Independence Technology (Warren, New Jersey), a Johnson & Johnson (J&J; New Brunswick, New Jersey) subsidiary, has received FDA approval for what could very well be the Mercedes of wheelchairs, the iBOT 3000 Mobility System though its developers stressed that it should be called a "mobility device," not a wheelchair. The iBOT is a gyro-balanced personal mobility system that is designed to provide new levels of freedom and accessibility for those with disabilities.
Unanimously endorsed by the FDA's Orthopedic and Rehabilitation Advisory Panel last November, the iBOT was termed a "way cool" device by one of the panel members. It uses a combination of electronics, sensors and software components that mimic the way non-disabled people maintain their balance to continuously and automatically adjust wheel position and seat orientation to stabilize the user. "It can help improve the quality of life of many people who use wheelchairs by enabling them to manage stairs, reach high shelves and hold eye-level conversations," said FDA Commissioner Dr. Mark McClellan.
The device is the invention of Dean Kamen, founder of DEKA Research & Development Corp. (Manchester, New Hampshire), with whom J&J partnered to develop the iBOT. Kamen also is the inventor of the Segway scooter. Jean-Luc Butel, president of Independence Technology, describes the iBOT as the most thoroughly tested, studied and sophisticated device ever manufactured for the disability community. "It is our hope that the arrival of the iBOT Mobility System will create greater awareness of the importance of providing equal accessibility to every person with a disability," Butel said in a statement.
He added, "It is estimated that approximately 2 million Americans use a wheelchair or scooter type of mobility aid. For people with mobility-related disabilities, the iBOT Mobility System represents breakthrough technology not available in any other product. In essence, [the system] empowers users to go where they want to go, helping satisfy the natural human desire for mobility and freedom."
The iBOT has five functioning features. The Balance Function elevates the user to move around at eye level and to reach high places independently. In this function, the front wheels rotate on top of the back wheels while the user remains seated at a higher height. The Stair Function enables the user to safely climb up and down stairs, with or without assistance, often gaining access to previously inaccessible places. The 4-Wheel Function enables the user to climb curbs as high as four inches and to travel over grass and gravel, through sand and across other forms of uneven terrain. The Remote Function allows the user or an assistant to drive the device into a Sport Utility Vehicle or van for easy transport. And the Standard Function enables the user to operate the device in the same manner as if in a traditional powered chair.
The system travels at six miles an hour in Standard Function, and is powered by rechargeable batteries. Depending upon usage, it can run all day on a single charge. Multiple computer backup systems have been designed to help ensure user safety in all functions. The joystick-operated steering system is proportional and directional, comparable to current joystick power wheelchairs on the market today. The system's features and functions will be customized to the individual requirements of the user.
Elsewhere in the product pipeline:
Abbott Laboratories (Abbott Park, Illinois) said its cardiovascular device franchise, Abbott Vascular Devices, reported the launch of an enhanced version of the Perclose A-T suture-mediated closure system designed to further improve ease of use and reduce the vessel closure procedure time. A new suture trimmer facilitates both knot advancement and suture trimming, eliminating a potentially time-consuming step in the vessel closure procedure for many operators. Human factors engineering was incorporated into the design of the trimmer to create a device that is more comfortable and intuitive to use. Numbers that correspond to the procedural deployment steps have been added to the Perclose A-T, making the device easier to learn and use.
Alexion Pharmaceuticals (Cheshire, Connecticut) reported preliminary results of its Phase III study in a large, multinational trial consisting of more than 3,000 patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass, a study referred to as Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery, or PRIMO-CABG. The primary endpoint in the trial was a composite of the incidence of death or myocardial infarction, measured at 30 days post-procedure, in patients undergoing CABG without concomitant valve surgery. Although there was reduction in the primary endpoint, it was not achieved with statistical significance. Key pre-specified secondary endpoints consisting of the same composite in the total study population, which included all patients undergoing CABG with or without concomitant valve surgery, were achieved. Several other pre-specified secondary endpoints also were met, Alexion said.
Aurora Imaging Technology (North Andover, Massachusetts) reported FDA 510(k) market clearance for its 1.5 Tesla Dedicated Breast MRI System, the only commercially available MRI system designed specifically for breast imaging. The increase in the system's performance will result in improved image resolution and is a precursor to the integration of Aurora's proprietary fat-suppressed, high-resolution, high-contrast imaging technique. The Aurora System is designed to be located within a breast care center, where it is readily available to specialized physicians and their patients.
Bio-Rad Laboratories (Hercules, California) has received a license from the FDA for its HIV-1/HIV-2 PLUS O EIA test kit used for diagnostic testing and the screening of blood and blood products. The test simultaneously detects both HIV-1 (groups M and O) and HIV-2 antibodies. This test is significantly more sensitive than the currently licensed HIV-1/HIV-2 Peptide EIA test kit, the company said. The new test, which incorporates a specific sequence designed to detect the Group O variant of HIV-1, has detected 100% of the HIV-1 Group M, HIV-1 Group O and HIV-2 samples tested. Variants of HIV-1 may elude detection by tests that lack a Group O-derived specific sequence. Bio-Rad has incorporated a synthetic polypeptide mimicking an artificial HIV-1 Group O-specific epitope into the HIV-1/HIV-2 PLUS O EIA test kit, which uses a third generation assay format. The new kit detected all 77 Group O serum samples obtained from Africa, France and the U.S., as well as 100% of the HIV-1 Group M and HIV-2 serum samples tested.
Biosite (San Diego, California) reported the start of the RABBIT (Rapid Assessment of Bedside BNP in Treatment of congestive heart failure) clinical trial, which is designed to evaluate measurements of b-type natriuretic peptide (BNP) in outpatients with heart failure. Enrollment is expected to last six months, with a follow-up period of 12 months. Biosite said it expects to evaluate about 720 patients enrolled from at least 20 U.S. outpatient clinics as part of the RABBIT trial. The trial is a prospective, cluster-randomized study designed to show the value of assessing disease severity of outpatients living with heart failure, a progressive disease. The primary endpoint for the study is a combination of morbidity, mortality and perceived quality of life.
Cardiac Science (Irvine, California) reported the launch of two new portable automatic external defibrillators (AEDs) the Powerheart AED G3 and the FirstSave AED G3. The new AEDs, which share the same technology platform, differ in features, price and warranty and will address the varying needs of customers in the corporate, municipal, home and medical markets. The G3 line offers customer-friendly features such as one-button operation and RescueReady technology to ensure reliability. They also incorporate the company's RHYTHMx analysis software and STAR biphasic shocking engine. The new products are currently in production, with delivery beginning to international customers and distributors last month. Shipments in the U.S. will begin upon receipt of marketing clearance by the FDA.
Conceptus (San Carlos, California) reported that the July issue of Obstetrics & Gynecology features data from the pivotal trial of Essure, a nonincisional, permanent birth control device. The study findings show that 92% of employed women who underwent the procedure returned to work in one day or less. Among the study findings, nearly 60% of Essure patients were back to their regular physical activities within one day, and within two days nearly 75% had resumed regular activities.
Digirad (San Diego, California) reported the release of what it said is the first upgradable nuclear gamma camera available on the market. Cardius -1 is a solid-state nuclear gamma camera with a single detector that is dedicated exclusively to cardiac imaging. The system is upgradable to a dual-head system to efficiently accommodate higher patient volumes with faster throughput. The system is comprised of a solid-state nuclear gamma camera, a portable acquisition/processing station and an upright imaging chair. The imager is also equipped with the new Solidium detector, Digirad's third-generation solid-state technology. The upright imaging convention increases patient comfort and reduces the incidence of claustrophobia, the company said.
Eastman Kodak (Rochester, New York) launched several new products that it said offer greater efficiency and productivity in the capture, management and output of digital medical images at the American Healthcare Radiology Administrators conference in Anaheim, California. The Kodak DirectView CR 950 System is a departmental solution that can support several exam rooms. The new Kodak DirectView PACS System 5 offers reliable digital image management and distribution. A new Kodak flagship laser printer, the Kodak DryView 8900 Laser Imaging System, also is available. This imager delivers high-quality images, while maintaining throughput of up to 200 films an hour. Kodak also introduced several new services that integrate its picture archiving and communications systems (PACS) with other healthcare information systems.
HydroCision (Andover, Massachusetts) reported the initial release of its SpineJet Hydrosurgery System in the U.S. The SpineJet Resector provides spine surgeons with a powered device to quickly, safely and selectively remove soft tissue in preparation for disc graft implantation during open and minimally invasive spinal fusion procedures. The fluidjet-based surgical instrument is powered by HydroCision's HydroDrive technology, which enables the surgeon to simultaneously hold, cut and remove tissue precisely and effectively. Removal of the disc is achieved in a single step with a single instrument while preserving the surrounding tissue.
Medtronic (Minneapolis, Minnesota) reported full U.S. availability of the company's NC Stormer high pressure, non-compliant balloon dilatation catheter. The balloon is now available on both Medtronic's Zipper Multi-Exchange (MX) and Over-the-Wire delivery platforms. The company recently launched the Stormer on the Zipper MX platform, which offers significant benefits over competitive delivery technologies because it facilitates fast and easy exchange of guidewires and catheters during a coronary angioplasty or stenting procedure, the company said. Medtronic also said a study published in a recent issue of Journal of the American College of Cardiology showed that the use of a small, implantable monitor in patients who experience episodes of unexplained fainting (syncope) can lead to a diagnosis at a lower cost than conventional testing strategies. To evaluate the benefits of the implantable monitor, investigators at the University of Western Ontario (Windsor, Ontario) conducted a randomized clinical trial in 60 patients who were undergoing cardiac testing for syncope. Of the patients who received Medtronic's Reveal Plus monitor, 47% were successfully diagnosed, while only 20% who received conventional testing were accurately diagnosed. Conventional testing included two to four weeks of monitoring with an external loop recorder followed by tilt table and invasive electrophysiologic testing. The study authors concluded that the Reveal Insertable Loop Recorder should be considered as an early-stage diagnostic tool for people without major structural heart disease who experience unexplained fainting spells.
Micro Therapeutics (Irvine, California) received FDA clearance to market the Sapphire line of detachable, embolic coils. Embolic coils are used for the minimally invasive, catheter-based treatment of cerebral aneurysms. In the U.S., the Sapphire coil line will complement existing MTI products, including the Mirage guide wires, the HyperGlide and HyperForm balloon catheters, and the multiple microcatheters developed and manufactured by the company.
Quest Diagnostics (Teterboro, New Jersey) said that it has begun to offer a test to enable physicians to detect a new risk factor for cardiovascular disease by measuring levels of the enzyme Lp-PLA2 (lipoprotein-associated phospholipase A2). Elevated levels of Lp-PLA2 indicate that a patient is at an increased risk of suffering a cardiovascular event, such as a heart attack. In some cases, this test identifies patients who do not have other apparent risk factors. The Lp-PLA2 test is designed to be used in conjunction with clinical data and other diagnostic markers. The company performs the test under an agreement with diaDexus (South San Francisco, California).
Omnicell (Palo Alto, California) reported a major upgrade of SafetyMed, its bedside nursing workflow automation solution that it said will significantly improve medication safety in hospitals throughout the U.S. Nurses use the solution to scan bar code information from the patient's wristband, from the medication packaging and from their own identification badges. SafetyMed is accessed through a thin client, portable wireless device with a Citrix server for enhanced security and patient confidentiality.
Ortec International (New York) reported the results of a multi-centered controlled pilot study assessing the effectiveness of its product, OrCel, in treating diabetic foot ulcers. The results of the trial, as described in an article in the July issue of Wounds, demonstrated that in hard-to-heal diabetic foot ulcers that were less than or equal to 6 cm, 47% of the patients treated with OrCel were completely healed compared with 23% of the control group. The study also showed that the mean rate of reepithelization (wound closure) was significantly higher in the OrCel treated groups. The authors concluded that the OrCel treatment described in the study "augments the wound healing process in diabetes, increasing the speed of wound closure and the success rate for complete healing." After submitting its premarket approval application (PMA) to the FDA to market OrCel for the treatment of venous ulcers, Ortec expects to begin a pivotal trail using the product in diabetic foot ulcers. Ortec said it expects to file the PMA by the end of the year.
Orthovita (Malvern, Pennsylvania) has begun patient enrollment in its second U.S. pilot clinical study to evaluate the use of CORTOSS Synthetic Cortical Bone Void Filler in the treatment of vertebral compression fractures. The new pilot study will be conducted at four sites and will enroll a total of 20 patients. In the study, Orthovita's CORTOSS synthetic biomaterial will be injected percutaneously through the skin into the fractured vertebra using the vertebral augmentation procedure known as kyphoplasty.
Proxima Therapeutics (Alpharetta, Georgia) reported publication of data from a multi-center study of its GliaSite Radiation Therapy System (RTS) in the August issue of the Journal of Neurosurgery. The GliaSite RTS internally administers radiation following surgery to remove the tumor at the site where recurrence is most likely. Results showed that the GliaSite RTS performs safely and delivers a therapeutic dose of radiation to tissue at highest risk for tumor recurrence. The study evaluated the safety and performance of the GliaSite RTS in patients with recurrent malignant brain tumors, following surgical removal of these tumors. The study was sponsored by the National Cancer Institute's (Bethesda, Maryland) Clinical Trials Evaluation Program.
Smith & Nephew Orthopaedic Division (Memphis, Tennessee), a subsidiary of Smith & Nephew plc, reported the advancement of "uni-knee" replacement surgery with the combination of two of its technologies: the Accuris instrumentation system and a new knee implant made from the company's Oxinium brand oxidized zirconium metal. Oxidized zirconium, the material from which Oxinium implants are made, has been shown in tests to be 160 times smoother and 4,900 times more abrasion-resistant than cobalt chrome, the metal used in traditional uni-knee replacements. The company said the Accuris instrument system is orthopedic medicine's only uni-knee instrument set to use patient-specific range of motion for guidance, a solution that may prevent premature implant failure due to poor implant placement. With the motorized femoral reamer in place beneath the affected condyle, the patient's leg is slowly extended, producing what the company said is an ideal femoral cut and implant position based on the anatomy of that specific patient.
Sorenson Medical (Salt Lake City, Utah) reported the availability of its new ambIT pain management infusion pumps. Small, lightweight and portable, the ambIT PCA (Patient Controlled Analgesia) and ambIT LPM (Local Pain Management) pumps deliver a controlled infusion of local anesthetic to the intra-operative site and nerve block regions. The ambIT PCA also can be used as a traditional PCA pump to deliver IV narcotics. The ambIT pumps have multiple flow rates and infusion durations along with many other customized features.
STAAR Surgical (Monrovia, California) said the July/August issue of the Journal of Refractive Surgery published the findings of a study comparing the retinal image quality and postoperative aberrations of patients of laser in situ keratomileusis (LASIK) with patients that were implanted with STAAR's ICL. The article concluded that eyes that were treated with the LASIK procedure had, on average, up to three times more aberrations than eyes that were implanted with the ICL. The prevalence of these aberrations, which cause images to appear hazy or blurred and slightly out of focus, tends to be higher in procedures involving the cornea, such as LASIK, as opposed to those that preserve the cornea, such as ICL surgery. The STAAR ICL is under FDA review for marketing in the U.S. for the correction of myopia, or near-sightedness, in the range of -3.0D to -20.0D.
Thoratec (Pleasanton, California) has received European marketing approval for the Thoratec IVAD, an implantable heart pump that helps support one or both chambers of the heart. The device is a smaller, implantable version of the company's ventricular assist device or VAD, which typically rests outside the patient's chest with tubes connected to the heart. Both devices support heart function and blood flow in late-stage heart failure patients who are awaiting heart transplantation or recovering from open-heart surgery. Thoratec said that at less than a pound, the IVAD is the smallest commercially available implantable VAD device. The approval follows a clinical trial involving 17 patients in Europe. A similar trial is currently under way in the U.S., and the company hopes to seek U.S. regulatory approval later this year.
Vascular Solutions (Minneapolis, Minnesota) said that it has received CE mark approval for its Pronto extraction catheter. The Pronto consists of an extraction catheter with a proprietary atraumatic distal tip and large extraction lumen that can be delivered into arteries to remove soft thrombus. A user-friendly syringe extraction system allows for a single operator deployment with total preparation and deployment time of less than two minutes.
Vision-Sciences (Natick, Massachusetts) said that it has received clearance from the FDA to market its new Trans-Nasal Esophagoscope with EndoSheath System. Trans-Nasal Esophagoscopy enables the physician to evaluate the esophagus and stomach of patients with gastroesophageal reflux disease in an office setting with a flexible endoscope and does not require the use of X-rays or general anesthesia. The use of a single-use sheath allows for the safe and efficient passage of a flexible endoscope without requiring lengthy cleaning procedures and the use of chemical disinfectants that may cause irritation.
VNUS Medical Technologies (San Jose, California) reported the results of a multi-center randomized trial comparing recovery rates and quality of life between patients treated with conventional varicose vein stripping surgery and radiofrequency vein ablation, the company's Closure procedure. In the trial, patients receiving the Closure procedure consistently experienced less pain and returned to normal activities more than three times faster than patients whose veins were surgically stripped. Data from the 85-patient prospective randomized study appears in the August issue of the Journal of Vascular Surgery.
World Heart (Ottawa, Ontario) said it has provided the FDA with an amended submission in response to the agency's request for additional data and statistical analyses as part of its expedited review of the company's destination therapy premarket approval supplement for the Novacor LVAS (left ventricular assist system). WorldHeart said it expects a decision from the FDA this year as to expanding the Novacor LVAS patient population to include a portion of end-stage heart-failure patients who, at the time of implantation of the device, are not candidates for transplantation.
Zimmer (Warsaw, Indiana) released the results of a 300-case study of its Minimally Invasive Solutions (MIS) 2-Incision hip replacement and said that more than 200 orthopedic surgeons worldwide offer the minimally invasive procedure. New instrumentation and a muscle-sparing surgical technique are enabling surgeons to place the same clinically proven hip implant used in traditional surgery through two incisions of 1-1/2" to 2" each, rather than the standard 10" to 12" incision. Of more than 300 patients at three medical centers treated with the Zimmer procedure, more than 80% were discharged to their homes within 24 hours or less of their surgery.