Medically speaking, this may be — borrowing a line from poet Robert Frost — "the road less traveled." This particular road is the human esophagus, and the traveler is the Hickey Cardiac Monitoring System (HCMS), being developed by emerging med-tech company Scivanta Medical (Spring Lake, New Jersey).

The goal of the journey: to provide the primary measurements of cardiac performance in a less-invasive and more cost-effective manner.

David LaVance, CEO of Scivanta, told Cardiovascular Device Update that its HCMS technology, rather than acquiring cardiac measurement data by invading an artery, capitalizes on the "unique anatomical relationship of the esophagus and the left atrium," because "the esophagus runs just in front of the spine between the spine and the heart."

Scivanta licensed the technology, LaVance said, in November from the University of Buffalo (Buffalo, New York) where Donald Hickey, MD, spent 12 years developing it.

Though LaVance noted that while Scivanta has been around for more than two decades as a medical device distributor, it headed down the broader path to product development about three years ago with the focus to acquire and develop technologies with advantages over existing procedures and treatments.

The HCMS is a minimally-invasive cardiac monitoring device using an esophageal two-balloon catheter that provides cardiac performance data similar to that obtained through pulmonary artery catheters (PACs), such as the Swan-Ganz catheter. According to the company, the device addresses many of the shortcomings of PACs, by bringing minimally-invasive cardiac monitoring technology to intensive care units and to cardiology, surgical and anesthesia markets — with the minimally invasive route because very much more traveled in medicine these days.

Because Swan-Ganz and other PACs must be inserted through an artery by a trained physician, the use of these devices is limited to critical care settings, Scivanta says.

In addition to the usual risks associated with cardiac catheterization, such as infection and pneumothorax (compressed lung), studies have suggested that patients undergoing monitoring with PACs have significantly greater mortality during hospitalization due to the invasive nature of these procedures.

According to Scivanta, there is a "considerable lack of consensus on how to use the readouts from a Swan-Ganz catheter and which relevant clinical parameters the device actually measures."

With the HCMS, once the caregiver positions the catheter, the balloons are inflated. Wall motion in the left atrium and aorta generates pressure changes in the respective balloons. The electronic monitoring system connected to the catheter records signals from these pressure changes as well as data from an electrocardiogram (ECG), phonocardiogram, and automated blood pressure cuff. The monitoring system then translates the raw data into relevant, real-time clinical measurements, the company said.

Although the catheter can be inserted through the patients' mouth and down the throat, LaVance said it would most likely be inserted through the nose, similar to a nasogastric (NG) tube, which is passed through the nose and down the esophagus into the stomach. Because no surgery is required, a physician, nurse or medical technician can do the insertion.

LaVance said Scivanta is still in the development-stage with its HCMS, estimating launch of clinical trials in about nine months.

The HCMS is Scivanta's first product, but LaVance said the company is looking for other technologies that meet its acquisition criteria: technologies that have progressed through the development stage and where very little, if any, research on the product or technology remains.

Scivanta in April received the final payment of $2.55 million from Syntho Pharmaceuticals (Farmingdale, New York) and its principal owner, Muhammed Malik (collectively, the Synthro Group), related to a settlement entered into among Scivanta, the Synthro Group and other related parties on Nov.22, 2006. LaVance said the funds will be used for working capital purposes and to support development of the HCMS.

Scivanta is hoping to stand apart from other companies in the cardiac monitoring sector with the HCMS technology, and LaVance guessed the market for this product to be as large, or larger, than the Swan-Ganz market, which he estimated at about $200 million.

Scivanta said it believes that taking a less-invasive route with its cardiac monitoring system will result in the device being used in applications outside of surgical and intensive care settings. Perhaps that will make — as Frost might say — "all the difference" for this emerging med-tech company.

Elsewhere in the product pipeline:

• Abiomed (Danvers, Massachusetts) reported completing enrollment of 20 patients in its pilot clinical trial of the Impella 2.5 circulatory support system. High-risk angioplasty is defined as patients undergoing angioplasty on an unprotected left main coronary artery lesion, or the last patent coronary conduit, and poor cardiac function. The MACH 2 study looked at patients who were admitted for an AMI with hemodynamic instability, had the necessary procedure to re-open the blocked artery, and then received the Impella 2.5 or standard care including intra-aortic balloon-pump for a few days. The preliminary results showed that patients supported by the Impella 2.5 technology had significantly improved cardiac function at three days and at four months after the heart attack as compared to a control. These results also showed an increase in ejection fraction of 9% and 13% at three days and at four months, respectively, in the Impella 2.5 group as compared to 2% and 5% in the control.

• AngioDynamics (Queensbury, New York) reported that it will launch the NeverTouch VenaCure procedure kit for laser treatment of severe varicose veins. The product will use a proprietary laser fiber technology designed to provide an enhanced level of perforation protection by further preventing contact between the fiber tip and the vessel wall during treatment. AngioDynamics makes devices for the minimally invasive treatment of cancer and peripheral vascular disease.

• ATS Medical (Minneapolis) reported submitting its request to the FDA for review of an Investigational Device Exemption for its 3f Enable Aortic Bioprosthesis. The ATS 3f Enable Aortic Bioprosthesis is the company's second tissue valve product to market. The company calls it a "first of its kind prosthesis" designed to eliminate the time-consuming procedure of placing and tying the 12-20 or more sutures necessary to implant current valve replacements. A flexible Nitinol frame has been integrated with the companies' initial tissue valve offering, the ATS 3f Aortic Bioprosthesis. During an open chest procedure and after removal of the diseased valve, the ATS 3f Enable Aortic Bioprosthesis is folded into a reduced geometry and diameter that is positioned in the native valve annulus with a proprietary delivery system. Upon deployment, the Nitinol frame and valve expand within the annulus applying a continuous radial force that effectively implants the valvewithout the need for sutures. Overall procedure time and specifically, cardio-pulmonary bypass time can be significantly reduced.

• Biological Signal Processing (BSP) has received FDA approval for the new version of its system HyperQ Stress System, a PC-based ECG system providing diagnosis of ischemic heart diseases. The improvements include an updated user interface and improved algorithms for noise reduction that increase diagnostics accuracy. The company said it also will be capable of producing a diagnosis rather than just readings. The new version of the device is being tested in a pilot scheme with Maccabi Health Services. Biological Signal Processing makes non-invasive products for the diagnosis and monitoring of ischemic heart diseases.

• Boston Scientific (Natick, Massachusetts) reported the launch of enrollment in its matrix and platinum science (MAPS) clinical trial designed to investigate relevant endpoints for evaluating the efficacy and durability of endovascular treatment of brain aneurysms. The trial's primary endpoint is target aneurysm recurrence, which is a composite endpoint comprised of target aneurysm re-intervention, target aneurysm rupture or re-rupture or death. Patients will be randomized to receive either Matrix2 detachable coils or GDC detachable coils. Boston Scientific makes GDC coils, a bare-platinum detachable coil cleared for aneurysm treatment, as well as Matrix2 coils, which are covered with a polyglycolic- polylactic acid bio-polymer.

• Cook Medical (Bloomington, Indiana) reported that a study that examines the times in which Cook's Günther Tulip vena cava filter could be successfully retrieved from patients has presented what it called "breakthrough" results. It said that clinical data revealed that the filter can be safely retrieved up to 12 weeks post-implant with a success rate of 94% when used for prevention of pulmonary embolism. The Günther Tulip is an implanted device used to capture blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. Cook Medical produces numerous medical devices.

• Endologix (Irvine, California) reported receiving FDA approval to manufacture the ePTFE graft material used in the Powerlink system for the minimally invasive treatment of abdominal aortic aneurysm (AAA). Specifically, ePTFE is the graft material that covers the Powerlink system's self-expanding cobalt chromium alloy stent cage. The company's self-manufactured ePTFE graft material meets the same product specifications as that currently in use in Powerlink System production. Endologix makes minimally invasive treatments for vascular diseases.

• FoxHollow Technologies (Redwood City, California) reported launch of the SilverHawk SXL, part of its product line which includes 10 different sizes of minimally invasive catheters designed to remove atherosclerotic tissue that blocks leg arteries in patients suffering from peripheral artery disease. The SilverHawk has a lengthened nosecone that features 150 micron laser-drilled vent holes in the tip of the catheter. The tiny vent holes help to release fluid during tissue collection. When combined with the longer nosecone, this new technology may allow for increased tissue collection capacity. FoxHollow makes endovascular therapeutic devices for the treatment of peripheral artery disease.

• MIV Therapeutics (Atlanta) reported the addition of a portfolio of new cardiovascular stents and related products, which have already received CE-marking for commercialization in several multibillion dollar markets, including Europe, Asia and India. The new products include the GenX CrCo thin-strut coronary stent system, which was recently combined with MIVT's biocompatible stent coatings in a milestone bench test showing that together, the technologies pass critical FDA fatigue test guidelines. Other products acquired by MIVT include the GenX stainless steel coronary stent system, the X-ACT Inflation Device, a haemostatic y-connector adaptor kit, an insertion tool, a guide wire torquer and a high-pressure 3-way stopcock. MIVT makes biocompatible coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices.

• Possis Medical (Minneapolis) reported that its AngioJet Spiroflex VG rapid exchange catheter has been approved by FDA for blood clot removal in coronary conduits. The catheter was first introduced to remove thrombus in larger peripheral arteries, and the recent approval allows the catheter to be used in saphenous vein bypass grafts in the heart and larger native coronary vessels. The catheter offers performance benefits, including: increased trackability inside the vessel; improved crossing in difficult anatomy; and 360-degree thrombus removal. Possis makes products for endovascular procedures.

• Signalife (Greenville, South Carolina) reported the development of software that can provide objective evaluation of electrocardiograph performance, including its Fidelity 100 ECG system. Presently, the objective evaluation of different ECG recorders is performed by parallel recordings of the device under test and the control device. In the case of differences between the two, it is difficult to determine which device recorded the source signal with higher fidelity. A combination of the Signalife simulator and newly developed proprietary software will allow the objective comparison of different electrocardiograph devices. Signalife is a life sciences company focused on the monitoring and detection of disease through continuous biomedical signal monitoring.

• St. Jude Medical (St. Paul, Minnesota) reported winning FDA approval of its Merlin.net Patient Care Network (PCN), an Internet-based central repository for patient device data intended to enable physicians and clinicians to connect directly to their patients' stored device data remotely through a secure web site. Merlin.net PCN is designed to collect data from implant procedures, remote transmissions and in-clinic follow-up sessions. With immediate access to patient information through the Merlin.net PCN web site, physicians can monitor and assess patient device data and determine the level of care needed remotely, according to St. Jude. Patients can send data directly to physicians using Merlin.net PCN from theirown home via the Housecall Plus portable transmitter. Merlin.net PCN supports all currently marketed Atlas and Epic family implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) device families in the U.S., the company noted. The Merlin.net PCN is also a centralized storage system that allows data to be sent directly to a clinic's or hospital's electronic health records (EHR) system, St. Jude said. The ability to transfer device data from Merlin.net PCN to an EHR system, where a patient's comprehensive medical history is stored, may enhance patient safety by providing physicians with all pertinent medical information in one location to aid their decision making, the company added.

• Stereotaxis (St. Louis) reported that its partnered, magnetically-enabled 8 mm ablation catheter has received FDA approval and will soon be commercially available in the U.S. The 8 mm catheter expands electrophysiology applications for the Stereotaxis magnetic navigation system by providing physicians the ability to deliver high power ablations for the treatment of atrial arrhythmias. Atrial flutter, a common atrial arrhythmia estimated to represent 25% of the more than 400,000 ablation procedures performed worldwide each year, is routinely treated with 8 mm catheters. Stereotaxis makes cardiology instrument control systems for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias.

• SynCardia Systems (Tucson, Arizona), reports the availability for clinical investigation of a portable driver, the Companion, that is designed to allow stable U.S. patients to recover at home while they wait for their donor heart for transplant. For OR and ICU applications, the Companion is designed to be docked into a hospital cart that features a 15" monitor intended to be viewed from across a room. For stable patients to be discharged, the Companion is designed to be "re-docked" into a smaller caddy that features large wheels and an adjustable handle intended to facilitate patient mobility. SynCardia makes the only FDA- and CE Mark-approved temporary total artificial heart.

• Thoratec (Pleasanton, California) reported that the FDA approved an Investigational Device Exemption supplement allowing it to enroll up to an additional 60 patients in the Bridge-to-Transplantation (BTT) arm of its HeartMate II Phase II trial under a Continued Access Protocol (CAP). The company said that this was the third CAP it has received for this trial, and that it also recently received CAP approval for the Destination Therapy (DT) arm of the trial. The original trial design for the BTT arm called for enrollment of 133 patients. As of April 27, the company reported enrollment of 296 patients in the BTT arm. The original DT trial design called for enrollment of 200 randomized patients. As of April 27, it said that 188 patients had been enrolled in the randomized arm of the trial. The CAP patients will be enrolled and followed under the original protocol of the pivotal trial. The addition of these patients will not impact the timing for the company's planned submission of a PreMarket Approval Amendment seeking FDA approval of the HeartMate II for the BTT indication. The HeartMate II is a continuous flow device designed to provide long-term cardiac support. An implantable LVAS (Left Ventricular Assist System) powered by a rotary pumping mechanism, the HeartMate II is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part.

• Zoll Medical (Chelmsford, Massachusetts), reported release of a new model of its AutoPulse Non-Invasive Cardiac Support Pump, which can document, store and upload device and patient data. The capability allows uploading of information from as many as four patients to Zoll RescueNet code review or CodeNet software via an infrared communications port on the AutoPulse. The AutoPulse data is combined with manual CPR data, defibrillator and other resuscitation data in what the company calls a "user-friendly" code summary format that can document virtually all CPR and resuscitation efforts over an entire event. Quality measures, such as CPR compression depth, rate and interruptions, as well as all AutoPulse use data, are all reviewed. Zoll Medical makes resuscitation devices and related software solutions.