SynCardia Systems (Tucson, Arizona), a developer of cardiac replacement and assist devices, receiving final FDA approval in mid-October for its CardioWest Temporary Total Artificial Heart (TAH-t) – formerly the CardioWest Total Artificial Heart – as a bridge to heart transplantation. The approval is for use in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure. The approval came after the company successfully passed an audit inspection of its manufacturing, the final step in a modular filing procedure, said Marvin Slepian, MD, president and CEO of SynCardia and a professor of medicine at the University of Arizona (also Tucson). The company said this is the first FDA approval for a temporary total artificial heart, though the agency, in its "talk paper" announcing the approval, referred to the device as a "partial" artificial heart.

The TAH-t is a pulsating bi-ventricular device implanted into the chest to replace the patient's left and right ventricles, and it is sewn to the patient's remaining atria. By means of tubes through the patient's chest wall, each ventricle is connected to a drive console that provides pulsed pressurized air and enables device monitoring. One of its antecedents is the original Jarvik heart, but Slepian told The BBI Newsletter that there have been a whole range of changes in the device and the selection and handling of patients. Overall, he called the agency approval the culmination of a "40-year project" and the result of "a baton-passing exercise."

The FDA approved the SynCardia device based on a review of clinical studies of safety and effectiveness and the recommendation of the FDA's Circulatory System Devices Advisory Panel last March. The panel vote was 10 in favor of approval, with conditions, and one abstention.

Elsewhere in the product pipeline:

Analogic (Peabody, Massachusetts) reported the formal market release of the Lifegard ICG Patient Monitor. The Lifegard ICG provides continuous cardiac output by measuring the ICG (impedance cardiogram) to calculate cardiac output. The monitor displays 12 additional direct and derived hemodynamic parameters plus non-invasive blood pressure and heart rate. It also displays both the electrocardiogram and ICG waveforms on a bright color display.

AngioScore (Alameda, California) reported receiving the CE mark for its flagship AngioSculpt scoring balloon catheter. The AngioSculpt scoring balloon catheter is a line of coronary angioplasty catheters comprising an angioplasty balloon surrounded by a system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands. The device is intended for the treatment of a hemodynamically significant coronary artery stenosis, for the purpose of improving myocardial perfusion.

Astro-Med (West Warwick, Rhode Island) said its Grass-Telefactor Product Group has introduced a networked video camera control system to be used in the monitoring and diagnosis of epilepsy. Designed primarily for long-term monitoring, the new software-controlled camera system also can be used in sleep monitoring and routine electroencephalogram laboratories. The networked Camera Control System combines proprietary software and video equipment for camera control via software using TCP/IP communication. The Camera Control Software can be installed on any PC that is on the local area or wide area network in the hospital.

B. Braun Medical (Bethlehem, Pennsylvania) said it was granted a patent for its wireless communications pump technology, Outlook. While Outlook pumps will retain manual functionality and the ability to read bar codes to help eliminate errors, wireless capability allows a third method of data entry as well as data retrieval, the company said. The Outlook 300 model, planned to be available by year-end, will allow transmission of infusion data across a hospital's existing wireless network. During the first half of 2005, the company said it plans to introduce the Outlook 400 model, which has the capability of receiving wireless infusion data from compatible point-of care systems.

BioView (Rehovot, Israel) reported FDA clearance of its automated scanning microscope and image analysis system, the Duet System, for amniotic cells stained by FISH (fluorescent in situ hybridization). The Duet had previously received FDA clearance for hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH prepared from cell suspension for in vitro diagnosis use, as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on particular color, intensity, size pattern and shape. This new application for the Duet System now will assist caregivers to diagnose and monitor patients with genetic abnormalities as well as hematological pathologies. According to BioView, use of its system generates increased information that is not provided by any other commercial technology while providing fast, accurate and highly sensitive results.

Privately held Bone Solutions (BSI; Dallas) said last month that its magnesium-based, bio-absorbable adhesive compound has successfully tested against leading products in the orthopedic cement/filler markets, providing what it said is "significantly superior" strength compared to these products and thus potentially eliminating the need for screws, plates and other traditional tools used widely in orthopedic surgeries. The company said that early animal studies have demonstrated that the compound is able to attach tendon to bone and bone to bone – suggesting, it said, the potential to alter the way knee and shoulder surgeries are performed in humans and animals. It estimated that the potential market for all the potential orthopedic applications exceeds $1.5 billion. "We believe this has the potential of revolutionizing certain orthopedic surgical procedures, starting with the ACL market, and that of extremities, since our 'solution' reduces the time it takes for hand, shoulder or ankle injuries to heal," said Thomas Lally, chairman, president and CEO. "It also could prove invaluable to the sports medicine industry – including both humans and animals," he said. Studies have thus far shown that the bone adhesive could take the place of screws used in orthopedic surgery.

BrainLAB (Munich, Germany) reported the first treatment of a liver tumor patient with the company's new tumor tracking and targeting system, ExacTrac X-Ray Adaptive Gating. The patient was treated at the university hospital of the Vrije Universiteit Brussel (Brussles, Belguim). "To further enhance our system for the treatment of lung and liver tumors, BrainLAB has now complemented its X-ray-based positioning technology with 'gating'," said Stefan Vilsmeier, CEO of BrainLAB. "With this new feature, physicians are able to confidently address tumor movement caused by the patient's breathing. 'Gating' allows the radiation beam to be synchronized with the patient's breathing frequency. This means that physicians are able to interrupt the treatment beam in milliseconds and only continue to irradiate when the tumor is located exactly in the path of the beam."

Cook (Bloomington, Indiana) said last month that it was readying roll-out of its next-generation Zenith FLEX AAA Endovascular Graft for abdominal aortic aneurysms (AAAs), together with the recently FDA-cleared delivery system, the H&L-B One Shot Introduction System. The company received FDA clearance of the Zenith FLEX system, which it terms "the only hand-made device with a wide array of components and sizes" – in May, but it has awaited FDA clearance of the delivery system before rollout. Barry Thomas, director of endovascular therapies for Cook, said the problems other companies have had with their AAA products largely had to do with. with device delivery, which he said Cook has taken pains to avoid. "We developed this [next generation] around the delivery system, so you can put it exactly where you want it and deploy it correctly." The Cook device has two more steps than any other device, including the use of "trigger wires" which keep the device from expanding until it is manipulated into place more accurately "up to the last minute," he said, and a "top cap" which holds the device's stent at the top of deployment "exactly where you want it." The H&L-B One Shot Introduction System also features the new Captor Hemostatic Valve to inhibit blood reflux and air aspiration. A Flexor introducer uses a sheath construction combining optimal flexibility with maximum resistance to sheath kinking or compression.

Cordis Endovascular (Warren, New Jersey), a division of Cordis, a Johnson & Johnson company, reported that a patient in Newport Beach, California, was the first to enroll in its surveillance study of its carotid artery stenting system for treatment of patients with carotid artery disease at high-risk for adverse events from carotid endarterectomy. The FDA granted permission to Cordis Endovascular to initiate a surveillance study that will provide ongoing data about the carotid stenting procedure. When fully implemented, the surveillance study will enroll 1,500 patients at 112 sites in the U.S. The FDA also granted permission to the company to launch its comprehensive training program for physicians and other relevant healthcare professionals, called CASES (Cordis Carotid Artery Stenting Education System). Training will include didactic review, case observations and simulation training, and hands-on experience at a regional education center.

dj Orthopedics (San Diego) reported the release of a new, multifunctional back bracing system, the BOA (Back Orthotic Appliance). The BOA is designed to address a variety of clinical spinal indications, including post-operative support after spinal fusion and spinal laminectomy, acute and chronic low back pain and disc herniation or degeneration. dj Orthopedics has exclusive worldwide distribution rights (except for certain U.S. states) for the BOA, which is manufactured by Pacific Medical. The BOA back brace features a lacer design that incorporates a tear-drop channel for a consistent and uniform adjustment of the compression panels from a single pull handle, and the brace's lightweight and low-profile design enables it to be worn under, between or over clothing. The brace also offers an optional rigid shell attachment that enables a user to offload the weight placed on the lower back following injury, strain, sprain or surgery. Without the rigid shell, the BOA back brace may be worn for support and stability.

Digirad (Poway, California), a provider of solid-state imaging products and services to physician offices, hospitals and imaging centers, has introduced the Cardius-3 imager, which the company said represents a new era in nuclear cardiac imaging. The Cardius-3 imager is a solid-state nuclear gamma camera with three detectors that features high-count imaging statistics. Digirad said it is the first and only company to offer a dedicated, cardiac triple-head gamma camera. The company said the Cardius-3 imager's detection capability meets industry guidelines for count density at shorter acquisition times compared to other in-office, small-footprint, dual-head systems. The imager is comprised of a solid-state nuclear gamma camera with an upright imaging chair and an acquisition/processing station.

EP MedSystems (West Berlin, New Jersey) reported receiving FDA market clearance for an enhancement to its EP-4 Computerized Cardiac Stimulator allowing the physician to stimulate the heart using either constant current or constant voltage output. The enhanced stimulator now can be used in both EP (electrophysiology) diagnostic studies of the heart and pacemaker implantations where measuring voltage thresholds are fundamental. The stimulator is integrated with the company's EP-WorkMate Electrophysiology Workstation, as well as other diagnostic technologies used in the monitoring and diagnosis of arrhythmias in the heart.

GE Healthcare (Waukesha, Wisconsin) reported the introduction of a new high-performance compact ultrasound system, Logiq Book XP, with expanded capabilities for the emergency room and surgery. Weighing just 10 pounds, the easy-to-use ultrasound system has advanced imaging and connectivity features that enable clinicians to scan patients virtually anywhere. Logiq Book XP is built on GE's software-based TruScan architecture and miniaturization technologies to provide the capacity to store more than 30,000 clinical images. The system provides fast acquisition speeds and new digital beam-former transducer technologies to deliver high quality images for a range of applications.

Guidant (Indianapolis) reported the FDA clearance and U.S. launch of its Vasoview 6 Endoscopic Vessel Harvesting System for extracting vessels used by surgeons to perform coronary artery bypass procedures. The Vasoview 6 system allows the clinician to remove a vein from the leg or an artery from the arm through one small incision. Endoscopic vessel harvesting has been shown to reduce postoperative pain, recovery time, infection rates and scarring, allowing patients to walk sooner and more easily after surgery. The Vasoview endoscopic vessel harvesting systems have been used in nearly 400,000 patients to date. The company's sixth-generation Vasoview System incorporates improvements to enhance performance and make the system easier to use.

Guilford Pharmaceuticals (Baltimore) reported that it has received notice from the FDA that Gliadel Wafer (polifeprosan 20 with carmustine implant), the company's brain cancer treatment, is entitled to seven years of market exclusivity for the treatment of patients with malignant glioma undergoing primary surgical resection. The seven-year period of exclusivity under the Orphan Drug Act commenced on the date of approval in February 2003 and extends until February 2010.

Inamed (Santa Barbara, California) and Genzyme (Cambridge, Massachusetts) reported FDA approval for Hylaform Plus (Hylan-B gel), a large particle size hyaluronic acid-based dermal filler that is indicated for the correction of moderate to severe facial wrinkles and folds. Hylaform Plus is manufactured by Genzyme and Inamed is the exclusive worldwide marketing and distribution partner.

MacroPore Biosurgery (San Diego) reported that it has received FDA 510(k) clearance for a point-of-care adipose tissue extraction system, which is designed to extract and collect adipose tissue. The claims for the adipose tissue extraction system specifically cover the fragmentation, emulsification and aspiration of soft tissue for multiple surgical specialties. The company said the clearance is one of several components of its system that will require FDA approval prior to commercialization.

Medical Services International (Edmonton, Alberta) has begun shipping its VScan HIV rapid test kits to its distributor in Indonesia, who will handle the overall distribution of the test kits in that country. Based on Indonesia's infection rate for HIV, the company expects to deliver up to 500,000 HIV test kits in the first year, increasing to 1,500,000 kits in the second year. The VScan rapid test kit is a single-use, cost-effective test for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, West Nile virus and Dengue fever.

Matritech (Newton, Massachusetts) reported the issuance of U.S. patent No. 6,803,189, covering methods of using a nucleic acid sequence encoding for the NMP179 protein to detect cervical cancer. Its partner, Sysmex (Kobe, Japan), is conducting preclinical trials of a new automated cervical cancer testing system incorporating the NMP179 technology. Upon successful completion of the preclinical and anticipated clinical trials, the company said it expects that Sysmex will make the technology available in the U.S. in 2006.

Medtronic Vascular (Santa Rosa, California) reported FDA approval and full U.S. market availability of the Driver Coronary Stent System on the Multi-Exchange (MX2) Coronary Stent Delivery System. The new MX2 Delivery System features a low-profile, flexible shaft that is compatible with short guide wires. The system facilitates fast and easy wire exchange during an angioplasty or stenting procedure and does not require an assistant to operate. The system allows the operator to exchange wires during the procedure, while maintaining the wire position at the lesion site and without removing the entire system. Medtronic said it intends to expand the use of MX2 platform to other products, including the Sprinter and NC Stormer balloons.

Mentor (Santa Barbara, California) said it has received CE-mark approval for its Contour Profile Becker 35 Expander/Implant, the only shaped combination tissue expander and long-term breast implant that can be temporarily over-expanded post-operatively in breast reconstruction cases. The company said the Contour Profile Becker 35 is the only shaped expander/implant that is designed for use as both a tissue expander and a long-term breast implant in one device, thereby minimizing the need for a second surgery. The product is filled with saline via a removable tube through a remote injection dome. The fill tube and dome can be left in place for up to six months. Upon removal of the fill tube and dome, the valve system of the tissue expander is safely sealed, turning the device into a long-term implant.

Nanogen (San Diego) reported that its SynX (Toronto) subsidiary was issued U.S. patent No. 6,780,606, "Method for Diagnosing and Distinguishing Stroke and Diagnostic Devices for Use Therein," by the U.S. Patent and Trademark Office. The patent relates to a diagnostic device that measures protein biomarkers to determine whether a patient has had a stroke and, if so, whether it was an ischemic or hemorrhagic cerebral event. SynX is developing a rapid, point-of-care diagnostic test for stroke that would be used in emergency medicine. The patent covers the method of analyzing the levels of proteins released from the brain during a stroke, as detected in a sample of a patient's blood or cerebral spinal fluid.

Philips Medical Systems (Andover, Massachusetts) reported commercial shipment of its Brilliance 40-channel computed tomography (CT) scanner. Philips said the Brilliance 40-channel is the industry's first scanner with detector coverage of 40 mm, reconstruction speed of up to 40 images per second and 40-channel acquisition. The company unveiled a 64-channel upgrade package available to all 40-channel systems at the Journees Francaises de Radiologie congress in Paris. Already in place at several major healthcare facilities worldwide, the Brilliance 40-channel configuration has accumulated information on more than 7,500 patients. The company said the performance boost enabled by the newly introduced 64-channel upgrade option for 40-channel systems will deliver thin-slice acquisition capabilities to the full 40mm width of the Brilliance CT detector by increasing the number of simultaneously acquired data acquisition channels to 64.

Proxima Therapeutics (Alpharetta, Georgia) reported FDA clearance for the next generation of its MammoSite balloon catheter. The latest version of the MammoSite device incorporates enhanced design features, including a thinner catheter shaft and a smaller balloon profile that will provide an even less-invasive means of delivering partial breast irradiation to women with early stage breast cancer. MammoSite, which the company said is the most widely practiced form of partial breast irradiation in the world, enables physicians to deliver radiation therapy from inside the breast over a five-day period. The next-generation MammoSite will be available in 4Q04.

QRS Diagnostic (Plymouth, Minnesota) reported that its technology partner, BP Sure, has received European patent No. 0955873 on its method to detect and measure blood pressure sounds in noisy external environments. The European patent corresponds to U.S. patent No. 5,772,600, and QRS has exclusive worldwide rights to the patented method. The company's BPCard, which it said is the world's first and only computer card blood pressure monitor, uses the patented method to yield precise, digital blood pressure readings in seconds.

Siemens Medical Solutions (Malvern, Pennsylvania) has introduced the Axiom Artis dBA, which it said is the world's first flat-panel, detector-based neurointerventional biplane system. The Artis dBA allows a look at the vascular anatomy of the brain, providing a diagnostic function. However, it also allows for treatment simultaneously, such as in the case of a stroke, where the blockage in the brain vessel can be removed. "From the Artis BA to the dBA, what has changed is we are replacing the image intensifiers which turn X-ray into light and then the light is picked up by the TV camera, into a direct digital system which is the flat detector," said Tom Treusdell, product manager. With the Artis BA, the image intensifiers are like "large round drums sitting on the system," he said. But with the new Artis dBA, now they're flat and "small like a pizza box." Because less radiation can be used no matter how much one magnifies with the system, there is less radiation exposure both to the patient and to the operator, Treusdell said. Siemens also said its Angiography and X-ray Division has introduced Interventional Cardiac 3D (IC3D) technology to create 3-D images of the coronary vessels in the heart. When paired with an Axiom Artis imaging system from Siemens, IC3D allows cardiologists to view the coronaries in 3-D with as few as two images, leading to precision in determining appropriate stent size and length, faster examination times, the use of less contrast medium and lower radiation dosages.

Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of the Endobutton CL BTB Fixation System for use in reconstruction of the anterior cruciate ligament (ACL) in the knee. ACL reconstruction using the Endobutton system restores stability by using a bone-tendon-bone (BTB) graft, which is harvested from the patient's own patella tendon with bone plugs at each end. The Endobutton fixation device holds the graft in place. Surgeons who use the Endobutton CL BTB Fixation System say it provides a stronger repair than previous procedures for ACL reconstruction, and allows them to adjust the length of the graft, depending on the patient's size, according to the company. The system also eliminates the need for a screw at the femoral end, in many cases.

Stellar International (London, Ontario) reported that it has received approval from Health Canada to market Matritech's (Newton, Massachusetts) NMP22 BladderChek, a proteomics-based diagnostic test for the diagnosis and monitoring of bladder cancer. NMP22 BladderChek is complementary to Stellar's Uracyst, GAG-replenishment therapy, which is also prescribed by urologists for the treatment of interstitial cystitis.

St. Jude Medical (St. Paul, Minnesota) reported the first European implant of its new SJM Tailor Annuloplasty Band for use in heart valve repair procedures. The implant was performed by Professor Hans-Joachim Schafers, MD, at the University of Saarland (Homburg/Saar, Germany), on a 57-year-old woman suffering from mitral valve endocarditis. Schafers said the patient is doing well and the device is performing as expected. The SJM Tailor Band, which was launched in the U.S. in July, is a flexible band that accommodates the natural movement of the mitral valve annulus. It can be used in both mitral and tricuspid heart valve repair procedures.

Tm Bioscience (Toronto) reported the launch of its newest Tag-It Mutation Detection Kit, the Ashkenazi Jewish Panel (AJP), a single genetic test that combines mutation detection for eight disease states into one assay. The Tag-It Mutation Detection Kit-AJP provides simultaneous detection of 30 different mutations associated with eight diseases in a multiplex format. The results of detecting mutations in one, several or all eight genes associated with these diseases are provided in an easy-to-read report.

TriPath Imaging (Burlington, North Carolina) said it has submitted new clinical data to the FDA to seek expanded claims for the FocalPoint Slide Profiler to include approval of the FocalPoint GS Imaging System. In a supplemental filing to its premarket approval for the FocalPoint Slide Profiler, TriPath submitted data from a prospective, multi-site clinical study designed to evaluate FocalPoint GS Imaging System-assisted screening of its SurePath liquid-based Pap test. The FocalPoint GS Imaging System is designed to perform automated primary cervical cytology screening and analysis to distinguish between normal and abnormal Pap smears.

Toshiba America Medical Systems (Tustin, California) reported the release of its new Version 5.5 software for the Aplio, the company's premium diagnostic ultrasound system. The new Version 5.5 software features Toshiba's Differential Tissue Harmonics Imaging Option that offers increased spatial resolution and penetration for superior border and tissue definition using enhanced transducers. It also features the new Quick Scan Option that streamlines image optimization for increased productivity and reproducible exams with less inter-operator variability. The Aplio is equipped with next-generation tissue Doppler and contrast imaging technology based on Toshiba's Intelligent Component Architecture to allow faster processing of more complex data, producing improved image quality and sensitivity.

Vasamed (Minneapolis) reported receiving FDA 510(k) clearance for its new SensiLase PAD 3000 Skin Perfusion Pressure system, calling it the first fully automated, commercial system for non-invasive quantitative evaluation of microcirculatory perfusion. The SensiLase is a PC-based diagnostic instrument designed to critical information about the health of the patient's micro circulatory system.

Vascular Solutions (Minneapolis) reported receiving FDA 510(k) clearance for the Langston dual lumen pigtail catheter. The two-lumen diagnostic catheter is indicated for use in the simultaneous measurement of pressures from two locations in the arterial system. The company said the Langston catheter offers simultaneous accuracy and precise responsiveness in measuring intra-arterial pressure gradients.

VisiJet (Irvine, California) reported receiving FDA approval for its EpiLift System, a next-generation, ophthalmic surgical device designed for separating corneal tissue. The EpiLift System is the cornerstone of a new improvement in LASIK surgery called Epi-LASIK, which combines LASIK and PRK refractive techniques. It produces virtually instant visual results like LASIK but with the stable long-term visual outcomes of PRK. The company said a key attribute of the EpiLift System is its ability to cleanly and safely separate the epithelium from the next layer of corneal tissue, Bowman's membrane. In traditional LASIK, a microkeratome creates a permanent flap onto the center layer of the cornea. By eliminating the cutting of stromal flaps, the EpiLift System eliminates the primary cause of LASIK complications, the company said.

Welch Allyn (Skaneateles Falls, New York) reported the introduction of Smartlink Wireless, a rapid response system for transmitting critical patient data from an ambulance or helicopter to a receiving hospital's cardiac care team using a digital cellular network. The Smartlink Wireless system uses a Welch Allyn PIC 50 device that emergency medical services personnel (EMS) use to monitor, and if necessary defibrillate, a patient suffering from a heart attack. Once the EMS team has stabilized the patient for transport to a medical facility, they acquire and transmit a 12-lead electrocardiogram from the PIC 50 to a receiving hospital server using a handheld personal digital assistant (PDA). The receiving hospital server can then send the data to individual clinicians using web-enabled PDAs or telephones.

Zimmer Holdings (Warsaw, Indiana) reported that it has launched what it called the orthopedics industry's first high-flexion design unicompartmental knee for patients who require partial knee replacement and who are capable of attaining high degrees of flexion. The Unicompartmental High Flex Knee completes the offering of high-flexion designs across Zimmer's knee replacement portfolio, and was designed specifically for less-invasive surgeries.