FDA clears surgical fluid management system
Thermedx has received FDA market clearance to sell its 37-5 Fluid Management System (A) to hospitals and ambulatory surgery centers in the United States. The system combines the functionality of five narrow-use irrigation products into a single device, enabling users to manage and/or warm irrigation fluids efficiently and cost-effectively during orthopaedic, urologic, gynecologic, and general surgeries, according to Thermedx.
For more information, visit www.thermedx.com
Integrated PM, EMR system
The SRS Care Tracker PM merges the Web-based practice management (PM) and scheduling systems from Ingenix with the SRS hybrid electronic medical record (EMR) system. The fully integrated system is designed to optimize physician practice productivity by combining clinical and business workflows into one comprehensive system to save staff time and enhance efficiency.
For more information, visit www.srssoft.com
New spacer being tested for spinal stenosis
The Superion™ Interspinous Spacer from VertiFlex, Inc., is placed percutaneously between the spinous processes, without cutting paraspinal muscles, to treat neurogenic intermittent claudication and leg pain commonly associated with spinal stenosis. The titanium metal implant is delivered via a small cannula through a quarter-inch incision made posteriorly to the midline. Performed under local anesthesia, the average surgery time is reportedly 25 minutes or less. The device is currently undergoing clinical testing at hospitals across the United States.
For more information, visit www.veriflex.net
Knotless anchor for rotator cuff repair
A self-punching rotator cuff anchor, the VERSALOK® PEEK (B)from DePuy Mitek is radiolucent, knotless, and designed for maximum pull-out strength. The new nonmetallic anchor reportedly eliminates the need to pre-awl a pilot hole (except in very hard bone), will not interfere with magnetic resonance imaging (MRI) scans, and allows sutures to be affixed more quickly.
The VERSALOK PEEK System, which includes the anchor and suture, also features a reusable deployment gun that allows for appropriate tensioning of the suture and is compatible with both VERSALOK and VERSALOK PEEK knotless anchors.
For more information, visit www.depuy.com
A portable upgrade to digital radiography
The recently FDA-cleared FDR D-EVO™ (C) from FUJIFILM Medical Systems, Inc., is a portable flat panel detector that fits into existing X-ray equipment, providing orthopaedic practices an affordable upgrade to digital radiography (DR). The retrofit enables practices to insert the DR detector directly into the existing X-ray table or wall stand without modification.
The FDR D-EVO weighs 6 pounds and measures 14 inches by 17 inches, providing portability to address lateral or other cassette-based exams as needed. It can also be used for cross-table exams in existing DR rooms and in the operating room and emergency department where immediate access to images is critical.
For more information, visit www.fujimed.com
Electrosurgical probe targets diseased cartilage
NuOrtho Surgical, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Ceruleau™ surgical probe for the treatment of soft tissues and fibrillated articular cartilage. The 3.5-mm arthroscopic radio frequency (RF) electrosurgical probe is designed to aid the surgeon by selectively targeting diseased cartilage tissue during procedures intended to restore smooth chondral surfaces.
According to the manufacturer, studies have demonstrated that Ceruleau’s design, which combines low RF energy delivery with a protected electrode (to avoid electrode-to-tissue contact), allows for localized treatment of damaged/fibrillated cartilage tissue while avoiding harm to healthy cartilage.
For more information, visit www.nuorthosurgical.com