Another company has entered the home hemodialysis sector and, taking that use even further, is putting its technology on wheels and over the road. NxStage Medical (Lawrence, Massachusetts) this week reported receiving expanded 510(k) clearance from the FDA for its System One portable daily hemo-dialysis device for home use. Weighing in at about 70 pounds and easily movable with a wheeled cart to a van, SUV or other vehicle, System One, backed by the support of a "trained partner," enables a person on dialysis to visit far-away family, pursue Winnebago-style travel, even take a cruise. NxStage bills System One as the smallest, commercial hemodialysis system now available, and the expanded 510(k) means the company can now grow its market beyond the hospital sector to dialysis clinics and their patients who can manage their own dialysis at home.

With a footprint somewhat like a early-stage personal computer, System One also features a reduced and simplified infrastructure to provide the patient mobility that NxStage will focus on in its marketing. Joe Turk, senior vice president, noted that the system's ability to be moved from place to place received its first demonstration in hospital care sites "where it is really important to be portable, to take the machine and fluids [necessary] to the bedside." That portability also is enhanced by use of standard electricity and water, he told The BBI Newsletter, essentially allowing a sort of plug-and-play use. He puts that portability against the home dialysis system from Aksys (Lincolnshire, Illinois), a breakthrough home dialysis system approved by the FDA in 2002, but refrigerator-sized and weighing in at hundreds of pounds.

Agency approval for hospital use for System One was granted in 2003, but Jeffrey Burbank, president and CEO of NxStage, told BBI that "the company was built on the idea of servicing both markets, and it was just most appropriate to go to the hospital first." The target market for the expanded use is dialysis clinics, Burbank says, is those clinics identifying patients who can be trained on the machine, with NxStage providing supportive marketing programs.

Elsewhere in the product pipeline:

Adlyfe (Rockville, Maryland) is continuing on a course begun in 2003 to develop tests for testing cattle, blood screening and possibly for a clinical diagnostic for protein-folding diseases. The test that is being developed to provide earlier diagnosis of "mad cow" disease was developed by Cindy Orser, vice president of research and development at Adlyfe. Adlyfe's technology uses memetics, or peptides, for "looking for shape changes in proteins," according to CEO Alan Rudolph. "Prion disease is story of protein-folding or shape change from a native conformation to a misfolded form," he said. The company said new results from the test would be published in the Journal of Peptides. It also said that it has demonstrated detection of prion diseases in brain tissue and blood of cattle, sheep and humans in clinical laboratory sampling.

Advanced Neuromodulation Systems (Dallas) reported an expanded U.S. market launch of its new flagship rechargeable implantable pulse generator (IPG) system, the Eon Neurostimulation System. The company said the Eon offers "a significant step-up in IPG capability," including high power, longer recharge intervals, broad programming capability and systems configuration flexibility. The Eon IPG can also power up to 16 independent electrodes in a dual eight-electrode lead configuration, similar to the company's flagship Renew radio frequency external power system. Easy to implant, the Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.

Aspect Medical Systems (Newton, Massachusetts) said studies presented in June at the Alzheimer's Association's International Conference on Prevention of Dementia in Washington demonstrated that its brain-monitoring technology identified patients at varying stages of Alzheimer's disease and correlated with the severity of their dementia. Three studies collectively examined 111 patients ranging in age from 61 to 90, including 84 healthy subjects, 16 patients with mild Alzheimer's and 11 patients with moderate disease. Cognitive function of healthy subjects was evaluated quarterly over the course of one year using Aspect's brain monitoring technology and two standard tests. Using a sensor placed on the patient's forehead, the Aspect technology translates information from the electroencephalogram into a single number that represents a level of cognitive function. Data from these studies showed that a high number indicated healthy cognitive function, while lower values correlated with the severity of the disease.

Bausch & Lomb (Rochester, New York) said its PureVision soft contact lens is now available in the U.S. The new lens is designed to correct spherical aberration, a condition that researchers estimate affects nearly 70% of the population, in addition to correcting for nearsightedness and farsightedness. PureVision lenses are made from balafilcon A, the company's silicone hydrogel material.

BioArray Solutions (Warren, New Jersey), a molecular diagnostics company, reported the FDA 510(k) clearance of a new immunoassay for the simultaneous detection of six antibodies to different ex-tractable nuclear antigens (ENA). The ENA IgG BeadChip Test System, for use on the company's Array Imaging System (AIS 400), uses BioArray Solutions' BeadChip format to simultaneously detect multiple analytes of interest on a tiny silicon chip holding a planar array of color encoded microparticles. The AIS 400 fully automates image acquisition and integrated analysis to rapidly generate assay results.

Biotronik (Lake Oswego, Oregon) reported receiving FDA approval to market its Protos CLS family of single-chamber and dual-chamber pacemakers as responding to physiologic demands instigated by exercise and acute mental stress, a claim it said serves to differentiate its systems from other companies selling the devices in the U.S. Technology embedded in the company's pacemakers, called Closed Loop Stimulation (CLS), is designed to integrate with the natural control centers of the heart to provide a physiologic and appropriate heart rate. The company originally received approval to market its Protos DR and VR pacemakers from the FDA in late-December 2002, but this newest approval allows the company to make marketing claims that its pacemakers can respond to varying levels of stress, more closely mimicking the true functions of the human heart. Traditionally, rate-adaptive pacemakers sense that patients are in motion or that they have changed their respiration rate in order to increase or decrease heart rates. Protos with CLS measures contraction dynamics in the right ventricle, thereby integrating the heart rate back into the cardiovascular control loop. In such cases, rate adaptation is accomplished by interpreting what the autonomic nervous system really needs in situations involving exercise and other demands, and then adjusts automatically to avert any possible over-response or under-response. Biotronik also reported FDA approval of the ICS 3000. The programmer features a 12-inch high-resolution, high-contrast, lightweight LCD touch-screen color display; jam-resistant thermal printer; CD-RW drive; USB ports; and 30 gb hard drive. The ICS 3000 also incorporates a detachable screen to simplify and improve follow-up efficiency, essentially transforming the programmer into a tablet PC, the company said. The ICS 3000 will be made available to U.S. hospitals and clinics that implant Biotronik cardiac pacemakers and implantable cardioverter defibrillators.

Boston Scientific (Natick, Massachusetts) reported the U.S. launch of its Matrix2 360-degree Detachable Coils, which have been cleared by the FDA for the treatment of brain aneurysms. The Matrix2 360-degree Detachable Coils feature a new 360-degree complex shape designed to allow greater conformability and more uniform distribution within intracranial aneurysms. The design includes 1.5 loops at the beginning of the coil that are 25% smaller than the overall coil diameter. This multi-diameter design is intended to offer more precise, controlled delivery and facilitate first-time placement. The smooth biopolymer coil surface also decreases coil-on-coil friction by 35% over the company's first generation coils in order to facilitate coil delivery and promote aneurysm packing. The Matrix2 coils leverage established GDC 10 technology, which has already been used to treat more than 10,000 patients worldwide. The product line now offers coil diameter sizes ranging from 2 mm to 24 mm and coil lengths from 4 mm to 40 mm.

Cardima (Fremont, California) said it has filed an investigational device exemption (IDE) with the FDA to use its linear ablation technology to create continuous linear lesions in the left atrium of the heart for the treatment of chronic atrial fibrillation. When combining both the Intellitemp and the Revelation T-Flex, doctors will have control of where placed, what shape, and how long any specific lesion they create within the heart, while saving procedure time.

CardioDynamics (San Diego), a manufacturer of impedance cardiography (ICG) technology, reported that the FDA has granted 510(k) clearance for the second phase of the BioZ Dx which it said is the first ICG device with 12-lead electrocardiography (ECG). The BioZ Dx is the result of a co-development partnership between the company and Philips Medical Systems (Andover, Massachusetts) and gives physicians the ability to assess the patient's electrical and mechanical cardiovascular status in one platform. Existing BioZ Dx customers will be able to add the 12-lead diagnostic ECG capability with a field upgrade. With four dual sensors, the ICG portion of the BioZ Dx provides 12 parameters about the heart's pumping ability, including the amount of blood ejected by the heart each minute, the resistance it has to work against, and the amount of fluid in the chest.

Cardiogenesis (Foothill Ranch, California), a developer of surgical products and accessories used in angina-relieving procedures, said it has submitted its definitive percutaneous myocardial channeling (PMC) trial protocol to the FDA in an investigational device exemption application. In early June, Cardiogenesis received a Letter of Agreement from the FDA that detailed its acceptance of the key elements of trial design, endpoints and patient criteria that forms the basis of the PMC trial protocol.

DePuy Mitek (Norwood, Massachusetts), a Johnson & Johnson (New Brunswick, New Jersey) company that manufactures surgical sports medicine devices, reported the worldwide introduction of Orthocord Suture, a high-strength, flexible orthopedic suture for knee and shoulder repair. Orthocord Suture is made of braided high-molecular-weight polyethylene, which gives it 55-pound straight tensile strength, and polydioxnone, which provides flexibility and suppleness. The suture also is coated with a proprietary material to increase the slide-ability of the suture and enhance its knot-tying characteristics and making it easier for a knot to slide down a cannula during surgery. DePuy Mitek's Spiralok absorbable suture anchor, its Fastin RC metallic suture anchor for rotator cuff repairs, and the Lupine loop anchor for instability procedures all will be pre-loaded with Orthocord Sutures.

DiaDexus (South San Francisco, California) said that the FDA has granted the company marketing clearance for the PLAC test, making it the first blood test to aid in predicting risk for ischemic stroke associated with atherosclerosis. The PLAC test measures an enzyme in the blood called lipoprotein-associated phospholipase A2 (Lp-PLA2). Because Lp-PLA2 and systolic blood pressure levels are additive in their ability to predict stroke risk, the PLAC test can help identify stroke-prone hypertensive patients.

DOBI Medical International (Mahwah, New Jersey) said it has entered into contracts with 17 U.S. sites in connection with its clinical trial studying its ComfortScan system. The ComfortScan system has been installed in 16 of those sites, and other locations will receive systems in the near future. The clinical trial is the final element of the company's premarket approval application to the FDA. The ComfortScan system is designed as an adjunct to screening mammography to aid in breast cancer diagnosis. It is a non-invasive, non-ionizing device that uses light-emitting diodes, sophisticated imaging processing and display software, and gentle external pressure to identify angiogenesis, the growth of new blood vessels, in the breast. Angiogenesis has been widely linked with the growth and development of malignant tumors, the company said.

ELA Medical (Le Plessis Robinson, France), a Sorin Group company and manufacturer of cardiac rhythm management implantable and diagnostic systems, reported the first clinical implants of Ovatio DR, its new dual-chamber implantable cardiac defibrillator (ICD), which features the AAIsafeR 2 pacing mode. ELA's AAIsafeR 2 mode promotes the patient's intrinsic conduction by limiting unnecessary pacing to the ventricle to 0.1% in patients who have normal heart conduction. The company said the rollout of the complete Ovatio ICD family is expected in 4Q05 together with a new generation of defibrillation leads.

Gambro Renal Products (GRP; Lakewood, Colorado) reported receiving FDA 510(k) clearance for a treatment that removes toxins from the blood in cases of drug overdose and poisoning. Gambro's Molecular Adsorbents Recirculating System (MARS) Therapy is a blood detoxification system used in conjunction with an extracorporeal device for the treatment of drug overdose and poisonings. MARS Therapy uses albumin as the primary agent for removing dialyzable (unbound) toxins. During MARS Therapy, a patient is connected to the Gambro Prisma system, a continuous renal replacement therapy system, which pushes blood through an extracorporeal circuit into a MARS Flux filter. Based on a process called albumin dialysis, the filter removes toxins with an affinity for protein by diffusion into a recirculating human albumin solution. Gambro Renal said that the MARS Therapy will be available in the U.S. "toward the end" of 2005 for drug overdose and poisoning treatment.

GE Healthcare (Waukesha, Wisconsin) reported launch of its new family of LightSpeed computed tomography (CT) systems that now include exclusive Volara digital Data Acquisition System (DAS), and the Xtream FX workflow platform. The rollout was made at the 7th Annual International Symposium on Multidetector-Row CT (MRCT), presented by the department of radiology at the Stanford University School of Medicine. The LightSpeed VFX Series will use the Volara digital DAS technology and Xtream FX workflow platform, developed for GE's LightSpeed VCT. The company said, "clinicians will be able to tap many of the unprecedented images quality and productivity capabilities of the LightSpeed VCT on GE's 4 slice, 8 slice and 16 slice CT systems."

HIFU (Charlotte, North Carolina), a development-stage company, said Health Canada has granted the company a Class III medical device approval for the use of the Sonablate 500 in Canada for the treatment of prostate disease with high-intensity focused ultrasound (HIFU). The Sonablate 500, manufactured by Focus Surgery (Indianapolis), is a non-invasive device that uses HIFU to destroy tissue within the prostate without affecting surrounding tissue.

Jarvik Heart (New York) the company whose namesake, Robert Jarvik, MD, invented the original artificial heart implanted in Barney Clark more than 20 years ago said last month that it has received full approval from the FDA to begin a pivotal trial of the Jarvik 2000 FlowMaker, for bridge-to-transplant use, with an eye toward ultimate approval of the ventricular assist device (VAD) as a destination therapy. The pivotal study is designed to establish the safety and efficacy of the Jarvik 2000 in supporting severe heart failure patients while they await the availability of a donor heart for transplant. In Europe, the Jarvik 2000 has earned the CE mark for both bridge-to-transplant and destination therapy, and has been supporting its first lifetime-use patient for more than five years with what the company called "an excellent quality of life." The company said it plans to submit an application to the FDA later this year for a pivotal study of the Jarvik 2000 for use as a destination therapy in the U.S. under a protocol designed for the treatment of heart failure in earlier-stage patients. Jarvik Heart said that using the mechanical heart earlier before patients suffer too much damage to other organs is expected to help them recover more rapidly to a normal life. Jarvik said, "VADs should be used earlier for lifetime use or for very long-term bridge-to-transplant type of use that we have named maintenance therapy." Up to 160 patients will be enrolled in the pivotal study at 25 U.S. medical centers. The study's launch follows completion of a pilot study of the Jarvik 2000 in the U.S., which enrolled 63 patients at eight medical centers.

Medtronic (Minneapolis) reported the U.S. introduction of the EnTrust implantable cardioverter defibrillator (ICD). The company said the EnTrust single- and dual-chamber devices expand its premium line of ICDs, which are designed to treat patients with ventricular tachycardia (VT) that can lead to sudden cardiac arrest. The EnTrust ICD family was approved by the FDA on June 14. EnTrust is the first ICD to offer ATP During Charging, a Medtronic-exclusive feature that automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while concurrently preparing to deliver a shock if needed. The company said recent clinical studies have shown that 90% of fast heart rhythms have the potential to be terminated by pacing alone. It said the use of this anti-tachycardia pacing to stop fast heartbeats has been clinically proven to eliminate three out of four shocks with painless therapy, potentially improving patient quality of life. The EnTrust dual-chamber ICD also helps reduce inappropriate therapy by better identifying episodes of supraventricular tachycardia, which may ensure that patients receive appropriate shocks. The dual-chamber version also incorporates a pacing mode called Managed Ventricular Pacing (MVP), which promotes natural heart activity by "significantly reducing" unnecessary pacing in the heart's ventricle. This algorithm can reduce the amount of ventricular pacing to a median of 0.1%, compared to 50% or more with typical dual-chamber ICDs, Medtronic said. MVP has been available in several Medtronic pacemakers and defibrillators since 2004. Medtronic also reported that it received FDA approval, via a premarket approval application, for its SynergyPlus+ neurostimulation system for chronic pain. The new device is the newest "pain pacemaker" to join its family of implantable chronic pain therapies. It was designed to give patients more control over the delivery of stimulation that blocks pain signals from reaching the brain while performing a variety of daily activities. The previous generation of the Synergy has only one program option. The company said the SynergyPlus+ has the greatest number of program options (up to 26) available of any non-rechargeable neurostimulation system on the market today. Using a small, hand-held remote control programming device, patients can choose among multiple settings that are preset by a physician to address pain levels associated with different daily tasks.

Medtronic Vascular (Santa Rosa, California) reported the completion of patient enrollment for the VALOR (Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical trial, a pivotal study evaluating the safety and efficacy of the Talent thoracic stent graft system for the treatment of thoracic aortic diseases. VALOR is a large thoracic stent graft study, with three arms and 359 patients at 40 clinical centers in the U.S. It is a prospective, non-randomized, multi-center trial with a primary endpoint comparing "all cause" mortality at 12 months for open surgical repair against minimally invasive endovascular stent treatment using the Talent stent graft system. Medtronic will use the results of the VALOR trial for submission to the FDA for approval of the Talent system. Final VALOR trial results may be available in 2006.

Metrika (Sunnyvale, California), a manufacturer of diabetes monitoring products, said it received FDA marketing clearance for its new A1cNow INView multi-test system for monitoring hemoglobin A1C the gold standard indicator of diabetes control. Used in a physician's office or at home, the small monitor provides immediate, lab-quality quantitative A1C test results for determining a person's average blood sugar level over the past two or three months. The test requires only a 10-microliter whole-blood sample via finger stick to obtain lab-quality results.

Roche Diagnostics (Indianapolis) reported that it has received FDA clearance for its Elecsys PreciControl Tumor Marker control solution. The tumor marker provides laboratory professionals with the same control for six different tumor marker tests. The Elecsys PreciControl Tumor Marker control adds to Roche's growing tumor marker portfolio that includes prostate-specific antigen; free prostate-specific antigen; Alpha-fetoprotein; carcinoembryonic antigen, CA-15-3, which monitors treatment of breast cancer and recurrences; and CA-125, which monitors the treatment of ovarian cancer. Because one control can be used with all of the tests, laboratory professionals could see an increase in efficiency and productivity there is no need to switch controls in order to run different tests. Roche Diagnostics has filed a submission with the FDA for its Elecsys CA 19-9 assay, and that submission is pending.

Second Sight (Sylmar, California) is working on the second generation of an implantable device an artificial retina that it believes will help people, struck by blindness due to retinal degenerative diseases, to see again. Six people have already been implanted with the first generation of the device, which employs 16 pixels, and Second Sight expects to implant the second generation, a 60-pixel device, within six months. "Our first generation only had 16 pixels 16 spots of light which was really done just as an experiment, but it turned out that even by scanning, the patients could use the 16-pixels to find objects to tell the difference between objects and so on," Second Sight President and CEO Robert Greenberg, MD, PhD, told BBI. The artificial retina works by acquiring power and data from external electronic devices that electrically stimulate the retina through an array of electrodes. Greenberg said he expects the second generation of the artificial retina to provide "enough useful vision" to be the company's first commercial product.

Swissray International (Lizabeth, New Jersey) reported that it has received FDA 510(k) clearance to market its newest direct digital radiographic system, the ddRCombi Trauma. The ddRCombi Trauma is engineered to provide fast, high-quality digital imaging in the emergency department or trauma center. With this system, traumatized patients can be imaged from head to toe without being moved. The ddRCombi Trauma features a fixed table with elevating base, four-way floating top, and automatic positioning of the detector for cross-table imaging with the push of a single button on a wireless hand-held remote control. The table top easily slides away for access to the digital detector for wheel chair and upright exams. The system includes the eXpert4000 control and communication center. A memory function enables fully programmable user functions, including automatic positioning for every body part as well as from existing images on SwissVision. It is fully remote monitoring capable.

Thermage (Hayward, California) said research published in the June/July issue of Facial Plastic Sur-gery Journal further validates the unique mechanism of action produced deep within the skin by its ThermaCool System's monopolar radio frequency (RF) energy. While the immediate tissue tightening and dermal collagen remodeling effects produced by the ThermaCool system have been well established since the device's introduction in 2002, lead author Manoj Abraham, MD, of New York Medical College (Valhalla, New York) found that selective heating and tightening of the fibrous "threads" that run through the fat better explain visible contouring changes that are unique to the Thermage Procedure. Abraham said the research findings document the ability of monopolar RF to selectively heat and tighten the natural fibrous septae threads that give facial skin its structure and shape. Last year, the company introduced and trained its physician users on an enhanced treatment algorithm that supports the role of selectively heating fibrous septae. The ThermaCool device is cleared by the FDA for the treatment of facial wrinkles and rhytids and for treatment of the periorbital area.

ThermoGenesis (Rancho Cordova, California) said that enrollment is now complete for its pivotal U.S. 150-patient blinded, randomized, multi-center clinical trial for the CryoSeal Fibrin Sealant System. This pivotal trial evaluated the safety and efficacy of the Fibrin Sealant prepared by the CryoSeal FS System as an adjunct to hemostasis for patients undergoing liver resection surgery. The data will be compiled and included in a PMA submission, expected to be filed in calendar 2005. The CryoSeal FS System prepares both components (cryoprecipitate and thrombin) of CryoSeal Fibrin Sealant from a single unit of autologous human plasma in about an hour. Once prepared, the CryoSeal Fibrin Sealant may be frozen or used immediately as a hemostatic agent for patients undergoing liver resection surgery.

Toshiba America Medical Systems (Tustin, California) unveiled the Xario ultrasound system, its latest cardiac ultrasound offering, in June at the American Society of Echocardiography meeting in Boston. The Xario ultrasound system quickly and accurately delivers the high-quality images necessary to distinguish tiny cardiac and vascular structures, while remaining affordable for hospitals and clinics where resources for new technologies may be dwindling. The Xario ultrasound system delivers superior images to ensure diagnostic confidence. Among its many standard features, including Filter and Pulse Subtraction THI and Harmonic TDI, the Xario provides premier image quality during routine examinations of the heart, as well as when imaging difficult-to-scan patients. In addition, the Xario provides a comprehensive optional Stress Echo package. The Xario ultrasound system provides cardiologists with flexible solutions that can be customized based on the individual needs of each user. Cardiologists can print, store and perform network transfers of patient data, still images, clips and SR. The system supports all seven classes of DICOM connectivity, and the patient browser enables cardiologists to review studies and export them to PC-compatible formats at the touch of a button. The system also includes a CDR, integrated DVD recorder and DVI interfaces.

Zarlink Semiconductor (Toronto/San Diego) has introduced what it calls the world's only transceiver chip designed exclusively for wireless communication systems that link implanted medical devices with base stations. The new chip, the ZL70100, enables an implanted device/base station link up to a distance of 2 meters, thus greatly extending the range of the most advanced previous generations of this general type of communication system in the device arena. Until now, the most advanced versions of the technologies linking implantable devices to an outside-the-body receiver have had a range of just a few centimeters, Zarlink said. And they come with a variety of limiting disadvantages, among the most obvious of which is the need for placement of a system coil on a patient's skin, placing it too close to or even within the sterile field during an implant procedure. Besides having 10 times the range of previous chips, the new Zarlink device offers a much higher data rate but with, the company said, "half the power consumption."

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