CryoLife’s (Kennesaw, Georgia) decellularized replacement heart valve — used to replace diseased, damaged, malformed or malfunctioning pulmonary valves — in early February received FDA 510(k) clearance. Children who face multiple surgeries for congenital heart defects will likely be the most significant beneficiaries of the new valves, according to the company, by potentially reducing the number of surgeries they must have over a lifetime.

The company said that the CryoValve SG may be available for shipment late this quarter.

Clearance of the SynerGraft valve was based on data comparing 342 SynerGraft valves, implanted between 2000 and 2004, to 1,246 traditional allograft heart valves sold by the company. The data included information on mortality, device-related re-operations, structural valve deterioration, endocarditis (an inflammation of the heart’s inner lining) and blood clots. The FDA found that the SynerGraft valve performed at least as well as traditional allograft valves.

“We believe the CryoValve SynerGraft [SG] pulmonary human heart valve is the first decellularized heart valve on the market,” D. Ashley Lee, CryoLife’s CFO/COO told CD&D. “We essentially remove the cells from the heart valve and you’re left with a collagen matrix. It’s a significant advancement for people with diseased pulmonic valves. Kids born with cardiac defects face a series of surgeries. The SG process will increase the durability of heart valves and reduce the number of those surgeries.”

The decellularized tissue potentially lowers the risk of an immune response and subsequent tissue rejection. The SG valves are also good choices for children because they avoid the need to take blood-thinning medications on a long-term basis and are less likely to calcify than heart valves from a pig or cow.

Lee said there may be other decellularized organs available by other tissue processing companies, but that this is the first heart valve.

The American Heart Association (Dallas) estimates that about 1 million Americans have a congenital heart defect. About 35,000 babies in the U.S. are born with a heart defect each year.

When human tissue is recovered from a cadaver for future implantation, it is typically inspected, cleaned and decontaminated to prevent infection, but the allograft remains otherwise unchanged. CryoLife’s SG technology removes allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. What remains is a scaffold of connective tissue that still functions like a human heart valve, according to the company. “It takes much longer to process these heart valves,” Lee said. “We put them through a series of steps designed to remove the cellular debris, including [using] a series of solutions.”

The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures, commonly performed in children with congenital heart defects. In addition, it can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient’s defective aortic valve is removed and replaced with his own pulmonary valve.

The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.

The FDA issued its own statement about the clearance on Friday, an action generally reserved for products that it considers as significant advancements. “Today’s clearance is a promising advance in allograft products,” said Daniel Schultz, MD, director of FDA’s Center for Devices and Radiological Health. “FDA welcomes innovations in manufacturing that provide more medical options for patients.”

Elsewhere in the product pipeline:

• Abiomed (Danvers, Massachusetts) said that it has developed a new portable circulatory support driver for both in-hospital and out-of-hospital patients. The portable driver is designed to support Abiomed’s AB5000 ventricular assist device. The combination of the new driver and the company’s FDA-approved AB5000 VAD provides support of acute heart failure patients. The AB5000 can assume the pumping function of a patient’s failing heart, allowing the heart to rest, heal and potentially recover. AB5000 is designed to provide either uni-ventricular or bi-ventricular support. Abiomed’s portable driver is a bi-ventricular system that delivers the pressures and vacuums equivalent to Abiomed’s AB5000 console and its iPulse console. Testing showed that the portable driver is capable of providing full support for a year’s intended use. The unit is expected to require low maintenance, approximately every 5,000 hours of operation. Abiomed’s AB5000 has FDA approvals for all acute heart failure indications.

• AtriCure (West Chester, Ohio) reported that the first patient was successfully treated in AtriCure’s ABLATE clinical trial. The purpose of the ABLATE clinical trial is to evaluate the safety and effectiveness of AtriCure’s Isolator Synergy bipolar ablation system for reestablishing normal heart rhythm in patients with permanent atrial fibrillation (AF), requiring concomitant open-heart surgery using the Cox Maze IV procedure. The Isolator Synergy bipolar ablation system is designed to create precise lesions, or scars, on heart muscle, which block irregular electrical signals and restore normal sinus rhythm. AtriCure specializes in cardiac surgical ablation products.

• Cambridge Heart (Bedford, Massachusettss) reported the publication of a proposed decision memorandum regarding Medicare coverage of Microvolt T-wave Alternans (MTWA) diagnostic testing. The Centers for Medicare & Medicaid Services maintained coverage of MTWA using the spectral analysis method and found insufficient evidence for coverage of MTWA using any other method. Cambridge heart said that the proposed decision memorandum is the result of a CMS six-month evaluation of the relevant clinical evidence available to the agency and consideration of public comments submitted on the request to expand coverage to include the Modified Moving Average (MMA) methodology. The memorandum proposes to continue the existing coverage of MTWA with spectral analysis. CMS issued a National Coverage Determination on March 21, 2006 that provides Medicare coverage for MTWA, only when the spectral analytic method is used. CMS has opened a 30-day public comment period and has requested commentary on the proposed decision memorandum, including perspective on the reported findings of the MASTER Trial and its impact on MTWA coverage. Cambridge Heart intends to submit comments supporting the proposed decision and highlighting the limitations of the MASTER trial, as well as the overwhelming body of clinical evidence which supports the use of the analytic spectral method to identify patients at risk of SCD. The final National Coverage Determination is anticipated on or before May 14, 2008.

• Cardica (Redwood City, California) reported the launch of its new C-Port xA X-Change Distal Anastomosis System, now commercially available in the U.S. The C-Port is a cartridge-based, reloadable C-Port system, that allows surgeons to attach multiple blood vessel grafts using the same handle during a coronary artery bypass graft (CABG) procedure. The C-Port accommodates cartridges pre-loaded with staples, allowing a surgeon to complete multiple anastomoses using the same CO2-powered handle. Each device in the C-Port system product line is designed to enable automated, reliable and reproducible connections of blood vessels during cardiac bypass surgery. Unlike most hand-sewn anastomoses, Cardica’s C-Port systems create compliant anastomoses that can expand and contract with blood flow. In addition, the C-Port anastomosis systems, whether used during on- or off-pump surgery, offer surgeons unique access to a wide range of coronary arteries, particularly small coronary arteries, which, in the past, have been difficult or impossible to connect effectively. Cardica makes automated anastomosis systems for CABG surgery.

• CeloNova BioSciences (Newnan, Georgia) reported results from the Atlanta study of the Catania Coronary Stent System with NanoThin Polyzene-F at the 20th Annual International Symposium on Endovascular Therapy (ISET). Features of the Catania includes: early and complete vessel healing, as early as 30 days; patients can discontinue dual anti-platelet therapy after only one month; protection from stent thrombosis; and the Polyzene-F surface treatment is bacterial-resistant. CeloNova BioSciences specializes in products using their material, Polyzene-F.

• Cook Medical (Bloomington, Indiana) reported enrollment of the first patient in the STABLE clinical trial used to evaluate the company’s Zenith Dissection Endovascular System for the treatment of Type B thoracic aortic dissections. Cook said FDA approval to begin the three-center U.S. Phase I trial was granted last fall. The company says that the device is the “first of its kind” and designed specifically to treat aortic dissection. The Dissection Endovascular System looks a bit like a thin-wire slinky, covered in a cloth-like mesh. It is intended for use in the endovascular treatment of descending thoracic aortic dissection, the company providing the qualification that it is used only “in patients with anatomies appropriate for endovascular repair.” Physicians insert a catheter loaded with the self-expanding stent-graft (called the TX2) through a surgical opening in the femoral artery. The catheter is then guided through the patient’s blood vessels under fluoroscopy until the device is positioned across the weakened section of the aorta. The stent-graft expands upon deployment from the catheter to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel, restoring normal blood flow. The uncovered Zenith Dissection Stent may be used to expand the true lumen in the distal thoracic aorta where preservation of the side branch artery blood flow is critical. The TX2 Stent Graft repairs the primary entry tear while the bare metal dissection stents were placed to expand and support the remainder of the dissected aorta for the length of the dissection (in this case to the level of the aortic bifurcation). The company said that it hopes for completion of Phase I STABLE within six months, hopefully garnering FDA approval by 2010.

• CryoCor (San Diego), focused on the treatment of cardiac arrhythmias, reported today the publication of a European study of atrial fibrillation (AF) patients treated with its Cardiac Cryoablation System to evaluate the role of atrial flutter (AFl) in the recurrence of AF and the effectiveness of an ablation strategy focused on isolating the pulmonary veins to treat the AF. The study was published in the Dec. 11, 2007, issue of Circulation. The study prospectively evaluated the best catheter ablation strategy in patients with paroxysmal AF with and without concomitant right AFl. During follow-up averaging 26 months, the authors found that electrical isolation of the pulmonary veins by catheter ablation was successful in patients without concomitant AFl at an 82% success rate. In patients with concomitant AFl, the combination of ablation for AFL and pulmonary vein isolation alone to treat AF was frequently insufficient in preventing recurrences of AF (recurrence rate of 67%). The authors concluded that those patients with AFl and AF may require additional sites of ablation to effectively treat their atrial fibrillation. Luz-Maria Rodriguez, MD, senior author of the study, said, “This is the first time that an ablation strategy for paroxysmal atrial fibrillation and atrial flutter has been systematically studied. This has implications for the tools that a clinician may use to treat these atrial arrhythmias. Based on this study, we do not believe that it will be sufficient to simply isolate the pulmonary veins in a significant proportion of patients.”

• eCardio Diagnostics (The Woodlands, Texas) said it will release several new product features and services at the Boston Atrial Fibrillation Symposium, an international meeting of cardiology specialists. Among eCardio’s new product releases is the addition of eTimer automatic data capture feature to its cardiac event monitor, the eTrigger AF 920. This allows for the capture and monitoring of ECG data at pre-defined and programmable intervals throughout the patient’s cardiac monitoring protocol. To complement the company’s client and information services, it is launching its eSignature information technology services program. In this service offering, eCardio partners with clients to develop and implement unique and specialized medical and clinical data management packages to facilitate the workflow, efficiency and operation of academic departments and cardiology practices.

• Escalon Medical (Wayne, Pennsylvania) reported that its Sonomed subsidiary has received FDA clearance for the Master-VU ophthalmic B-scan ultrasound system. The system consists of a B-scan probe that can be interfaced to a standard personal computer (via a USB cable connection) using Sonomed’s software, thereby converting the personal computer into an ophthalmic ultrasound system. The Master-VU features include: measurement calipers for multiple intraocular measurements; the ability to save both 30-second “clips” as well as individual frames on a scrolling frame manager; and on-screen annotation capability, including text and graphics. Sonomed is a diagnostic ultrasound company specializing in the design, manufacture and distribution of instruments for ophthalmology. Escalon makes ophthalmic diagnostic, surgical and pharmaceutical products as well as vascular access devices.

• Global Med Technologies (Denver) reported FDA clearance for ElDorado Donor -- a new blood management product produced by its Wyndgate Technologies division. The ElDorado Donor is intended as a comprehensive blood management software application created to provide for the information system needs of blood bank and donor centers. The software is designed to manage, automate, and control activities associated with donors, donor collections, testing, manufacturing, inventory, and distribution. ElDorado Donor was developed with scalability in mind and is designed to manage the system needs of diverse facilities, from small hospital blood banks to community blood centers, to regional and national centers. Using an integrated modular configuration, ElDorado Donor is intended to offer functionality with flexibility to tailor features within the system to a facility’s specific needs supporting process control from collection to distribution. Global Med Technologies is an e-health medical information technology company.

• Innocoll (Ashburn, Virginia) said that the first of two Phase III clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx Gentamicin Surgical Implant for the prevention of surgical site infections, has commenced dosing. The implant is a biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll’s proprietary collagen-based drug delivery technology, CollaRx, and (outside of the US) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. The cardiac surgery trial will enroll diabetic and/or obese (BMI>30) patients known to be at a higher risk of sternal wound infections, a serious and potentially life-threatening complication of cardiac surgery.

• Medtronic (Minneapolis) reported the U.S. market launch of the AneuRx AAAdvantage stent graft on the new Xcelerant hydro delivery system, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. In addition, Medtronic received FDA approval to introduce its latest generation of packaging materials for the launch of this product. The Xcelerant system will be used with the AneuRx AAAdvantage stent graft. The Xcelerant features an integrated sheath that is tapered on both ends. This dual-taper sheath is designed to facilitate insertion and retraction of the entire delivery catheter by minimizing the time that the surface area of the sheath is in contact with the artery wall. The integrated sheath also contributes to the system’s low profile characteristics, which are intended to enable excellent tracking and access through small vessels.

• Orqis Medical (Lake Forest, California) said that the company’s MOMENTUM Trial Abstract was accepted for Late Breaking Clinical Trial presentation at the upcoming (March) annual meeting of the American College of Cardiology (Bethesda, Maryland) in Chicago, March 29-April 1. MOMENTUM evaluated the percutaneous Cancion System in patients with acute decompensated heart failure. Barry Greenberg, MD, who will present the abstract, termed MOMENTUM “a landmark study examining the hemodynamic and clinical effects of the Cancion System in managing patients hospitalized with heart failure inadequately responsive to medical therapy.” Orgis makes products for treatment of heart failure.

• The first fully automated ablation system supporting an open-loop irrigated catheter using remote navigation with the Niobe magnetic navigation system, designed by Stereotaxis (St. Louis) and the Carto RMT system by Biosense Webster (Diamond Bar, California), has received FDA approval. The system uses the Navistar RMT Thermocool Irrigated Tip Catheter and the Coolflow Pump from Biosense Webster, with the Stockert RF Generator. The catheter incorporates small irrigation holes at the tip to provide cooling during RF ablation. The addition of the Niobe magnetic system and the Carto RMT system provides electrophysiologists with accurate 3-D mapping, targeting and remote navigation the companies said. Biosense Webster, a Johnson & Johnson company, makes diagnostic navigation and mapping tools. Stereotaxis makes cardiology instrument control system for use in a hospital’s interventional surgical suite.

• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance for its EnSite Fusion Registration Module, new software to help physicians create detailed heart models to facilitate the diagnosis and delivery of therapy for complex abnormal atrial heart rhythms, including atrial fibrillation. EnSite Fusion software registers, or integrates, an EnSite System-created chamber model with a three-dimensional computed tomography (CT) model so that the physician has an improved view of the heart’s anatomy to better guide the delivery of therapy. EnSite Fusion has the capability for “dynamic registration,” which allows for adjustments fusing the EnSite System-created and CT-derived models, giving physicians a more detailed image of the heart. Dynamic registration allows physicians to adjust the EnSite System-created model at key anatomic locations to more precisely adapt to the 3D, CT model.

An independent investigator clinical trial has shown atrial fibrillation (AF) is effectively treated using the Epicor Cardiac Ablation System, when treated concomitantly to corrective heart surgery. The results were published in The Annals of Thoracic Surgery. St. Jude Medical (St. Paul, Minnesota) makes the Epicor system. The investigators reported that more than 83% of all patients, followed for at least six months after surgery, were free from AF. In surgical ablation performed with a high-intensity focused ultrasound (HIFU) energy source, energy is focused from outside a beating heart to create precise and complete lines of cardiac tissue ablation to block chaotic electrical impulses. The patient does not need to be placed on a heart-lung bypass machine nor is the heart stopped. The HIFU ablation device used in the study, the Epicor Cardiac Ablation System, has received FDA clearance for the surgical ablation of cardiac tissue.

• ThromboVision (Houston) said that it has initiated clinical trials of its ThromboGuide (T-Guide) platelet function monitor. The T-Guide consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients’ lives by individualizing antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions. ThromboVision has licensed the patented technology developed by scientists affiliated with the Utah Artificial Heart Institute, Brigham Young University and the University of Utah. ThromboVision develops biomedical diagnostics.

• Toshiba America Medical Systems (TTAMS; Tustin, California) reported FDA clearance for its new open-bore 1.5T vantage titan MR system. The company said the open-bore of the titan is 18% larger than other 1.5T systems on the market, featuring a large 71-cm patient aperture. The system features Toshiba’s Pianissimo noise reduction technology, designed to create better imaging. The titan also uses Toshiba’s contrast-free MRA techniques – fresh blood imaging, contrast-free improved angiography, time-spatial labeling inversion pulse, and time-slip angiography. TAMS makes magnetic resonance technology.

• Valor Medical (San Diego) said that it has received approval for the first clinical trial in Europe for Neucrylate, a liquid injected into a cerebral aneurysm through a micro-catheter placed from the femoral artery. When Neucrylate comes in contact with blood, the liquid changes into a solid material similar to a sponge. The surgical procedure for injecting Neucrylate will take less time, yet offers a more complete filling of the aneurysm as compared to coiling. Valor is an emerging company that has developed an injectable device for the treatment of cerebral aneurysms.

• Vasomedical (Westbury, New York) reported receiving a U.S. patent for technology that automatically controls and maintains the inflation and deflation pressures within the cuffs during enhanced external counterpulsation (EECP) therapy. The company said that the patent also provides for a method to automatically release all applied pressure to the atmosphere in the event of a system or power failure as a safety measure to avoid injury to the patient. At the start of treatment, the therapist selects the optimal inflation pressure for the patient to comfortably receive effective therapy; the technology then fully controls and maintains, with accuracy, the proper inflation and deflation pressures throughout the treatment. EECP therapy is a noninvasive, outpatient therapy used to manage chronic stable angina and heart failure.

• Volcano (San Diego) reported FDA clearance of the s5-Revo and s5-FFR (fractional flow reserve) options. These two new product offerings now enable rotational IVUS and FFR to operate on the same integrated Volcano s5 imaging system as Volcano’s previous line of phased array IVUS catheters and functionality. For the first time, physicians can choose among three diagnostic tools on the same integrated IVUS platform. Earlier generation consoles included only one of the three technologies now available on the s5. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. Volcano said that the s5 can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple digital IVUS, and pressure-based FFR guidewires) on a single platform. Volcano specializes in intravascular ultrasound and functional measurement technology.