• Biotronik (Portland, Oregon) reported FDA approval and first implant of a Xelos DR-T, the company’s new high-energy implantable cardioverter defibrillator (ICD). The device is part of a system that incorporates Home Monitoring Early Detection technology, biphasic II shock capability, and 36-joule shock energy. The first implant of the Xelos DR-T was performed at Maricopa Medical Center (Phoenix) by Chief of Cardiology Edgardo Zavala-Alarcon, MD. “Biotronik’s Xelos DR-T combines a higher delivered energy with the revolutionary Home Monitoring feature, so that I can monitor and manage my patients’ advancing disease,” Zavala-Alarcon said. Events are automatically transmitted from the ICD to the Home Monitoring web site, which provides access to patient and device data anytime, from anywhere.

• Encelle (Raleigh, North Carolina) said it has completed a second human clinical trial for its E-Matrix treatment of diabetic foot ulcers. This controlled, randomized, 56-patient feasibility study provides the data necessary to design the next pre-market clinical trial, along with preliminary safety and efficacy results, the company said. The initial clinical trial results were presented at the Society for Advanced Wound Care annual meeting in San Diego last month, in which researchers found that the company’s ap-proach to healing diabetic foot ulcerations demonstrated the potential to improve healing rates with excellent safety. Additional results are being provided at this week’s annual Wound Healing Society meeting in Chicago.

• NuVasive (San Diego), which makes products for minimally disruptive surgical treatments for the spine, said it has launched the SpheRx Dual Ball Rod (DBR) Minimally Disruptive Fixation System for percutaneous posterior spinal fixation. The latest addition to the company’s MAS platform, the SpheRx DBR offers spine surgeons clinical and ease-of-use benefits, as well as seamless integration with the company’s NeuroVision Nerve Avoidance System. The SpheRx DBR system performs “instrument-free” compression, which allows the spine surgeon to easily apply up to 5 mm of compression by simply moving the DBR guides with his hands. The product design allows for a simple, constrained rod insertion achieved through a dual ball rod with spherical ends, which are geometrically constrained within the DBR Guides during rod insertion, guiding the rod directly and easily into the heads of the pedicle screws. The spherical ends of the rod fit securely within the screws at both ends of the construct with no rod overhang.

• R2 Technology (Sunnyvale, California) reported the launch of its ImageChecker CT Lung Version 2.0 computer aided detection (CAD) software system and AutoPoint temporal comparison feature for use during review of multi-slice CT chest exams. The second-generation software is designed to maximize physician accuracy and efficiency in finding actionable lung nodules early – when treatment can be most effective – and tracking nodule changes over time. The system also features expanded PACS integration for increased workflow efficiency. The ImageChecker CT Lung Version 2.0 CAD software system and AutoPoint temporal comparison tool will soon be made available as the only CT Lung CAD option integrated into the Vitrea workstation’s CT Lung visualization package, developed by Vital Images (Minneapolis).

• Smiths Medical MD (St. Paul, Minnesota) reported that it has received FDA 510(k) clearance and the CE mark for its Port-A-Cath II RDD Arterial Access System for the treatment of liver cancer. The Port-A-Cath II RDD is a site-directed arterial implantable access system designed to permit prolonged or repeated access to the arterial system for intra-arterial therapy. The system consists of a portal with a self-sealing silicone septum (accessible by percutaneous needle puncture), a single-lumen silicone catheter, a hemostasis sleeve assembly, and a 3 Fr micro-catheter assembly placed in the hepatic artery using an angiographic placement procedure. The company said its Port-A-Cath II RDD arterial access system is a less invasive alternative to the implantable pumps.