FDA Grants Expanded Approval for Medtronic Defibrillator

Medtronic Inc. has received approval for an expanded indication from the U.S. Food and Drug Administration (FDA) for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices. Previously, the CRT-D devices were approved for use only in more serious cases of heart failure risk; now, the devices can be used earlier to treat mildly symptomatic heart failure patients. This potentially could improve survival rates, reduce hospitalizations, and prevent the heart condition from worsening.

The REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) clinical trials were the basis for the expanded FDA approval. The trials, initiated in 2005, demonstrated the benefit of using CRT-D devices in patients earlier, showing that this can reduce mortality rates.

REVERSE studied 610 patients and was the first large-scale, global, randomized, double-blind trial to demonstrate the impact of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms. In the trial, the CRT delayed the time to first heart failure hospitalization in this patient group and reduced heart failure hospitalization or all-cause death by 51 percent. RAFT patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow up and largest patient months of experience of any study of CRT therapy. The trial demonstrated a 29 percent reduction in mortality in patients who used the CRT-D, and a 27 percent reduction in combined mortality and heart failure hospitalizations for this population, according to Medtronic.

“The RAFT and REVERSE study findings provide strong clinical evidence validating the safety, efficacy and lifesaving benefits of CRT-D for treating systolic heart failure patients with milder symptoms,” wrote Michael R. Gold, M.D., Ph.D., REVERSE study investigator and Michael E. Assey, M.D., steering committee member and professor of medicine and director of cardiology at the Medical University of South Carolina. “This expanded indication fulfills an unmet need by treating these patients in the earlier stages of heart failure, before their symptoms more significantly impact their quality of life.”

Certain New York Heart Association Class II patients, who now are eligible for CRT-D devices, previously only were able to get an implantable cardioverter defibrillator to protect them from sudden cardiac arrest, a condition responsible for more than 60 percent of deaths among the mild-to-moderate heart failure population.

Minneapolis, Minn.-based Medtronic Inc. is focused on the cardiovascular and spinal device sectors.

Devon Medical Receives Clearance for Wound Care Device
Devon Medical Products, headquartered in King of Prussia, Pa., has received 510(k) clearance from the U.S. Food and Drug Administration for its extriCARE 2400 negative pressure wound therapy system.

The extriCARE 2400 is a pump and bandage combination that creates negative pressure, or suction, over the wound. The anatomically fitted bandages create a seal around the area and can be used on various parts of the body. Via the suction, blood is drawn to the wound bed and exudates are collected in a disposable canister. Devon notes that the 8.6-ounce extriCARE pump should accelerate wound healing and shorten the amount of time spent on wound preparation.

Specific wounds the device is designed to manage are chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic and pressure ulcers, flaps, and grafts. extriCARE can be used in acute hospital settings, wound clinics, nursing homes, and inside the home under supervision of a trained healthcare professional, according to the company. The device is still pending a patent.

Devon Medical Products is a global medical device manufacturer, designer, and distributor. The company primarily is focused on devices that treat various types of swelling and wounds related to disease states ranging from lymphedema to diabetes.

FDA Says Yes to Toshiba’s New CT System
Tustin, Calif.-based Toshiba America Medical Systems Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for its Aquilion Prime 80 series CT (computerized tomography) system. According to the company, Aquilion Prime produces high-quality clinical images, and is designed to reduce radiation exposure with Adaptive Iterative Dose Reduction 3D. The system can generate 80 unique “slices” per rotation, but also can be upgraded to generate 160 slices.

Tim Nicholson, senior manager of market development, CT Business Unit, Toshiba, said the Aquilion system would give hospitals the “opportunity to conduct advanced exams in mere seconds and grow clinical abilities based on patient needs results in improved patient care and overall departmental efficiency.”

The Aquilion Prime features a 0.5 mm detector, a 7.5 MHU large-capacity tube and 0.35 second scanning. The high-speed rotation allows rapid data acquisition and shortens scan times while the fast reconstruction unit further improves throughput, all of which help provide faster, safer and more accurate diagnoses. The system also features a 78 cm aperture gantry, the largest currently available in a high-end CT system. The combination of a 660-pound patient-weight-capacity couch with a large gantry bore optimizes the system for routine clinical scanning or bariatric patient studies.

To reinforce the principle of As Low As Reasonably Achievable imaging, AIDR 3D and NEMA XR 25 Dose Check Software are standard features on the Aquilion Prime 80 series. AIDR 3D, the newest dose-reduction technology for the Aquilion CT product line, is an iterative process that helps to remove noise from the image with reduced radiation dose. Among other features the company touted, Toshiba’s NEMA XR 25 Dose Check Software is designed to enhance user awareness of the radiation dose being administered to patients. The software includes Dose Alert and Dose Notification, addressing the two main components of the Medical Technology and Imaging Alliance’s (MITA’s) CT Dose Check Initiative, as well as Tracking and Digital Imaging and Communications in Medicine (DICOM), to further enhance dose awareness. DICOM was founded by MITA to create a standard for how imaging information is communicated and disseminated.

Toshiba Medical Systems Corporation provides diagnostic imaging systems such as CT, X-ray and vascular, ultrasound, nuclear medicine and MRI systems, as well as information systems for medical institutions. Toshiba Medical Systems Corp. is a subsidiary of Toshiba.

Advisory Panel Recommends Approval of Ultrasound Cancer Screening System
The U.S. Food and Drug Administration (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee has recommended approval of the Somo-v Automated Breast Ultrasound (ABUS) system. Developed by U-Systems, the Somo-v currently has FDA clearance to be used as a diagnostic aid to mammography, but the company submitted a premarket approval application (PMA) with the agency to use the system as a cancer-screening tool.

Although the FDA is not obligated to follow the recommendation of review panels, it usually does. If the PMA is granted for the Somo-v, it would make the system the only ultrasound device in the United States approved for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. Studies indicate that dense breast tissue elevates the risk of breast cancer between four-fold and six-fold, but it also makes the detection of cancer more difficult, as the denser tissue hides possible tumors. Mammograms alone are not a sufficient diagnostic tool in women with dense tissue; U-Systems claims that its Somo-v not only can detect hard-to-see tumors, but also can detect them earlier.

Rachel Brem, M.D., director of breast imaging at George Washington University Hospital in Washington D.C., said hard-to-detect tumors make up approximately 30 percent of all tumors.
According to figures cited by the company, at least 40 percent of women in the United Stated have dense breast tissue.

U-Systems manufactures ultrasound technology for early cancer detection. The company is based in Sunnyvale, Calif.

Vertebral Augmentation System from Ascendx Gets the Nod from U.S. Regulators
Ascendx Spine is about to enter the U.S. medical device market.

Just five months after gaining approval in Europe to market two vertebral compression fracture (VCF) treatment products, the Winter Park, Fla.-based firm is preparing a commercialization strategy for its Acu-Cut Vertebral Augmentation System. The product was cleared by the U.S. Food and Drug Administration in late February.

Designed to treat spinal compression fractures, the Acu-Cut device is a uni-pedicular vertebral augmentation system designed to create a cavity for precise cement placement.

VCF causes a vertebra to collapse and the spinal column above it to assume an abnormal forward curve, resulting in considerable back pain and a “hunchback” appearance. Current treatments for VCFs include vertebroplasty and kyphoplasty—both of which are minimally invasive procedures. In vertebroplasties, doctors use image guidance to inject a cement mixture into the fractured bone through a hollow needle; kyphohplasties, on the other hand, feature a balloon that first is inserted into the fractured bone through the hollow needle to create a cavity or space. Cement then is injected into the cavity once the balloon is removed.

Traditional methods of VCF treatment require surgeons to pass next to both sides of the spinal cord in order to reach the entire vertebral body. The Acu-Cut system, however, can achieve such a feat through single-sided access, according to the company.

Shortly before Christmas last year, Ascendx Spine received CE Mark approval for the Acu-Cut system as well as the Ascendx VCF Repair System. The company tapped Paris, France-based distributor Spinaxis to oversee its marketing efforts in the country.

“We are very focused on market penetration throughout Europe of our Ascendx VCF Repair System and the Acu-Cut Vertebral Augmentation System, which are designed for the treatment of spinal fractures by spine surgeons and interventional radiologists,” Julian M. Mackenzie, Ascendx CEO, said when CE Mark approval was announced.