The Alair Bronchial Thermoplasty System from Asthmatx, on which we have reported several times before, has now received FDA approval. Indication is currently limited to the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists, the current standard-of-care treatment for these patients. Thermoplasty is the first approved non-drug treatment for asthma.
Press release: Asthmatx Receives FDA Approval for the Alair Bronchial Thermoplasty System…(pdf)
Product pag: Asthmatx…
Flashback FDA Panel Recommends Bronchial Thermoplasty Approval for Select Patients; Bronchial Thermoplasty Does Well in AIR2 Trial; Alair System May Become Option for Asthmatics; The Alair System for Bronchial Thermoplasty; FDA Panel Recommends Bronchial Thermoplasty Approval for Select Patients
Thoracic Surgery Archives
Alair Bronchial Thermoplasty System Receives FDA Approval
AIGISRx Anti-Bacterial Patch Helps Prevent Post-Surgery Infection in Soft Tissue
The FDA has given New Jersey based TYRX, Inc. 510(k) clearance for its AIGISRx ST anti-bacterial patch for soft tissue repair. The material was previously FDA cleared for use in an envelope which reduces risk of infection following implantation of a pacemaker or cardioverter-defibrillator, and in its newly approved use it will help prevent post-operative infections in soft tissue.
From the product page:
PoleStar N30 Surgical MRI System Launched
Medtronic has announced U.S. launch of the PoleStar N30 Surgical MRI system, which is aimed at neuro-oncologic surgery. The system provides real-time MR imaging in the operating room enabling accurate targeting and navigation despite movement that may occur during a surgical procedure. It can be used to plan the optimal surgical trajectory to a brain tumor, to achieve complete tumor resection while avoiding healthy tissue and critical structures, and to verify complete tumor resection. The PoleStar system allows for image fusion of pre-operative diagnostic scans (CT, MR, PET and fMRI) with intra-operative images and features T1, T2, Flair and e-steady (combination of T1 & T2) sequences. Intra-operative scanning times range from 8 seconds to 13 minutes. The system is innovative in that it brings MR imaging to the operating room instead of having to operate in a dedicated MR suite.
Press release: Medtronic Launches Award-Winning Neuro Oncology Surgical Imaging System in the United States…
ZeroWire Duo Brings HD Video to the Operating Room
San Jose, CA based NDS Surgical Imaging has received 510(k) clearance from the FDA for its ZeroWire Duo, a video solution for minimally invasive surgical and interventional procedures which wirelessly transmits high definition video in real time. The system is able to stream 1080p video using H.264 compression, and utilizes 128-bit encryption to prevent unauthorized access to the wireless signal.
Some specifications from the press release:
CareFusion EnView Holds the Camera During Laparoscopy
CareFusion (San Diego, CA) has launched the EnView, a device used to hold and maneuver a laparoscope allowing surgeons a clear and stable view of the anatomy. Typically, during laparoscopic surgery an assistant holds the camera for up to several hours. The new device frees up those hands while providing increased camera stability and helps avoid fatigue, hand tremors and miscommunication. The device accommodates 5mm and 10mm endoscopes and integrates with a hospital’s existing visualization equipment. Its clamping system provides flexibility of placement with little or no interference with other working ports, and its one-handed endoscope removal allows for easy cleaning. The device uses hydraulic technology and operates without the need for electricity or software.
Press release: CareFusion’s New Camera Controller Improves Surgical Field Visibility During Minimally Invasive…
Advertisement
Bioresorbable Sealant Patch Gets FDA Approval
The FDA has approved Nycomed Austria GmbH’s TachoSil, an absorbable sealant patch designed to prevent bleeding from small blood vessels after cardiovascular surgery. The patch is composed of collagen from horse tendons, and coated with fibrinogen and thrombin which are extracted from donated human plasma. When applied to the wound site, the thrombin and fibrinogen combine to form fibrin monomers, and endogenous factor XIII facilitates the cross-linking of these monomers, forming an air- and liquid-tight seal.
From the press release:
CareFusion Diagnostic Catheter Helps Determining Causes of Hospital-Acquired and Ventilator-Associated Pneumonia
Carefusion, San Diego, has just launched its AirLife Diagnostic Catheter, a kit that helps in obtaining lower respiratory tract samples in patients who are on a ventilator to accurately diagnose lung infections. It uses a “mini” bronchial-alveolar lavage (mini-BAL) technology to obtain a specimen from the lower respiratory airway at a patient’s bedside. The device can be operated by one person and the airway access adapter maintains positive end expiratory pressure (PEEP) throughout the procedure. A self-sealing sample chamber minimizes contamination risk.
Press release: CareFusion Launches Diagnostic Catheter to Help Clinicians Accurately Determine Causes of Hospital-Acquired and Ventilator-Associated Pneumonia…
Envisionier endogoHD Portable Endoscopy System
Envisionier out of Woodstock, GA recently released what they claim to be is the “world’s first battery operated, portable, hand-held endoscopic video camera with integrated viewing and archiving capability.”
Light Source Optimization Technology
ENDOPATH XCEL Trocar with OPTIVIEW Keeps The Lens Clean for Superior Visualization
Johnson & Johnson’s Ethicon Endo-Surgery is releasing an updated version of the company’s ENDOPATH XCEL trocar, now featuring OPTIVIEW technology for cleaning around the endoscope’s lens. A smeared lens and poor visualization commonly occur by going through a trocar with an endoscope, hence by evacuating liquids from the visual path the firm promises to “virtually eliminate trocar-induced smudging”.
New OPTIVIEW™ Technology in the ENDOPATH® XCEL™ trocars is designed to carefully wipe bodily fluid or debris from the endoscope shaft and draw the fluid through wicking channels out radially towards the absorbent ring. The fluid is then contained within the absorbent ring, keeping the endoscope clear upon trocar reinsertion, thus helping to provide optimal views of the surgical field. This trocar with superior visualization is equipped to provide the established performance of previous ENDOPATH® XCEL(tm) trocars, including seal durability, low drag force, abdominal wall retention and low port site herniation.
