After more than a year-long delay following FDA panel turndown, a new treatment for lumbar spinal stenosis (LSS) finally received an approval from the agency. St. Francis Medical Technologies (Alameda, California) reported in late November receiving FDA approval of its premarket application (PMA) for its X Stop interspinous process decompression (IPD) system to alleviate the symptoms of LSS, a common spinal problem suffered mainly by the middle-aged and elderly population and often associated with debilitating pain in the back and legs.

By a 5-3 vote in late-summer 2004, the Orthopedic Rehabilitation Devices Panel of the FDA’s Medical Devices Advisory Committee voted against recommending approval of the X Stop system, even though many panel members praised the device’s “innovative design.” While the system had achieved its primary effectiveness endpoint, the panel members were apparently not convinced by the study data. And though they said they thought it was safe, they focused on discrepancies in trial data.

In some ways, the delay ended up being a good thing for the company, said Kevin Sidow, president of St. Francis Medical. “We felt like we took advantage of the delay,” he told Biomedical Business & Technology. “Certainly the awareness of the product in our situation has grown since the turndown 15 months ago, and I think we’re in a much better position to take this to surgeons and have them make this part of their practice.”

The system has been approved for sale in Europe and Japan since 2001 and has been successfully implanted in more than 4,000 patients, according to the company. St. Francis, founded in 1997, has billed the IPD system as a “middle-of-the-road measure” between non-surgical treatment and a much more invasive lumbar laminectomy.

A laminectomy relieves pressure on the spinal cord or spinal nerve by widening the spinal canal via removal or trimming of the lamina – or roof – of the vertebrae to create more space. The procedure also may involve fusing vertebrae or removing part of a disc.

“Unlike laminectomy, the X Stop procedure does not require general anesthesia, making it a more viable option for those with lumbar spinal stenosis who cannot tolerate general anesthesia as a result of their age or other health conditions,” said James Zucherman, MD, co-inventor of the X Stop and medical director of St. Mary’s Spine Center (San Francisco). “This new procedure fills a gap in the continuum of care that, until now, required patients to make the leap from conservative therapies, such as analgesics and injections, straight to invasive surgery.”

The small, two-piece, non-fusion titanium device is inserted through a small incision while the patient is on his or her right side in a fetal-like position. Since the X-Stop is placed outside the spinal canal, no bone or soft tissue must be removed. The procedure requires only local anesthesia and takes less than an hour.

Compared to laminectomy, which is a permanent procedure, the X Stop can be removed at any time.

Elsewhere in the product pipeline:

• The first patient in the U.S. in a 15-patient Phase I safety trial of the SEPET artificial liver support device being developed by Arbios (Los Angeles) was enrolled last month at Albert Einstein Medical Center (Philadelphia). Einstein is one of two institutions in the country selected to participate in the trial, which is designed to assess the safety and efficacy of the technology. The clinical trial also will evaluate the device’s potential as a blood purifier to provide temporary liver support during acute-on-top-of-chronic liver failure and facilitate recovery from liver failure, support liver regeneration and help keep liver failure patients alive until an organ becomes available for transplantation. Walter Ogier, president and CEO of Arbios, said the public company, which was founded in 2000 by two surgeons at Cedar Sinai Medical Center (Los Angeles), is developing technology to regenerate the liver as well as to serve as a bridge to transplant. The SEPET device represents the company’s attempt to deal with the former issue. “It involves the principle of separating out harmful substances from the blood of patients who were experiencing acute liver disease and acute liver failure,” Ogier said. He said that the principle of operation for the device is similar to that of a dialysis machine in that it employs a size exclusion membrane across which harmful substances pass and are filtered from the bloodstream. The SEPET device is designed for use with a standard hemofiltration system, but uses a cartridge containing hollow fibers with unique permeability characteristics. When a patient’s blood is pumped through these fibers, the blood is cleansed of impurities and toxins that accumulate in liver failure. Unlike dialysis, a repetitive and painful process, Ogier said this therapy is used only for a period of a few days at a time and also has a membrane designed to remove larger molecules that pass through it.

• BioMimetic Therapeutics (Franklin, Tennessee), a manufacturer of recombinant protein-based products for the treatment of orthopedic and sports injury indications, said it has received FDA approval for its lead product, GEM 21S. The first BioMimetic product to be PMA-approved by the FDA, GEM 21S is a fully synthetic regeneration system for the treatment of periodontal bone defects and associated gingival recession. GEM 21S is composed of the tissue growth factor, recombinant human Platelet-Derived Growth Factor, and a synthetic bone matrix, Beta-tricalcium phosphate. It is the first totally synthetic product combining a purified recombinant growth factor with a synthetic bone matrix to be approved by the FDA for human application, the company said.

• BioniCare Medical Technologies (Sparks, Maryland), which develops non-invasive devices for the regeneration of musculoskeletal soft tissues, reported data from a Phase IV trial of its patented pulsed electrical stimulator, the BioniCare Knee Device, that confirm the device’s safety and efficacy in managing and treating symptoms associated with osteoarthritis (OA) of the knee. The prospective, open-label study, which began in November 2003, involved 288 OA patients from 58 centers in the U.S. who had experienced an inadequate response to, or were intolerant of, therapy with nonsteroidal, anti-inflammatory medications (NSAIDs) and/or analgesics. Patients wore the BioniCare Knee Device for an average of six to 10 hours each day and were asked to report any adverse events experienced while using the device. Data showed that all patients experienced an increase in the effects of the BioniCare Knee Device on primary endpoints compared to baseline reports. Patients who reported using the device for more than 750 hours experienced 50% or more improvement in one or more outcome areas than those who used the device for less than 750 hours. In addition, 45.4% of NSAID users reduced their use by 50% or more and 18% of NSAID patients discontinued use altogether.

• Boston Scientific (Natick, Pennsylvania) said it has received approval from the FDA to begin a prospective, randomized, double-blind pivotal trial to evaluate the safety and efficacy of occipital nerve stimulation as a treatment for refractory migraine headache. The study, known as PRISM (PRecision Implantable Stimulator for Migraine), will use Boston Sci’s Precision neurostimulator and involve about 150 patients at up to 15 sites in the U.S. The company said the Precision device is the smallest rechargeable neurostimulator on the market today and already is approved by the FDA for spinal cord stimulation to treat chronic pain. In the PRISM study, the neurostimulator will be used to deliver electrical impulses to the occipital nerves located just under the skin at the back of the neck. Occipital nerve stimulation is intended to treat migraine headache in patients who do not respond to other therapies. Boston Scientific said there are more than 28 million migraine sufferers in the U.S. and up to 10% of these patients may not respond to existing treatments.

• CABG Medical (Minneapolis) reported the completion of enrollment in the first arm of its international clinical trial of the Holly Graft System, a drug-eluting graft for facilitating a coronary artery bypass procedure. “Our initial results do not meet the standards necessary to obtain regulatory product approvals allowing distribution of the Holly Graft System to the general population of bypass patients,” said Chairman and CEO Manny Villafana. “We hope to improve our clinical results in the second phase of our clinical evaluation. Our intention at the conclusion of this second phase of clinical trials is to gather the data on the two anti-coagulation regimens to assess their relative efficacy as a treatment modality for Holly Graft implantations. We will also seek to make such product improvements as are deemed necessary to arrive at an optimal graft design for all bypass patients.”

• CHF Solutions (Brooklyn Park, Minnesota) reported that data from two studies published in the Dec. 6 edition of the Journal of the American College of Cardiology show that Aquapheresis, the company’s advanced ultrafiltration procedure, is a safe and effective means to remove large volumes of excess fluid in congestive heart failure patients with fluid overload. In addition, the studies demonstrated improved patient outcomes after Aquapheresis therapy both in the hospital and sustained for three months, when compared to diuretic drug therapy alone. The RAPID study was a multicenter, randomized controlled trial with 40 patients among six hospitals that compared outcomes from a single eight-hour session of ultrafiltration vs. 24 hours of diuretic treatment. The data showed that ultrafiltration is well-tolerated and associated with effective volume removal, relief of symptoms, improved hemodynamics, increased responsiveness to subsequent diuretic therapy, and increased sodium excretion, despite decreasing doses of diuretics. The single-center, prospective EUPHORIA trial included 20 patients and explored whether ultrafiltration could result in earlier balance of body fluids and earlier discharge from the hospital. The EUPHORIA study documents that early ultrafiltration safely and effectively reduces congestion in acute decompensated heart failure patients with diuretic resistance.

• Conceptus (San Carlos, California), maker of the Essure Permanent Birth Control system designed to provide a non-incisional alternative to tubal ligation, said more than a dozen scientific presentations at the American Association of Gynecologic Laparoscopists meeting in Chicago covered topics such as hysteroscopic sterilization under local anesthesia and long-term safety and efficiency of the Essure system. The Essure Permanent Birth Control system achieves tubal sterilization through hysteroscopic placement of micro-inserts in the fallopian tubes. The presentations discussed success rates of initial placement and permanent occlusion of the Essure device, pain scores and procedure satisfaction ratings. The data also indicates that offering the Essure procedure in the office setting is convenient and cost effective for both patients and physicians. The company said the meeting confirms hysteroscopic sterilization can successfully be performed in an office setting with minimal anesthesia using the Essure procedure, giving both gynecologists and their patients a safe choice in permanent birth control.

• Cytyc (Marlborough, Massachusetts) reported that 13 studies evaluating the performance of its NovaSure System for endometrial ablation were presented at the American Association of Gynecologic Laparoscopists meeting in Chicago. Among them: long-term results demonstrating excellent efficacy and safety rates for the NovaSure System were presented by Tamas Fulop, MD, of St. Imre Teaching Hospital (Budapest, Hungary), who concluded that at seven-year follow-up, “Hysterectomy due to menorrhagia was avoided in 100% of cases and in 92% of cases for all other reasons.”

• Drager Medical (Luebeck, Germany) said its SmartCare/PS option for the EvitaXL ventilator has received 510(k) market clearance from the FDA and is available for sale in the U.S. SmartCare is a knowledge-based ventilation system developed to improve the efficiency and effectiveness of the weaning process by integrating protocolized care into ventilation weaning. SmartCare automates the weaning process, based on the user’s input, using continuously measured parameters and patient respiratory profiles. As the level of ventilator support is adjusted automatically, the patient’s response and ability to adapt to each change in support is evaluated. In addition, by reducing weaning time, the company said SmartCare may lower the risk of complications such as ventilator-associated pneumonia and lung injury, leading to reductions in the cost of care, improved resource utilization, and decreased incidence of ventilator morbidity.

• Edwards Lifesciences (Irvine, California), which still is awaiting clearance from the FDA to resume an early-stage clinical trial for its minimally invasive procedure to replace the aortic valve, reported that it has developed a new approach for placing a valve in a beating heart. A medical team from St. Paul’s Hospital (Vancouver, British Columbia) used Edwards’ Cribier-Edwards percutaneous heart valve – the same one being evaluated in the minimally invasive procedure – to perform transapical placement (TAP), a beating-heart procedure in which a sutureless, stent-mounted aortic valve was delivered through a mini-incision between the ribs using the company’s Ascendra aortic valve replacement system, developed specifically for this new procedure. The new technique is intended to reduce recovery time and complications associated with open-heart surgery, which requires opening the patient’s chest and stopping the heart. Stuart Foster, corporate vice president of technology and discovery at Edwards, said this new technique offers the company “another access route to implant that valve.” He said that the new surgical approach is one that will be worked on in tandem with the company’s minimally invasive percutaneous procedure, which has been in limbo since Edwards postponed a trial for it in the U.S., and is not meant to replace that program. According to Foster, the new technique is simply meant to provide surgeons with more options and evolved as an outgrowth of the company’s work on percutaneous valve replacement.

• FzioMed (San Luis Obispo, California) reported the publication of positive results from a U.S. clinical trial of Oxiplex/AP for adhesion prevention in laparoscopic gynecological surgery. The article was published in the November issue of Fertility and Sterility Journal. The trial was designed to study the safety and preliminary effectiveness of Oxiplex/AP as an adhesion prevention device for women undergoing conservative gynecological surgery by laparoscopy. The company said the results of the study demonstrated that Oxiplex/AP was safe, easy to apply and provided clinically significant, site-specific reduction in adhesion formation when applied to adnexal surfaces.

• Glucon (Boulder, Colorado) reported recent trial results of its flagship product, Aprise, a continuous, non-invasive, glucose monitoring device. The data was presented by Dr. Benny Pesach, vice president of research and development, during the Diabetes Technology Meeting in San Francisco. Pesach said three different protocols were employed to test Aprise. In the first protocol, rapid glucose variations were induced by venous infusion of dextrose solution and insulin. In the second protocol, the glucose level was increased by drinking a glucose solution and decreased by the diabetic subject’s regular medications. In the third protocol, the glucose level was raised with a regular meal and decreased again by the diabetic subject’s regular medications. Thirty subjects participated in the studies. Glucon also reported that it has secured an option to license several photoacoustic technology patents, granted to a group of scientists at the University of Texas Medical Branch (Galveston, Texas).

• I-Flow (Lake Forest, California) said its ON-Q Post-Operative Pain Relief System was featured in five presentations at the American Society of Anesthesiologists (ASA; Park Ridge, Illinois) annual meeting in Atlanta. The company said the studies bring the total number of presented or published ON-Q studies to more than 50, and underscore the role of ON-Q in helping patients to return to normal more quickly following surgery. All of the studies presented at ASA highlighted the safety and efficacy of the use of surgical site post-operative pain relief technology, with data spanning a variety of surgical categories, including gynecologic, orthopedic, urologic and pediatric. Don Earhart, CEO of I-Flow, said, “Our continued support of clinical research enables I-Flow and researchers to demonstrate the role and need for ON-Q in more surgeries and patient populations . . . as this therapy moves toward replacing narcotics as a standard of care.”

• Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) said that Schering AG (Berlin, Germany) has completed the evaluation of its new fluorescence dyes with three modified CT Laser Mammography (CTLM) systems from IDSI. Imaging Diagnostic Systems said it believes that fluorescence dyes and other vasoactive agents may help improve the cancer detection accuracy of laser breast imaging and that it will continue research in this area. The CTLM system uses laser technology and algorithms to create 3-D cross-sectional images of the breast.

• Karl Storz Endoscopy-America (Culver City, California), a provider of endoscopy and medical video imaging systems, said it has launched its latest addition to the Image 1 camera platform for endoscopic surgery. The new, fully digital DCI - D1 (Direct Coupled Interface) Camera Head offers a compact design within the Image 1 platform, which the company said facilitates standardization throughout the operating room. It can be directly coupled securely to existing Karl Storz DCI Video Intubation Systems and Video Macintosh blades for Anesthesia, as well as Lerut Video Mediastinoscopes in Thoracoscopy. The DCI - D1 Camera Head can be fitted to most standard-eyepiece telescopes by using convenient adapters. The company said the DCI - D1Camera Head provides several advantages during endoscopy procedures, including its DCI coupling mechanism that allows easy assembly and enhanced interchangeability of endoscopes within the sterile field. In addition, reprogrammable easy-access buttons on the camera head provide intuitive sterile field access to all camera functions.

• Kensey Nash (Exton, Pennsylvania) said it has completed enrollment in the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) study for its new TriActiv FX System. ASPIRE is a multi-center, prospective registry, designed to support regulatory clearance of the TriActiv FX System in the U.S. for a saphenous vein graft indication. The company said it expects to submit a 510(k) application to the FDA within 90 days. The TriActiv System incorporates a protection balloon guidewire that creates a protected space, a flush catheter that washes the graft, and an automated extraction system that removes the debris found in the graft. These three features work in combination to prevent the debris, found in the graft, from embolizing and potentially causing a heart attack.

• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) has introduc-ed an enhanced HIV Screening Assay to identify individuals with primary HIV infection. Primary or acute HIV infection is that period following recent infection when an individual has not yet developed detectable levels of HIV antibodies. During this window period, infected individuals are considered significant contributors to the spread of HIV as they tend to have very high levels of the HIV virus, are very infectious and often are not aware of their HIV status, the company said. LabCorp’s enhanced HIV Screening Assay provides for automatic HIV nucleic acid testing (NAT) on antibody-negative samples utilizing a proprietary pooling method.

• Medtronic (Minneapolis) reported that it has submitted its first pre-market approval (PMA) module to the FDA for its Talent thoracic stent graft system. The stent grafts are used to treat thoracic aneurysms, which are dangerous bulges in the aorta that can rupture without warning. The Talent device has been commercially available in Europe and other areas outside the U.S. since 1999 and used in more than 18,000 procedures. It is the market leader for thoracic stent grafts in Europe. Stent graft therapy is designed to provide a minimally invasive alternative to the more typical conservative medical management often termed “watchful waiting,” with reduced recovery times and potentially improved survival rates. Medtronic Vascular (Santa Rosa, California) spokesperson Scott Papillon said that while the abdominal aortic aneurysm (AAA) opportunity is twice as big as that of the thoracic aneurysm in the endovascular space, “thoracic is still a very big, untreated and unmet need.” The company already has an approval in the U.S. for a AAA device with its AneuRX device. Minimally invasive thoracic aneurysm therapy involves threading a stent graft through a small opening in the femoral artery of the leg. The stent is advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysm or dissection, where it is then deployed. Once placed in the correct location, the stent graft expands to fit within the diameter of the aorta and provides a new path for the blood flow. Medtronic initiated the 338-patient Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial in November 2003 and completed enrollment in June 2005. The pivotal study is evaluating the safety and efficacy of the Talent system, with patients followed for one year.

• Merge eMed (Milwaukee), a Merge Healthcare company and provider of medical imaging software and services, reported the release of Fusion RIS (radiology information system) and RIS/PACS (picture archiving and communication system) Version 3.0. The new enhancements in scheduling, dictation, exam routing, and RIS/PACS hanging protocol configuration produce RIS-driven hanging protocols that capture the power of RIS information to streamline the presentation of images in the PACS, which can be accessed throughout the enterprise from a single, unified end-user desktop application. Fusion RIS is a comprehensive, easy-to-use, HIPAA-supportive RIS designed to replicate radiology workflow “best practices” within imaging centers or radiology departments.

• MIV Therapeutics (Vancouver, British Columbia), a developer of biocompatible coatings and advanced drug delivery systems, reported that a pivotal long-term animal study of its stent coating technology has been concluded, with results that were unequivocally successful in demonstrating the coating’s biocompatibility and safety. The six-month study indicated that the company’s Hydroxyapatite-based coatings were excellent candidates for advanced drug-eluting stent coatings, the company said. In contrast to polymeric stent coatings, “the Hydroxyapatite coating we studied is built entirely of a mineral native to the human body and as such may have a long-term biocompatibility advantage,” said Greg Kaluza, MD, scientific director of the Center for Research in Cardiovascular Interventions of the Methodist Hospital Research Institute, and lead investigator for the study. “Results indicate this coating may be safely used as a drug-eluting platform since it may be expected from the present study that the Hydroxyapatite coating will remain inert in the arterial wall even long after the drug is completely eluted.”

• Northfield Laboratories (Evanston, Illinois) reported that an independent data monitoring committee has recommended that the company’s pivotal Phase III trial with PolyHeme continue without modification following the fourth planned interim analysis of the study data. The committee reviewed blinded data on mortality in the first 500 patients enrolled in the study. According to the company, this is the first time a hemoglobin-based oxygen-carrying resuscitative fluid has successfully passed this patient evaluation milestone in the high-risk trauma population. Northfield’s Phase III study is designed to evaluate the safety and efficacy of PolyHeme when administered to patients in hemorrhagic shock following traumatic injury. It is the first study in the U.S. in which treatment with an oxygen-carrying resuscitative fluid begins at the scene of injury. Patients are currently being enrolled at 24 Level I trauma centers in the U.S., with a planned total enrollment of 720 patients. The primary endpoint is survival at 30 days.

• Novare Surgical Systems (Cupertino, Claifornia) said its EndoLink line of single-use, hand-held surgical instruments is the first to provide surgeons with enhanced anatomical access and device control not available with conventional, straight laparoscopic instruments. The company said the EndoLink instruments allow nearly unlimited surgical access, and may reduce the complexity and shorten the learning curve for laparoscopic surgery of the chest and abdomen. According to Kerry Pope, Novare’s president and CEO, the instruments were used in their first laparoscopic applications in lung lobe removal and a complex gallbladder removal, combined with adhesion removal and colectomy involving extraction of a portion of the colon.

• Restore Medical (St. Paul, Minnesota) said that results of a one-year clinical study of its Pillar palatal implants, the only FDA-cleared implantable device treatment for obstructive sleep apnea (OSA), demonstrate that the Pillar Procedure is a safe and effective first-line treatment for mild-to-moderate OSA, with more than 80% of study participants demonstrating a reduction of their apnea. Clinical highlights of the study, presented at the 109th American Academy of Otololaryngology-Head and Neck Surgery meeting, include that 81% of the patients achieved reductions and nearly 60% achieved resolution of their apnea as measured by their Apnea Hypopnea Index to less than 10 per hour; and that results were better than or comparable to the results reported in studies of Uvulopalatopharyngoplasty (UPPP; a surgical procedure that removes excess tissue at the back of the throat) and were achieved in a low-cost, single-procedure, outpatient office setting, with significantly less pain and morbidity than that experienced with UPPP procedures.

• Stereotaxis (St. Louis), which makes advanced cardiology instrument control systems, reported that the first automated mapping of a patient’s right atrial heart chamber in conjunction with the treatment of a difficult-to-ablate tachyarrhythmia was completed using the company’s Niobe Magnetic Navigation System. The automated mapping feature allowed Warren Jackman, MD, director of clinical electrophysiology at the University of Oklahoma Health Sciences Center (Oklahoma City), to move a magnetically navigated catheter to 49 places in the chamber of a beating heart in about six minutes, all with a touch of a button on the Niobe system, to better define the anatomy of the chamber and more precisely reach the target site to effectively treat the arrhythmia. Stereotaxis said it believes that its Niobe system will be able to improve both the efficiency and efficacy of electrophysiology mapping procedures, while making the time required to perform the procedure more predictable. In addition, it said the consistent “soft-touch” contact with the heart wall unique to magnetically navigated catheters may reduce the risk of perforation, while providing a more accurate map of the patient’s anatomy than can be achieved via manual navigation.

• StructuRad (Encino, California) and SmartPACS (Irvington, New Jersey) reported the availability of StructuRad reporting technology from the SmartPACS PiViewSTAR PACS worklist. The companies said StructuRad’s integration with SmartPACS represents a breakthrough voice and macro-reporting paradigm that makes radiology reporting faster, easier and more accurate. The integrated solution enables radiologists to create structured reports directly from the PiViewSTAR worklist without having to change any workflow or reporting process.

• VirtualScopics (Rochester, New York), a pro-vider of advanced medical image analysis services, said that the company co-authored two studies that were presented at the American College of Rheumatology meeting in San Diego. One study explored VirtualScopics’ bone-cartilage contrast ratio as a quantitative osteoarthritis (OA) biomarker. The results show this biomarker can be used to quantify differences between OA and normal subjects, which could potentially be used in clinical trials for subject selection and/or to monitor the effect of the treatment. And a joint research effort used VirtualScopic’s image analysis tools to eliminate bone marrow edema as a correlated indicator of joint pain. While bone marrow edema is not correlated to pain as shown in this research, there remains the possibility that bone marrow edema is an early indicator of OA, the company said.

• VMT Scientific (Las Vegas) said that its VasCir system has begun development for hand, finger and limb units, as well as the feet. Designed to re-establish microvascularization and tissue histogenesis, the company said the system has the potential to reduce the number of diabetic peripheral vascular disease-related amputations by 50% or more. Preliminary tests indicate that as much as a 300% increase in arterial blood flow to the treated limb in as little as 15 minutes. The company said it is working to obtain FDA approval of the VasCir system and to qualify it for Medicare reimbursement.

• Zargis Medical (Princeton, New Jersey) reported the response from a panel of primary care physicians assembled to evaluate a prototype computer-aided auscultation system. After a review of the prototype system, all seven panelists agreed that it would improve their referral accuracy of patients with heart murmurs. In addition, six members of the panel reported that the prototype system and the results it provided were “very easy to understand and use.” Zargis said input gathered from the panel helps validate its ongoing R&D efforts, which are focused on developing potential enhancements to the Zargis Acoustic Cardioscan (ZAC) system, the company’s existing, FDA-approved device. The company said it may incorporate new features from the prototype evaluated by the physicians into ZAC, pending authorization from the FDA. The new features could be added in time for the commercial introduction of ZAC. Zargis was formed in 2001 when Siemens Corporate Research, a division of Siemens, and Speedus co-invested to develop and market an advanced acoustic technology designed to detect heart abnormalities identified through analysis of heart sounds.