Biomet (Warsaw, Indiana) said the FDA has granted marketing clearance for its second-generation highly crosslinked polyethylene, ArComXL, an engineered polymer that the company said has demonstrated a 47% to 64% volumetric wear rate reduction over the first-generation ArCom Polyethylene.
"ArComXL is a new bearing material based on the already proven ArCom product that delivers sup-erior wear characteristics without the adverse consequences of reduced mechanical integrity or potential for oxidation that defines the currently marketed generation of highly crosslinked polyethylenes," President and CEO Dane Miller, PhD, said in a statement. "ArComXL sets a new performance standard in terms of mechanical strength, oxidation resistance and wear resistance in polyethylene, which is attributable to our patented processing technique."
Biomet said it is the only orthopedic company to offer a second-generation highly crosslinked polyethylene material.
Derek Edgar, a Biomet product manager who works on the ArCom line, said the first-generation product was developed in the early 1990s. "We were and still are the only company to manufacture our polyethylene in-house through what we call isostatic compression molding," he told The BBI Newsletter.
Extensive in vitro testing was conducted internally and in conjunction with independent laboratories to measure metrics such as resistance to abrasive wear, subluxation wear, oxidation, fatigue and crack propagation. The results of comparison testing to ArCom were universally positive and have validated the utility of Biomet's patented process, the company said.
Elsewhere in the product pipeline:
Biosite (San Diego) said the FDA has accepted the company's Triage Stroke Panel premarket approval application (PMA) for further review. The panel is intended for use as an aid in the assessment and diagnosis of cerebral ischemia, or stroke. The Triage Stroke Panel consists of multiple biomarkers and uses a proprietary algorithm to calculate a single MultiMarker Index result. Biosite submitted its PMA for the Triage Stroke Panel in December. Existing methods to diagnose stroke and confirm symptoms utilize radiographic imaging, such as computed tomography, which are subject to interpretation and often unable to detect the most common form of stroke until 12 to 24 hours after an event. Currently in the U.S., there is no rapid, in vitro diagnostic test using protein markers from a blood sample commercially available for use as an aid in the diagnosis of stroke.
Biophan Technologies (West Henrietta, New York) reported the issuance of two new patents by the U.S. Patent and Trademark Office that it said further extend the company's competitive edge in the marketplace for the rapidly emerging field of MRI safety and image compatibility for surgical instruments and implanted devices. One of the patents covers new methods to produce a variety of nanomagnetic coatings to shield medical equipment within an MRI environment. It includes a broad claim regarding how these coatings can be used in a variety of applications, including the reduction of heating in medical devices under MRI; to selectively generate heat for cancer treatments or to control drug release; to reduce image artifacts under MRI; or to enable unimpeded MRI visualization of devices that have been traditionally difficult to see effectively under MRI. The other new patent extends Biophan's protection for next-generation MRI-safe techniques using fiber-optics to power biomedical sensors and therapeutic devices. The patent teaches how a variety of sensors, probes, and medical therapies can be remotely powered and can communicate over a fiber-optic cable by powering the remote probe with short pulses of light. The light energy is converted to electrical energy to power the probes and to send data back to a device where they can be analyzed. This technology can be applied to devices used outside the body or part of an implant-able device.
Conceptus (San Carlos, California), developer of the non-incisional birth control procedure Essure, said it submitted a premarket approval supplement to the FDA to extend effectiveness data on the Essure labeling. The supplemental filing supports an extension of the effectiveness of Essure to four and five years of follow-up and is expected to be unchan-ged from the 99.8% effectiveness rate for one, two and three years of follow-up. There continue to be no pregnancies to date among patients who had been enrolled in the Essure Phase II and pivotal trials, according to Conceptus. The Essure procedure de-ploys a micro-insert into the fallopian tube through the cervix, using a minimally invasive transcervical tubal catheter. The device is designed to elicit tissue growth in and around the micro-insert to form an occlusion in the fallopian tube.
Edwards Lifesciences (Irvine, California) reported receiving conditional approval from the FDA to begin the first feasibility trial of its Cribier-Edwards percutaneous aortic heart valve. Edwards will conduct an initial feasibility study at a single U.S. center involving a randomized, controlled clinical trial of 20 patients who are at a defined level of high risk for conventional heart valve surgery. Under the study's protocol, equal numbers of patients will be randomized to percutaneous aortic valve replacement and balloon aortic valvuloplasty. Upon successful completion of this study, Edwards will initiate a second feasibility trial, which would enroll an additional 40 patients at a limited number of sites. The Cribier-Edwards percutaneous aortic heart valve integrates balloon-expandable stent technology with a replacement tissue heart valve that is compressed onto the balloon. Percutaneous heart valve replacement can be performed without opening the chest and under local anesthesia.
Elekta (Norcross, Georgia) said that FDA clearance of the Elekta Beam Modulator offers lung and spine cancer patients new hope through more accurate treatments that spare more of the surrounding healthy tissue. It noted that such cancers have always been the most difficult to treat due to respiratory motion and the proximity of critical organs. The Elekta Beam Modulator is a precision multi-leaf collimator designed for use with Elekta's medical linear accelerators. It shapes the radiation beam to more closely conform to the exact shape of the tumor, thereby allowing greater accuracy and smaller treatment fields, the company said.
GE Healthcare (Waukesha, Wisconsin) reported at the Arab Health Exhibition and Congress in Dubai, United Arab Emirates, that the company's 0.2T Signa Profile system, an open scanner, now is available with its Excite platform of advanced MRI technology. The company said the Excite platform for the 0.2T Profile System will allow physicians to see more of the human anatomy and function better and faster than ever before, allowing them greater clinical confidence.
Genzyme (Cambridge, Massachusetts) said the first patient has been treated in a new Phase II clinical trial examining the safety and effectiveness of locally delivered gene transfer for patients with peripheral arterial disease (PAD). Genzyme's experimental therapy, using Ad2/HIF-1 alpha, an engineered form of the HIF-1 alpha gene, is designed to promote the growth of new blood vessels and improve circulation in patients' limbs. The randomized, placebo-controlled study will take place at up to 35 medical centers in the U.S. and Europe. It will enroll up to 300 patients diagnosed with severe intermittent claudication, a type of PAD that results in disabling pain or fatigue in the legs, brought on by exercise.
Add to the already extensive list of alternatives for glucose monitoring the NewTek, a new product from Hypoguard (Minneapolis), the diagnostic division of Medisys (Woodbridge, UK). The device is meant to be simpler and more convenient to increase the number of times a diabetic patient tests his glucose daily in order to avoid the serious side effects of not controlling glucose over time, such as blindness, amputations and renal failure. The company said that the NewTek Blood Glucose Monitoring System is unique because it is disposable. It also comes with 100 test strips pre-loaded in the meter. The cost of the NewTek is $54, compared to a price of about $85 for other monitors, the company said. With diabetes patients most often instructed to test their blood glucose levels four times a day, that would mean that each patient would be required to buy a new monitor every 25 days. Another unique aspect of the monitor is that the test strips last for up to six months, whereas with other monitors they only last typically up to three months, she said. With the NewTek, the test strips are only exposed to the environment once, something that can cause the chemicals in such strips to break down and not accurately read glucose levels.
Karl Storz (Culver City, California) has launched its Telecam DX II camera control unit (CCU) to address the market for office-based video endoscopy systems. The company said the Telecam DX II CCU enables physicians to provide high-quality patient care while maintaining cost efficiency. It said the new system is particularly well suited to ob/gyn, urology and ENT practices. The DX II has been designed to enhance image quality, adaptability and the degree of control the physician has over the system. It relies on fiberscope filters to remove moire patterns and pixelation from images generated by flexible telescope scopes. Precise auto-exposure and brightness control are used to maximize the quality of every image. Interchangeable adapters for the Telecam DX II are available in 12 mm, 25 mm, 30 mm and 38 mm focal lengths.
Maxell Corp. of America (Fair Lawn, New Jersey) reported new ultra-durable and ultra-reliable DVD media designed specifically for the medical market. Maxell's medical-grade media incorporates the Maxpro Hardcoat technology to produce en-hanced DVD-R media that delivers the highest level of data protection for up to twice the archival shelf life. The company said its DVD-R is HIPAA- and DICOM-compliant and is "ideal for medical images, patient records, backup and fixed-content storage."
Medical Services International (MSI; Edmonton, Alberta) reported that it has finished all preliminary testing of the VScan Malaria test kit. Test results show that the kit is accurate (greater than 99% of the time), easy to use and gives results in under 20 minutes. The company said it has begun submitting the malaria test kit to regulatory authorities for approval in two countries and will be submitting it for ap-proval in another nine countries within the next 60 days. MSI said that, based on the test results of the VScan Malaria kit and the excellent test results of its other test kits, it expects to receive regulatory approval reasonably quickly.
MedQuist (Mount Laurel, New Jersey) has introduced Protege, its latest digital hand-held dictation solution, which it said is designed to create greater versatility for physicians who need to dictate on the go. The Protege is a compact digital portable recorder that not only captures patient demographics, but offers seamless integration with MedQuist's DocQment Enterprise Platform and DocQment Encore. Protege offers one-button control, a large LCD for efficient status viewing, five user-defined demographic fields, a barcode scanning option to capture demographics and software to map demographics to the appropriate data fields in DocQment Enterprise Platform and DocQment Encore.
Medtronic (Minneapolis) reported the European introductions of the EnRhythm dual-chamber pacemaker and EnTrust implantable cardioverter-defibrillators (ICDs) in single- and dual-chamber versions. Medtronic said the products incorporate several features that provide important patient benefits, including an innovative pacing mode called Managed Ventricular Pacing, or MVP, available in the dual-chamber EnRhythm and EnTrust devices. The EnRhythm device is the first pacemaker to include MVP, which Medtronic first introduced in its Intrinsic ICD last year. The company said MVP promotes natural heart activity by "significantly reducing" unnecessary pacing in the heart's lower right chamber and automatically switching to pace the upper right chamber when normal heart conduction is present. With the MVP mode, automatic switching between dual-chamber pacing and single-chamber atrial pacing can reduce the amount of ventricular pacing to less than 5%, compared to 50% or more with typical dual-chamber pacing, according to Medtronic. The company said a key feature of the EnTrust devices is its ATP During Charging, an advancement of anti-tachycardia pacing (ATP). ATP uses pacing pulses to painlessly terminate fast, dangerous heart rhythms originating in the ventricle. ATP During Charging enables the use of ATP while the EnTrust capacitor charges to prepare for the possible delivery of a high-energy shock if needed. The EnRhythm pacemaker and EnTrust ICDs also offer Reactive ATP, a feature enabling the devices to continually search for opportunities to restore a patient's normal sinus rhythm during long, fast heart rhythm episodes in the atrium. Enhanced diagnostics in these devices provide comprehensive information to assist physicians in the diagnosis of additional types of heart rhythm problems, especially in the atrium.
Miravant Medical Technologies (Santa Barbara, California), which specializes in PhotoPoint photodynamic therapy, said it would conduct a Phase III confirmatory clinical trial of Photrex (rostaporfin, formerly known as SnET2) for wet age-related macular degeneration (AMD), based on a special protocol assessment by the FDA. The placebo-controlled trial, to be conducted outside of the U.S., will enroll a broad range of wet AMD patients. According to the protocol, each study patient will receive Photrex or placebo treatments over the course of nine months. The company said it plans to conduct a primary efficacy endpoint analysis at one year after initial treatment, which, pending positive results, will be submitted for FDA review and subsequent marketing approval. Patients will continue to be evaluated for a second year to confirm the longer-term results established in previous Photrex Phase III studies. Miravant said it expects to begin patient enrollment in mid-2005.
Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said it has received notification that its 510(k) application for the revised and enhanced Quantix/ OR blood flow measurement has been accepted by the FDA for review. In addition, Neoprobe said it has completed the necessary regulatory steps to begin marketing the product in the European Union. The Quantix/OR has been revised to enhance visual ergonomics and to facilitate surgeon use. The flexible probe configuration will permit surgeons to access vessels for measurement during both on- and off-pump bypass procedures. The company said it is planning full product re-introduction at this month's American Association for Thoracic Surgery meeting.
Ortec International (New York) said the FDA has completed a review of the modified Diabetic Foot Ulcer (DFU) Protocol the company submitted to the agency in January and has given Ortec permission to initiate a pivotal trial evaluating OrCel in the treatment of diabetic foot ulcers. The DFU trial is expected to be conducted at up to 25 clinical centers and in-volve about 200 patients. The company said it expects to initiate patient enrollment shortly after receiving approval of its premarket approval application for the use of OrCel in the treatment of venous leg ulcers (VLU), currently under FDA review. Ortec said the FDA has asked it to provide further clarification of information submitted in its PMA application for VLU. The company said it expects to meet with the agency shortly to review the information submitted. OrCel is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair, the company said.
Proxima Therapeutics (Alpharetta, Georgia) said that its MammoSite Radiation Therapy System is expected to be the primary method used to deliver partial breast irradiation (PBI) in a new National Cancer Institute-sponsored study. The National Surgical Adjuvant Breast and Bowel Project and the Radiation Therapy Oncology Group, both clinical trials cooperative groups supported by the NCI, have issued a protocol for the largest study of partial breast irradiation to date. The 3,000-patient study will further define the role of PBI, a treatment option that makes breast conservation therapy available to more breast cancer patients by delivering radiation in just five days. In addition to playing a key role in this study, Proxima said MammoSite is the most widely used form of PBI in the world. MammoSite is a balloon catheter that is placed in the cavity created by a lumpectomy. After implantation, radiation is delivered from a source placed inside the balloon directly to the tissue surrounding the original tumor and is completed in five days.
Regeneration Technologies (RTI; Alachua, Florida), a processor of orthopedic, cardiovascular and other allograft implants, said that its bone paste product has received 510(k) clearance from the FDA. RTI's demineralized bone matrix (DBM) paste products consist of allograft DBM and a gelatin carrier. RTI allograft pastes are used in spinal and orthopedic procedures to fill voids in bone. The pastes are insoluble in fluids at body temperature, so they stay in place during irrigation. The DBM products are packaged and marketed under different names depending on the application, including Regenafil Allograft Paste; Regenafil RT Allograft Paste; Optefil Allograft Paste, Syringe; Optefil RT Allograft Paste, Syringe; Optefil DBM Paste; Osteofil RT DBM Paste and RTI Allograft Paste.
RITA Medical Systems (Mountain View, California) reported that the Radiological Society of North America issued a statement highlighting a clinical study of radio frequency ablation (RFA) treatment for liver cancer in the March issue of Radiology. The publication reports findings indicating that RFA offers an effective first-line treatment for some liver cancer patients who were excluded from surgery. The article reports that RFA provided long-term survival rates for liver cancer patients who are not surgical candidates that are comparable to results obtained with surgical resection in this type of patient. Researchers performed RFA using RITA Medical's radio frequency electrodes on 187 early-stage liver cancer patients with cirrhosis who were not candidates for surgery. The study found 97% percent of the patients survived one year, 71% survived three years and 48% survived five years, which is comparable to results obtained with surgical resection in this type of patient. The results also indicate that RFA patient survival is dependent on the type of cirrhosis and the number of tumors present, the company said.
R2 Technology (Sunnyvale, California) reported the introduction of the ImageChecker LS CAD (computer aided detection) system, designed for low volume film-based mammography sites. ImageChecker LS is a flexible, component-based system featuring R2's CAD technology in a tabletop package. Described by the company as a cost-effective option for low-volume sites, the ImageChecker LS processes a case of four mammogram films in just a few minutes and the results of the CAD analysis can be viewed on any of R2's display solutions, including the CheckMate Ultra flat-panel monitor, or be sent to a printer. The system will also be able to leverage all of R2's advanced workflow and display features, such as connection to mammography reporting systems and PeerView software. The software features are fully upgradeable, the company said.
Rochester Medical (Stewartville, Minnesota) reported the market introduction of its Closed System Intermittent Catheter in both Hydrophilic Intermittent and Antibacterial Hydrophilic Intermittent configurations. The Closed System packages the intermittent catheter with pre-lubricated insertion tip inside a collection bag that permits "touch free" sterile use. The Closed System is first being introduced in the U.S. where, according to industry estimates, such systems account for as much as 30% of domestic intermittent catheter sales. The Hydrophilic and Antibacterial Hydro Closed System Intermittent Catheters are available as single units or in kits that include gloves, antiseptic wipes, and underpad. Rochester Medical manufactures latex- free disposable medical catheters and devices for urological and continence care applications, marketed under its own Rochester Medical brand and under private-label arrangements.
Siemens Medical Solutions (Malvern, Pennsylvania) has received FDA 510(k) clearance for MammoReport(Plus), a mammography softcopy reporting workstation. The clearance allows for the processing of digital computer-aided (CAD) images and mammograms from approved vendors, expanded indications for multimodality viewing, and use with FDA-cleared monitors for the interpretation of lossless compressed images. MammoReport(Plus) is now Windows-based, which enables it to run on syngo, the intuitive software platform from Siemens that delivers powerful networking and post-processing capabilities. MammoReport(Plus) works in conjunction with Siemens' Mammomat Novation(DR) to provide a comprehensive system solution for clinical processes in mammography.
SmartPill Diagnostics (Buffalo, New York), developer of the SmartPill Capsule, a non-invasive, in-gestible medical device that captures biomedical data from within the patient's GI tract, reported that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are now under way at Massachusetts General Hospital (Boston). A total of 130 subjects and five clinical trial sites are expected to participate in 510(k) clinical trials of the SmartPill ACT-I Capsule and SmartPill GI Monitoring System. Of the 130 subjects, 70 are control and 60 are gastroparetic. Gastroparesis is one of the primary GI motility disorders in which the SmartPill ACT-I Capsule will aid diagnosis and management. Temple University Hospital (Philadelphia) also has begun clinical trials, and three other sites will begin clinical trials soon. The 510(k) clinical trials will be completed in May and will lead to 510(k) submission in June.
St. Jude Medical (St. Paul, Minnesota) reported enrollment of the first patients in the ASSERT (ASymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial Pacing Trial) clinical study. The study will follow 2,500 patients for 3-1/2 years to determine if pacemaker-detected AHRE (Atrial High Rate Events) predict an increased risk of stroke in elderly hypertensive patients without previous atrial fibrillation (AF). ASSERT also examines the efficacy of St. Jude's AF Suppression algorithm in helping these patients avoid symptomatic AF. Sinan Gursoy, MD, enrolled the first U.S. patient in the ASSERT study at Naples Community Hospital (Naples, Florida) and Seong-Wook Han, MD, enrolled the first Asian patient at the Keim-yung University Dongsan Medical Center (Daegu, South Korea). The study is being conducted at 125 international clinical centers and coordinated by the Population Health Institute at McMaster University (Hamilton, Ontario). Patients enrolled in the study must be over 65, have a history of hypertension re-quiring drug therapy, and be recently implanted with a St. Jude Medical Identity ADx DR pacemaker with the AF Suppression algorithm. Separately, St. Jude Medical reported the European market launch of the QuickSite 1056T bipolar left-heart pacing lead, which it described as "the world's first cardiac resynchronization therapy (CRT) lead to combine bipolar pacing capability with a composite body for superior handling and an S-shaped distal tip for outstanding stability." St. Jude said the lead represents the next advance in its QuickSite family of left-heart leads. Designed for placement in the coronary sinus, the QuickSite 1056T bipolar lead enables left-ventricular pacing in cardiac resynchronization therapy applications. At 5.5 Fr, the lead body is as small in diameter as the previously available QuickSite 1056K unipolar lead and is designed to work with the St. Jude Medical Epic HF CRT-D, which the company said is the world's smallest high-voltage cardiac resynchronization device, and the Atlas+ HF CRT-D, the world's highest energy output CRT device, to treat heart failure. It also will work with the recently released Frontier II biventricular cardiac stimulation device. The lead has been submitted to the FDA for approval in the U.S.
ThermoGenesis (Rancho Cordova, California) said that Erhan Basad, MD, an orthopedic surgeon, and Detlef Kuhn, MD, an anesthesiologist, studied the use of its CryoSeal autologous fibrin sealant in total knee arthroplasty (TKA) at University Hospital (Giessen, Germany). The results of the study were published in the December 2004 issue of the German orthopedic journal, Orthopadische Praxis. The 21-patient pilot study measured blood loss, cardiovascular stability, pain score, range of motion and wound healing. According to Basad, "the total blood loss in TKA was reduced by 50% when using CryoSeal fibrin sealant. The CryoSeal patients also had better cardiovascular stability, a higher range of motion, less pain and better wound healing than the control group." The CryoSeal FS System is used to prepare hemostatic and adhesive surgical sealants from patient blood in about an hour.
Thoratec (Pleasanton, California) reported that the first patients have been enrolled in the destination therapy and bridge-to-transplantation (BTT) arms of the Phase II pivotal trial for its HeartMate II LVAS (left ventricular assist system) device. This is in addition to the 25 BTT patients that were enrolled in the Phase I trial. Thoratec said that several of the participating centers have received institutional review board approval to participate in the study. The HeartMate II is a next-generation heart-assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure.
Welch Allyn (Skaneateles Falls, New York) reported the availability of the Braun ThermoScan PRO 4000, which it said is the only electronic ear thermometer with a preheated probe and sensor for reliable temperature readings on patients of all ages. Its ExacTemp technology provides an active user feedback system to ensure proper positioning and improved accuracy in calculating temperatures. One of the fastest thermometers for infant to adult patients, the company said the Braun ThermoScan PRO 4000 is an affordable electronic vital signs device that can withstand constant use in a medical practice or hospital setting. The lightweight unit features a prominent memory button to recall the last temperature reading from a patient. There is a storage space for 20 probe covers with an optional base station that holds an additional sleeve of 200 probe covers. It also features electronic security enhancements that discourage theft in hospital environments.
Zoll Medical (Chelmsford, Massachusetts), a maker of resuscitation devices and software solutions, said it has expanded its line of automated external defibrillators (AEDs) with the introduction of the Zoll AED Pro, which received 510(k) marketing clearance from the FDA recently. New features include ECG monitoring with standard ECG electrodes, plus automated capability combined with manual defibrillation, with controlled access for advanced life support (ALS) users. The AED Pro was developed for extreme environments and has an outer housing made of a polycarbonate-siloxane resin the material used in professional football helmets. Zoll said it is the only AED in the industry to pass a 1.5-meter drop test and also has an IPX5 rating for water resistance, which in combination allows the device to perform in harsh weather and other extreme conditions. Zoll said it plans to offer the AED Pro in three models: semi-automatic for basic life support (BLS) providers, semi-automatic with a manual override capability for BLS and ALS; and a manual-only model, suited for skilled users such as physicians.