Edwards Lifesciences (Irvine, California) reported in late November that it has developed a new ap-proach 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 to perform trans-apical 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.

Shortly after it reported the new approach, Edwards said it had received conditional FDA approval to restart a trial it had suspended in mid-June for the minimally invasive procedure to replace the aortic valve. The suspension of the trial came after the company received reports of complications, including death, among some of the roughly 10 patients enrolled in its U.S. clinical trial. The conditional approval – the primary condition being institutional review board approval – will allow the company to enroll 20 patients in a non-randomized feasibility trial of the Cribier-Edwards percutaneous aortic heart valve, which also will incorporate a larger valve size of 26 mm to allow for what it termed “more optimal sizing” and to treat a broader range of patients.

In reporting the new TAP approach, Stuart Foster, corporate vice president of technology and discovery at Edwards, said the technique offers the company “another access route to implant that valve.” He told Cardiovascular Device Update that the new surgical approach is one that will be worked on in tandem with the company’s minimally invasive percutaneous procedure, 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. “This is about providing more options and parallel passing,” Foster said.

Piper Jaffray (Minneapolis) analyst Thomas Gunderson said that one approach doesn’t necessarily supplant the other. “I can see these going in parallel,” he told Reuters. “The percutaneous [approach] is a fascinating yet embryonic area where you would move more toward the catheter specialty of the interventional cardiologist, so you would have a completely separate customer base,” he added.

The halted/restarted trial represents a speed bump for Edwards toward the development of a percutaneous valve replacement technology that represents a brand-new sector in cardiovascular therapy since currently only the open surgical approach is available to such patients. In contrast to repair via open surgery, percutaneous heart valve replacement can be performed under local anesthesia without opening the chest or stopping the heart. In this strategy, the device is threaded through the patient’s circulatory system via catheter to the aortic valve from either one of two directions, antegrade and retrograde.

The antegrade approach involves crossing the patient’s septum and mitral valve to reach the native aortic valve. The retrograde approach involves delivering the device directly to the aortic valve through the patient’s main artery. The restarted trial will take place at three clinical sites and feature use of a new protocol, a retrograde delivery approach, in addition to incorporating the larger-sized replacement valve.

The antegrade approach, the company said, was marked by a greater degree of clinical complexity and the reported adverse outcomes, when compared to a Canadian study, where cases were being performed with the new retrograde delivery approach. The company said it believes the retrograde delivery provides a simpler route for introducing the valve non-surgically than the antegrade approach that was used in its U.S. feasibility trial.

Elsewhere in the product pipeline:

• Aldagen (Durham, North Carolina) said that researchers from the Washington University School of Medicine (St. Louis) presented results at the American Society of Hematology meeting in Atlanta demonstrating that the human adult stem cell population isolated by Aldagen’s products (ALDHbr cells) are able to regenerate vascular function in a pre-clinical model of ischemic injury. To test the neoangiogenic function of ALDHbr cells in vivo, the researchers performed femoral artery ligation in the hind limb of NOD/SCID B2M null mice, and transplanted purified ALDHbr cells from human bone marrow via the tail vein within 24 hours of ischemic injury. The recovery from acute ischemic injury was calculated by the ratio of blood flow in the ischemic vs. the non-ischemic leg by laser Doppler perfusion imaging, performed twice weekly over 28 days. In comparison to PBS-injected control mice, mice transplanted with ALDHbr cells showed enhanced blood flow to the ischemic limb by day seven post-injection. This enhanced recovery of blood flow was maintained throughout the 28-day monitoring period.

• 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.

• Cook (Bloomington, Indiana) said it is launching the Advance ATB PTA Dilatation Catheter, a new percutaneous transluminal angioplasty balloon catheter, with advanced features never before offered by Cook. For optimized performance, the new Advance balloon design has been optimized for ease of insertion and pullback into the sheath. Responding to the needs of physicians performing numerous dilatation procedures, the Advance balloon incorporates an increased lumen size for faster inflation/deflation rates while still providing sufficient rated burst pressure to dilate demanding lesions. Cook’s Ultra-Push shaft creates a strong axial force for enhanced trackability without added stiffness. The balloon’s short, tapered tip allows dilatation in confined spaces and increases accessibility within strictured vascular anatomy. In addition, the Advance balloon maintains constant diameter throughout its working range of pressures. Embedded gold radiopaque markers on the catheter shaft facilitate precise positioning under fluoroscopy. The world’s largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK is a manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and Ob/Gyn, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.

• Impulse Dynamics USA (Orangeburg, New York) said that Newark Beth Israel Medical Center (Newark, New Jersey) is enrolling patients in a clinical study to investigate the safety and effectiveness of its new implantable pulse generator, the Optimizer. The Optimizer System is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure. The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is designed to investigate the effects of the Optimizer System in about 400 New York Heart Association Class III or Class IV heart failure patients at up to 50 U.S. sites. Impulse Dynamics, the sponsor of the study, is a wholly owned subsidiary of Impulse Dynamics NV (Tirat Hacarmal, Israel), the device developer and manufacturer.

• 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.

• 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. Medtronic Vascular (Santa Rosa, California) spokesperson Scott Papillon told CDU 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 currently already has an approval in the U.S. for an AAA device with its AneuRX device.

• Medwave (Danvers, Massachusetts), a developer of sensor-based, non-invasive blood pressure measuring solutions, said it has submitted a 510(k) application to the FDA for its Primo Non-Invasive Blood Pressure Monitoring System. In conjunction with researchers and clinicians at Massachusetts General Hospital (Boston), Medwave has completed clinical validation studies for the Primo system, testing its performance against that of an invasive arterial catheter.

• MIV Therapeutics (Vancouver, British Columbia), a developer of next-generation biocompatible coatings and advanced drug delivery systems, reported favorable results demonstrated by preclinical studies of its Aortic Embolic Protection Device (AEPD) designed to prevent strokes and other serious complications that can result from cardiac procedures and other causes. Once implanted in the aorta, the AEPD functions as a deflector and filter to prevent migration of embolic particles and blood clots that can obstruct or block blood vessels supplying the brain. The study was designed to measure the device’s safety and to confirm critical positioning and performance following implantation in the aorta. The results of the study performed on sheep under varying conditions are considered medically significant, and reinforce the device’s potential as a viable preventive tool to fight strokes in cardiac patients, the company said.

• 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.

• St. Jude Medical (St. Paul, Minnesota) reported FDA approval and market release of the IBI-1500T6 Cardiac Ablation Generator and Therapy electrophysiology catheters. The high-power IBI-1500T6 Cardiac Ablation Generator, delivering up to 100 watts of radio frequency power, is a microprocessor-controlled instrument offering a user-friendly platform for programming all procedure-related settings. During a procedure, the 1500T6 monitors all critical performance variables. Temperature and impedance from the catheter tip electrode are updated continuously to offer maximum user control. Sophisticated signal filtering, which eliminates unwanted frequencies, results in continuous intracardiac electrogram recording during monitoring and ablation modes, St. Jude said.

• SurModics (Eden Prairie, Minnesota), a pro-vider of surface modification and drug delivery technologies to the healthcare industry, said that its advanced hydrophilic technology has been licensed to Medtronic (Minneapolis) to provide the lubricious coating on the delivery system of Medtronic’s Endeavor drug-eluting coronary stent. “Deliverability is a key differentiator in the stent market, and we believe the combination of Medtronic’s stent technology and SurModics’ hydrophilic coating technology helps achieve this objective with outstanding results,” said Bruce Barclay, president and CEO of SurModics.

• Vascular Solutions (Minneapolis) reported that it has received 510(k) clearance from the FDA to launch the Twin-Pass dual access catheter. The Twin-Pass is a two-lumen catheter designed to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature and for use during procedures using two guidewires. The company said it expects to launch the Twin-Pass catheter through its direct U.S. sales force in January. Vascular Solutions also reported that it has begun the launch of the V3 version of the Pronto extraction catheter in the U.S. through is direct sales force and in Europe through its independent distributor network. The V3 improvements include a full-length wire braid and hydrophilic coating for ease of deliverability and enhanced performance. The Pronto V3 catheter is designed for the mechanical aspiration removal of acute thrombus from the arterial system.

• 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.