Mechanical valves and tissue valves have always been tough competitors, both providing valuable, life-saving solutions for those with defective heart valves, but both having clear drawbacks.

Mechanical valves are longer lasting but their use then requires a life-long drug regimen, and the concomitant management requirements and possible adverse side effects. Tissue valves wear out and may need replacement, and the sector is still searching for a product that can be implanted in young people and grow with them, rather than needing repeated replacements.

Start-up firm ValveXchange (Aurora, Colorado) hopes to combine the benefits of both, while avoiding the drawbacks of both, with a combination approach. This hybrid offers the potential for offering large positive clinical positives for those needing valve repair and repolacement and the possibility of doing very much better what the two standard-of-caretechnologies already do.

Underline potential.

Still only at the benchtop-testing stage, the valve - invented by Ivan Vesely, PhD, and licensed from the Clinical Clinic Foundation — is a sort of razor/razor blade concept involving implantation of a "docking station" into which can be placed, and then later replaced if need be, the tissue valve leaflets.

This combination thus allows for easy replacement of the tissue portion of the valves, when needed, and no follow-on regimen of drugs is required since the non-tissue docking station is not susceptible to the sheer forces that require anti-coagulation therapy.

The ValvXchange concept offers "the best of both worlds," according to Larry Blankenship, company CEO, who presented the company's technology during a Product Showcase competition at the BioWest 2007 conference in Denver in early December.

Before his presentation, he told Cardiovascular Device Update that the valve system's bovine pericardial leaflets are "a shameless copy" of the well-established Perimount tissue valve from Edwards Lifesciences (Irvine, California), which is no longer patent-protected.

Edwards, the largest maker of tissue valves, would be one of the major players that the ValveXchange valve would threaten. Similarly, the valve could take large market share from St. Jude Medical (St. Paul, Minnesota), a major maker of mechanical valves, since the docking station part of the system does not require the anti-coagulation follow-on regimen. That therapy is required only to deal with the sheer-stresses of mechanical valve leaflet movement, not the docking station of the ValvXchange valve, according to Blankenship.

And in their Showcase presentation, ValvXchange executives noted that the tissue valve change-out can be done in a less-invasive manner, through the chest wall in under 30 seconds on a beating heart.

Another advantage of the technology: as a "me-too" valve, it would be automatically reimbursable, Blankenship told CDU.

ValvXchange has received three $200,000 SBIR grants from the National Institutes of Health, expects a Phase II grant of $1.6 million for follow-on development and was taking advantage of the Showcase opportunity to seek venture funding to take it through the various development and regulatory stages.

Blankenship laid out a clear regulatory timeline that the company hopes will take it to global sales by 2012, noting a variety of points along this timeline for potential exits. (Blankenship noted that the company has already been contacted by some interested buyers, while not disclosing any names.)

ValvXchange competed against five other start-up firms in the Product Showcase competition, winning the award as best new product and walking away with a $10,000 prize.

Elewhere in the product pipeline:

• ATS Medical (Minneapolis) last month reported that 47 patients have now undergone aortic valve replacement with its sutureless ATS 3 Fr Enable aortic bioprosthesis at seven investigative sites in Europe within both the feasibility and pivotal clinical trial phases. Currently, eight patients have surpassed the two-year implant duration. The ATS 3f is designed to eliminate the traditional suturing required to replace a patient's diseased aortic heart valve. If suturing can be eliminated from the procedure, surgeons can potentially reduce procedure time and offer less invasive options for the treatment of aortic valve disease. In addition, the elimination of suturing offers the potential to significantly improve valve related hemodynamics by allowing the surgeon to provide a replacement valve of a size larger than what is traditionally possible with conventionally sutured heart valves. ATS makes cardiac surgery products.
  ATS in December also reported FDA approval of its Open Pivot AP360 mechanical heart valve. ATS said that the AP360 valve "combines hemodynamic performance with a supra-annular cuff design that facilitates implantation. The original ATS Open Pivot promoted hemodynamic performance, enhanced resistance to blood clot formation and improved patient quality of life through quieter valve operation... . the ATS AP360 combines proven performance with a cuff design that extends its appeal to a broader spectrum of surgeons." Michael Dale, president/CEO of ATS said: "Heart valve sewing cuff material and design contribute to the ease with which suturing needles pass through the cuff and an uncomplicated positioning of the valve at the implant site. Surgeons develop a feel for, and gain confidence and comfort in, a cuff that is well suited to their individual surgical techniques."
• Berlin Heart (Berlin) reported the first patient enrollment in the prospective IDE study for its Excor Pediatric VAD, a mechanical cardiac support system for critically ill Pediatric patients suffering from severe heart failure. The multi-center IDE study is to evaluate the safety and probable benefit of using the Excor Pediatric VAD to support Pediatric patients. Excor Pediatric has been designed as a bridge to transplantation for patients waiting for a suitable donor heart, but has also been used as a bridge to recovery when a patient's heart was able to recover and work on its own again. Unlike standard heart-lung machines, Excor Pediatric has been used as a medium- to long-term support system, supporting failing hearts for up to several months. Berlin Heart makes pumps, cannulas, and external components for internal and external use to stabilize cardiac activity in acutely ill patients.
• Biosense Webster (Diamond Bar, California) reported availability of its Cartosound Image Integration module with the new Soundstar 3-D catheter that can be used with the Carto XP Navigation System. The Cartosound module integrates real time intracardiac echocardiography (ICE) images from the Siemens AcusonSequoia and Cypress ultrasound systems using the Soundstar 3-D catheter with the Carto XP EP Navigation System. The ultrasound catheter uses an embedded position sensor to display location and beam orientation on the Carto XP system, Biosense said, which enhances visualization of ICE images and ablation catheter location. According to the company, using the Cartosound module with the Soundstar 3-D catheter in conjunction with the Cartomerge Image Integration module combines the anatomic details of a pre-acquired CT or MRI image with real time ICE. Biosense, a Johnson & Johnson (New Brunswick, New Jersey) company, is a provider of diagnostic, therapeutic, and mapping tools.
• Cook Medical (New York) today reported the launch of its 36mm diameter Cook Zenith Renu AAA ancillary graft. The graft is designed for secondary endovascular intervention in patients who received prior endovascular repair of infrarenal abdominal aortic aneurysms (AAAs). With a wider diameter, the graft enables physicians to treat patients with larger proximal necks who previously may not have been candidates for secondary endovascular repair. The graft is specifically intended to treat AAA patients whose implanted stent-grafts may have shifted. This migration can result in leakage of blood into the aneurysmal sac, ultimately placing the patient at increased risk of aneurysm rupture. The wider diameter graft is available in both the main body extension and converter. The graft has been engineered to treat migrations in either Dacron or ePTFE membrane-based aortic endografts. Cook is focused on makaikng interventional devices.
• EarlySense (Ramat-Gan, Israel) said it has received FDA clearance for its ES-16 system. The ES-16 system, cleared by the FDA, monitors heart and respiratory rates in both children and adults. The technology developed by EarlySense uses a contact-free sensor, meaning that it is not physically connected to the body of the patient. The ES-16 System eliminates patient discomfort and enables the cost-effective monitoring of patients in settings such as homes, hospitals and other clinic settings such as long term care facilities. The system is currently being evaluated at several clinical settings on patients suffering from chronic diseases, such as asthma, COPD and CHF, as well as at acute-care facilities, on critical-care patients and patients hospitalized for various medical and post-operative conditions. "Hospitals and other healthcare providers are facing a growing challenge in treating older and sicker patients. Such providers are looking for technological solutions that allow them to increase the quality of care and improve patient safety without adding to already stretched budgets and manpower. We have addressed this need with a smart monitoring solution that facilitates the improvement of patient safety and nursing efficiencies," said EarlySense CEO Avner Halperin. EarlySense intends to start selling its new product, to be named EverOn, in 2008, following a number of beta-site evaluations in both Israel and the U.S. EarlySense makes "smart systems" for monitoring changes in a patient's clinical condition.
• FlowCardia (Sunnyvale, California) reported FDA 510(k) clearance and immediate U.S. launch of the Crosser 14P, Crosser 14S and Crosser 18 CTO Recanalization Catheters. The three peripheral Crosser catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross chronic total occlusions (CTOs) to help restore blood flow to the lower legs. The Crosser is a rapid-exchange catheter delivered over standard .014" and .018" guidewires that utilizes high-frequency vibration to cross CTOs, allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral Crosser catheters were studied in the FlowCardia PATRIOT Trial. PATRIOT principal investigator Jim Joye said, "After completing the clinical trial, we are looking forward to using the Crosser in our daily practice. The device worked well in the upper leg and also proved an excellent primary therapy for crossing the more difficult, below the knee occlusions. This new endovascular line of catheters will help us cross lesions that previously could only be treated with a more invasive open surgery."
• GE Healthcare (Waukesha, Wisconsin) said it now offers improved dose reduction results for both diagnostic cardiac and neuron perfusion CT exams. GE's SnapShot Pulse technology for prospectively gated diagnostic cardiac CT exams has been proven to reduce a patient's radiation exposure by up to 83% and improve image quality, according to GE. The company said its VolumeShuttle technology delivers twice the anatomical coverage (80 mm) with up to 24% less radiation exposure compared to a conventional 40 mm cine perfusion protocol. Both SnapShot and VolumeShuttle are offered on the GE LightSpeed VCT XT configuration, enabled by a real-time scan control architecture intended to ensure precise control of exposure and table position, the company noted. GE also introduced new editions of its Logiq e compact and a new edition of the Logiq Book XP Enhanced compact. According to the company, Logiq Book XP Enhanced is the third major upgrade of the Logiq Book platform. New features include: new LCD technology with higher resolution, improved off-angle viewing for multiple users, increased brightness and clarity. Faster processing on this new system improves boot-up time by 70%, the company noted. Other faster processing improvements include a 30% faster mode transition, such as changing from black-and-white imaging to color Doplar for vascular applications.
• LeMaitre Vascular (Burlington, Massachusetts) reported the commercial launch of the TT Tortuous Tracker Delivery System, the introducer for LeMaitre Vascular's EndoFit and UniFit Aortic Stent Graft product lines. The TT system is designed to simplify stent graft implants by requiring reduced deployment force, providing the physician with increased control over placement of the stent graft in the aorta. The TT system offers flexibility and an improved coating to increase maneuverability through blood vessels and a three-part valve system to minimize blood loss during the medical procedure. The TT system also provides better visualization during the procedure and a more ergonomic design. LeMaitre Vascular makes devices for the treatment of peripheral vascular disease.
• Masimo (Irvine, California) reported the approval of the Masimo Rad-57 pulse co-oximeter, saying that this is "the world's first and only technology capable of noninvasively measuring carbon monoxide (CO) levels in the blood to the Japanese market." The Rad-57 is a fast, accurate and noninvasive way to detect elevated levels of CO in the blood, without having to draw blood and wait for costly lab results. When a clinician places the Masimo Rad-57's sensor on a patient's finger and presses a button, the device will detect the percentage of CO in the bloodstream in just seconds, allowing for prompt and possibly life-saving treatment. In addition, the Masimo Rad-57 measures SpO2, pulse rate and perfusion index with Masimo SET technology. Masimo makes pulse co-oximetry and read-through motion and low perfusion pulse oximetry.
• Medtronic (Minneapolis) reported filing the final module of its premarket application with FDA for its Talent abdominal stent graft system, a minimally-invasive device that treats dangerous bulges in the aorta, a large artery that can rupture without warning. Medtronic said that the Talent has a history of established clinical performance with more than 40,000 implants worldwide. A clinical trial demonstrated that the device met its safety endpoint of superiority in freedom from major adverse events at 30 days, and the aneurysm-related mortality rate at 12 months was 1.8%. The patients receiving the Talent were older and had higher-than-baseline co-morbidities, they had lower rates of death, myocardial infarction, respiratory failure, paraplegia, and blood loss compared with subjects treated with open surgery at 12 months, according to the company. There were no aneurysm ruptures and no conversions to open surgery in the Talent group up to 12 months after implantation. The final module is "a comprehensive clinical data set," said Katie Szyman, VP and general manager of Medtronic's endovascular innovations business. She said that Talent "will expand treatment options for patients with abdominal aortic aneurysms and provide a strong complement to our market-leading AneuRx AAAdvantage stent graft."
• PLC Systems (Franklin, Massachusetts) reported that it has discussed the results of its pilot safety study of the RenalGuard system and therapy with the FDA. Based upon the positive safety data already collected in the pilot study and its discussions with FDA, PLC has stopped enrolling new patients in the pilot study and will submit a request to transition into a new pivotal trial protocol. The trial is expected to demonstrate that RenalGuard is effective in reducing the incidence of contrast-induced nephropathy (CIN) in at-risk patients undergoing cardiovascular imaging procedures. PLC Systems specializes in technologies for the cardiac and vascular markets.
• SonoSite (Bothell, Washington), reported the introduction of the S-Cath visualization tool, a specialized ultrasound device designed to meet the specific point-of-care imaging and procedural guidance needs of cardiologists and interventional radiologists. Its available suite of curved, linear and phased array transducers cover a range of guidance for interventional procedures such as line placement, biopsy, dialysis access, stent placement, femoral and other vascular access and fluid drainage as well as abdominal and cardiovascular imaging applications. With standard VESA-compliant mounting capabilities, the system offers a zero footprint option for crowded interventionalist suites and cath labs. It can be mounted adjacent to other imaging modalities and moved in and out of the physician's line of sight as needed. SonoSite makes hand-carried ultrasound devices.
• The Sorin Group (Milan, Italy) reported the first commercial implant of the Mitroflow aortic pericardial heart valve in the U.S. Introduced in Europe in 1982, the Mitroflow valve underlines the company's experience with bovine pericardium, from tissue harvesting to proprietary design solutions and high technology processes. Because the pericardium is mounted on the outside of the stent, it allows for maximum valve opening and optimum blood flow. The Mitroflow bioprosthesis offers surgeons the option, based on patient anatomy, of a supra-annular or an intra-annular valve placement designed to reduce the risk of patient-prosthesis mismatch and enhance hemodynamic performance. The sewing cuff design has shown that the valve is easy to suture, conformable to the native annulus and adaptable to difficult anatomies.
• SPO Medical (New York) has introduced the PulseOx 6000 and PulseOx 6100. The PulseOx 6000 (finger device) and PulseOx 6100 (hand-held device) both have been designed for use by medical professionals, hospitals and managed care facilities. Both devices use reflective pulse oximetry (RPO) technology for accurate and reliable measurements of blood oxygen saturation and heart rate, and include the SPO Medical new AutoSpot technology for patients suffering low perfusion. SPO Medical makes biosensor and microprocessor technologies for use in portable monitoring devices.
• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its Epic stented tissue valve with Linx AC technology. Identical in design to the company's Biocor valve the Epic valve also uses anti-calcification technology designed to protect against tissue mineralization, or hardening. The Epic valve features a low overall valve height, enhancing implantability. In the mitral position, the valve's low profile reduces the risk of obstructing blood flow into the aorta. In the aortic position, it may provide optimal coronary ostia clearance and reduce the risk of aortic wall protrusion. The new valve will be available in aortic, aortic supra and mitral models. Valve durability is affected by both mechanical stress and tissue calcification. The Epic is designed to address both issues to deliver long-term performance. St. Jude Medical makes cardiac, neurological and chronic pain devices.
• SunTech Medical (Morrisville, North Carolina) reported the release of the SunTech 247 diagnostic station. The company said the device "bridges the gap in price and capability between manual blood pressure gauges and vital signs monitors." It is available in the U.S. exclusively through IMCO and NDC members and worldwide through SunTech authorized distributors. The SunTech 247's modular design allows the addition of temperature and SpO2 modules and is available in a variety of mounting configurations, including wall, table or mobile stand. SunTech Medical makes blood pressure technology equipment.
• Textronics (Wilmington, Delaware) reported the introduction of a new transmitter for use with the stretchy fabric electrode sensors that are knit into the company's NuMetrex brand of heart rate monitor fitness apparel. The new transmitter snaps into a tiny pocket in NuMetrex sports bras and shirts, where it receives the heart rate signal from textile sensors located across the chest band area. The data is then transmitted to a watch or exercise machine that displays a read-out of the heart rate. Textronics makes wearable sensors for fitness and health monitoring.
• Theregen (San Francisco) reported completing enrollment in its 15-patient Phase I safety trial for the Anginera epicardial patch on patients undergoing coronary arterial bypass graft surgery. The company said it intends to treat patients suffering from cardiac dysfunction who are undergoing surgery for a variety of reasons, including CAD and ischemia, heart valve disease or septal defects. In each of these populations, a portion of the heart is beating poorly, and Anginera has demonstrated an ability to improve both perfusion and regional ventricular wall function. In patients with ischemia and prior myocardial infarction or heart attack, this treatment may limit the area of heart muscle damage by providing better local perfusion. It may also awaken "hibernating myocardium" to improve ventricular wall function, and may not only improve function in the short term, but may prevent the progressive deterioration of function that leads to increasing heart failure. Theregen said it is "re-purposing" an existing FDA-approved device for cardiac applications.