopedic medical device company, reported launch of its Profemur Renaissance Total Hip System. The system features a stem designed to provide enhanced proximal fixation and immediate rotational stability within the femur. As part of Wright’s Profemur family of implants, the Renaissance stem also incorporates modular neck technology, well-suited for a less invasive surgical approach. The Profemur Renaissance hip stem is designed to achieve enhanced fixation through a combination of features at both the proximal and distal ends of the implant. The company said this improved dual fixation reduces micromotion of the implant, thereby facilitating osseointegration within the femur.
• Zimmer Dental (Carlsbad, California), a pro-vider of dental oral rehabilitation products and a subsidiary of Zimmer Holdings (Warsaw, Indiana), reported the availability of the new Zimmer Surgical Motor System for surgical specialists who perform implantology and maxillofacial surgeries. The Zimmer Surgical Motor System offers programs with 20:1 and 1:1 reduction ratio to facilitate implant placement and also wisdom teeth and bone shaping/grafting procedures.