CD&Ds

For many years, the standard treatment for infrarenal abdominal aortic aneurisms (AAA) has been open surgery. An investigational stent system from Vascutek (Glasgow, Scotland) will enable a minimally invasive treatment.

A surgeon from Arizona Heart Institute (Phoenix) in June performed the first procedure in the U.S. Anaconda Phase II Study using the Vascutek Anaconda Stent Graft System.

AAAs are a ballooning of the body's main artery and can cause sudden death. Even with open surgery, there's a 25% to 50% risk of death. The minimally invasive approach uses stent grafts and has been associated with a decreased risk of death, faster recovery, minimal blood loss and shorter hospital stays.

"The advantage of this graft is that even after you deploy it, you can relocate and reposition it," Julio Rodriguez, MD, vascular surgeon at the Arizona Heart Institute and Arizona Heart Hospital, and the study's principal investigator, told Cardiovascular Devices & Drugs. "The danger is that if you deploy too low or too high, you compromise flow to the kidney. So, technically speaking that's [Vascutek's Anaconda Stent Graft System] a real advantage. It's also very flexible and allows you to use them in a very tough anatomy."

Although the stent system is being tested in the U.S. for FDA approval, plenty of data already are available, with nearly 4,000 patients having been treated in Europe.

"Experience with the device has been very positive," said Donald Reid, MD, chairman of vascular surgery at Wishaw General Hospital and University of Glasgow (both Glasgow), who attended the procedure at Arizona Heart Hospital.

The Vascutek Anaconda Stent Graft System has magnetic wire technology to ease the deployment of the contralateral leg. A dual proximal ring stent design with four pairs of nitinol hooks provides a seal with positive fixation as security against stent graft migration. Radiopaque markers aid with the device placement. The graft system is constructed from woven polyester fabric.

Rodriguez said the first procedure was performed on June 8 on a relatively healthy man in his late 50s who required only a single night's stay in the hospital.

"The patient did fine and there were no complications," he said.

The Phase II study, which is being sponsored by Vascutek parent company Terumo Cardiovascular Systems (Ann Arbor, Michigan), intends to enroll 180 patients at 20 centers.

"The primary endpoint is feasibility and safety of the device," Rodriguez said. "We're looking into complication rates and following up with the patients and any technical issues that compare to other devices and techniques."

The control group will be AAA patients who undergo open surgery. Investigators will also use historical data to compare complication and success rates as well as mortality.

The typical mortality rate for open surgery within 30 days after procedure is in a range of 4% and 10%. The goal of this study is to stay at 4% or lower.

Rodriguez said the new stent system would require no particular training for surgeons familiar with endovascular techniques.

"Of course, there is a learning curve in first five to 10 cases, but it's not difficult," he added.

The study is expected to end within 1-1/2 years and patients will be followed for up to five years.

Elsewhere in the product pipeline:

• AccessClosure's (Mountain View, California) plans to gain ground in the manual compression market have come to fruition with the FDA approval of the M5, an addition to the Mynx Vascular Closure family. The company, which was formed in 2002, is touting the device as the only one on the market that can be delivered through a small 5 Fr cardiovascular sheath without enlarging the arterial hole or traumatizing the surrounding tissue in the process. The approach is being called artery-friendly and is said to benefit hospitals, as the M5 stops the need for a sheath exchange, which saves time and expense. The Mynx Vascular Closure Device was first approved by the FDA for 6 Fr and 7 Fr cardiovascular procedures in May 2007. Since its full market release, the Mynx has been used in more than 225,000 patients in some 700 hospitals nationwide. Like the original Mynx device, the Mynx M5 offers patients the same important benefit – a comfortable closure experience. The device achieves femoral artery hemostasis via extravascular delivery of polyethylene glycol, a biomaterial commonly used in medical devices and pharmaceutical products.

• Accumetrics (San Diego) said that it has reached the halfway mark (1,600 patients) in the enrollment of its landmark clinical trial, GRAVITAS. The trial is specifically designed to demonstrate the value of providing clinicians with actionable information for patients who are poor responders to clopidogrel (Plavix). The trial will determine whether tailored antiplatelet therapy for poor responders, identified based on the results of the company's VerifyNow P2Y12 Test, reduces major cardiovascular adverse events (e.g., heart attack, stent thrombosis) following percutaneous coronary intervention.

• Alcon (Huenenberg, Switzerland) said that it has discontinued development of anecortave acetate for the reduction of intraocular pressure (IOP) associated with glaucoma. The company recently reviewed interim efficacy and safety data from more than 200 patients in a large, controlled Phase 2 trial. These data confirmed previous pilot clinical results that anecortave acetate applied through a single anterior juxtascleral injection measurably reduced IOP for an extended period of time. However, based on a detailed analysis of the data, and after gaining input from a panel of expert clinical advisers, the company determined that the amount of IOP reduction and the responder rate provided by even the highest dose were not sufficient to support this novel approach as a viable way to address the problem of patient compliance with eye drop therapy.

• Astra Tech (Waltham, Massachusetts) reported the availability of expanded Atlantis abutment options for Straumann dental implants. Following the recent launch of Atlantis abutments in titanium and gold-shaded titanium for Straumann Bone Level 4.1 and 4.8 implants, Atlantis abutments in zirconia are now also available for these Bone Level implants. Astra Tech is also introducing Atlantis abutments for the Straumann Standard Plus NN (Narrow Neck) 3.3 implant in titanium and gold-shaded titanium. Atlantis abutments are designed and fabricated using Atlantis VAD (Virtual Abutment Design) software, a process that combines 3-D optical scanning, advanced software and manufacturing methods to deliver patient-specific abutments that eliminates the need for hand modification.

• ATS Medical (Minneapolis) reported FDA clearance and the first implant of the ATS Simulus Semi-Rigid Annuloplasty Band. The Simulus Semi-Rigid Annuloplasty Band was developed through the company's collaboration with Genesee BioMedical and represents the latest addition to the expanding portfolio of valve repair products. Annuloplasty rings and bands are used in those cases where repair of a patient's heart valve is preferable to replacement of the valve. This new repair product has clinical applications that expand the existing therapeutic options for surgeons and their patients. The Simulus Semi-Rigid Band is specifically designed to respect the natural motion of the mitral annulus during the cardiac cycle allowing for a more physiologic valve repair. This unique characteristic can be particularly important in patients where both the aortic and mitral valves are being treated.

• Coapt Systems (Palo Alto, California) reported the launch of Hydrelle, a new, FDA-approved hyaluronic acid based dermal filler for the treatment of facial wrinkles, such as nasolabial folds, also called "smile lines." Coapt claims that Hydrelle is the first FDA-approved hyaluronic acid filler formulated with an anesthetic (lidocaine) for greater patient comfort. Hydrelle is indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Hydrelle has been specifically formulated to deliver rapid results comparable to other hyaluronic acid fillers; and the lidocaine anesthetic is integrated, providing a more comfortable injection experience for patients. Hydrelle represents an alternative for patients seeking a safe and cost-effective filler option, since patients only require approximately 50% of typical injection volumes, thus requiring fewer syringes to fully correct facial wrinkles.

• Cook Medical (Bloomington, Indiana) has introduced a device designed to protect and guide embryos through cervical mucus and blood and to eliminate the need for cervical flushing and aspiration prior to transfer. According to the company, the Guardia Pro Protective Embryo Transfer Catheter's outer sheath protects the embryo through entry and then opens in petals to further advance the inner transfer catheter, allowing placement of the embryo in the uterine cavity. The company said that the transfer catheter also incorporates Cook's Microvol technology that decreases the volume of fluid required for embryo transfer helping lessen the likelihood of embryo migration and allowing more accurate embryo placement. The Guardia Pro is Cook's newest addition to its portfolio of products for assisted reproductive technology. "The launch of the Guardia Pro is an important step forward for the industry and for those undergoing IVF," said Christina Anné, VP of Cook's women's health business unit. "Our unique product creates a greater opportunity for successful embryo implantation. We are committed to simplifying procedures for patients and clinicians and with this device we hope to improve the process of embryo transfer." Separately, Cook Medical reported that favorable data was presented for its Biodesign, for the treatment of abdominal wall wounds complicated from chemotherapy. According to research, the Biodesign Hernia Graft is safe and effective in treating chemotherapy patients suffering from hernias for which synthetic mesh is not a viable option. The study shows that Biodesign is particularly effective at treating high-risk patients with preoperative abdominal wall morbidity, gastrointestinal perforation and those patients receiving hyperthermic intraperitoneal chemotherapy or cytoreductive surgical procedures. The graft also proved to reduce postoperative adhesions, reduce the risk of surgical site infection and eliminate enterotomies of fragile bowel after chemotherapy during subsequent surgeries in this study.

• Hema Metrics (Salt Lake City) and CHF Solutions (Brooklyn Park, Minnesota) jointly reported that the Hema Metrics Crit-Line technology is now available in the Aquadex FlexFlow device manufactured by CHF Solutions.The Aquadex FlexFlow is used to deliver Aquapheresis therapy, a safe, predictable, and effective method to remove excess salt and water from patients with fluid overload. The integrated Crit-Line technology, called CRIT-SAT, allows for the non-invasive measurement of hematocrit and oxygen saturation during the Aquapheresis fluid removal process. This additional information provides an early window on each individual patient's hemodynamic response and helps ensure the most appropriate fluid removal is achieved.

• Nephros (River Edge, New Jersey) reported that is has FDA approval to market its Dual Stage Ultrafilters (DSU) for in-line purification of dialysate water and bicarbonate solution. The DSU is the basis for Nephros's line of water filtration products. The dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its filtration levels, filter out many viruses, parasites and biotoxins. The company claims the Nephros DSU filters particles down to the 0.005-micron level and addresses dialysate contaminants at crucial points: after the reverse osmosis module and at the dialysis machine entrance from the water distribution loop. The DSU filter can be used as the last step in the water purification process to ensure ultra pure water for dialysis procedures.

• Positron (Indianapolis) reported the introduction of a cardiac optimized PET scanner, the Attrius and portable FDG dose administration system, the Tech-Assist. The Attrius PET scanner is designed for cardiac optimized PET imaging and offers standard whole body imaging capabilities. Whole body imaging with sodium fluoride is becoming a viable and relevant alternative to SPECT imaging due to the recent molybdenum shortage. Positron's Tech-Assist is a portable dose administration system that reduces worker exposure during PET injection applications, including FDG, sodium fluoride for whole body bone imaging, as well as, new F-18 agents that are injected by a syringe.

• Over a two-year period from 2006 to 2008, Medicare's Recovery Audit Contractor (RAC) demonstration program corrected more than $1.03 billion in improper Medicare payments. During the demonstration, auditors recouped $992.7 million in Medicare payments, or 96% of the improper payments; more than 85% of those overpayments were collected from our nation's hospitals. And 60% of these payment recoveries occurred in 2008, suggesting a continued trend of hospitals returning funds to Medicare once the permanent RAC program is fully implemented by January 1, 2010. To help hospitals properly prepare for a nationwide RAC program, the Premier Healthcare alliance (San Diego) has enhanced its RAC preparation and management solutions that assist providers in achieving maximum revenue retention. In June, Premier acquired Phase 2 Consulting, which offers expertise and consulting capabilities around RAC readiness and charge capture, revenue cycle services, strategic planning and service line analysis.

• SensiVida Medical Technologies (Henrietta, New York) reported that it has received written clearance from the Western Institutional Review Board (WIRB) of Olympia, Washington, to begin clinical trials of its minimally invasive allergy test system. The company claims that its optical-digital "platform" technology addresses a number of multi-billion dollar market opportunities - disease-state diagnostics: allergy testing, pain-free automated glucose monitors without bio-fouling, blood coagulation testing, TB testing, and cholesterol monitoring.

• Spectrum Health (Grand Rapids, Michigan) and Medicity (Salt Lake City) said that they have deployed a platform that enables secure health information exchange between hospitals and physicians for enhanced clinical decision-making, care coordination and patient safety. The platform jointly deployed by Spectrum Health and Medicity is being offered to physicians throughout West Michigan. This solution integrates clinical information with the electronic medical record at a physician's office. In addition, if an office is still using paper charts, Spectrum Health supplies a bridge solution so they can start interacting electronically. More than 75 physician offices across eight counties in Michigan now receive data electronically from Spectrum Health and an additional 70 offices are in the process of being connected.

• Leading interventional pain physicians from key U.S. centers gathered at a special June 29 clinical symposium to share their experience with Vertos Medical (Aliso Viejo, California) introduced it's new product — mild (Minimally Invasive Lumbar Decompression), a least invasive surgical procedure for treating lumbar spinal stenosis (LSS), with no implants left behind. The company says that early clinical testimonials from physicians suggest that mild may be an appropriate treatment alternative earlier in the LSS progression, as mild patients have shown favorable results when comparing post-treatment improvement at three months to open surgical procedure patient results at one year. Moreover, mild leaves future surgical options open. Cleared by the FDA for decompression of the lumbar spine, mild is an image-guided procedure performed through a skin puncture the diameter of a pencil. Using mild devices, the physician removes the bone or tissue that is causing the pressure on the nerves.

• W.L. Gore & Associates (Flagstaff, Arizona) said that it has received FDA approval for a manufacturing change to the Gore Viabahn Endoprosthesis. The modification is a result of the precision laser trimming technology which enables the removal of excess material at the device margin, resulting in a contoured edge. Gore claims the device is the only stent-graft approved by the FDA for the treatment of patients suffering from Peripheral Arterial Disease (PAD) in superficial femoral artery (SFA) lesions and iliac artery lesions. The Viabahn endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The flexibility of the endoprothesis enables it to traverse tortuous areas of the SFA and to conform to the complex anatomy of the artery. The endoprothesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference diameters ranging from 4.0 mm – 7.5 mm.