Applied Tissue Technologies, based in Hingham, MA, won FDA clearance for its Platform Wound Dressing (PWD), the first embossed negative pressure wound therapy (NPWT) device that doesn’t require using any foam or gauze. The PWD has an adhesive base and an embossed membrane that keeps the wound isolated from the outside environment. The membrane, thanks to its […]
Tag: Vascular Surgery
iCertainty Contact-Free Perfusion Imaging System Cleared in U.S.
RFPi, a company out of Greenville, North Carolina, won FDA clearance for its iCertainty blood flow and perfusion imaging system. The technology gives clinicians the ability to essentially watch as blood saturates or drains in tissues being worked on, something that typically has to be done using invasive means. The new technology avoids injection of […]
Biodegradable Implantable Blood Flow Sensor
Researchers at Stanford University have developed a biodegradable blood flow sensor that can be wrapped around an artery during vascular surgery, and then monitor blood flow thereafter. The battery- and wire-free device can let a clinician know if a vessel is blocked, helping them to address complications after surgery before they become a significant problem. […]
First Device for Predicting Risk of Pressure Ulcers FDA Cleared
Pressure ulcers are a common malady for bedridden patients, a situation that clinicians have been struggling to improve significantly. There are devices that sense how long a part of a body has been pressed on for too long, beds that deflate and inflate different areas to provide temporary respite, and clinical routines that help to […]
FFRangio Uses X-Rays to Measure Fractional Flow Reserve, Now Cleared in U.S.
Fractional flow reserve (FFR) is a measurement of the blood pressure before and after a narrowing of an artery. The larger the difference in the pressure across the stenosis, the more need there is to perform an interventional procedure to open up the artery. Normally, FFR is measured using a special intravascular catheter and this […]
VASCADE MVP Venous Vascular Closure System for EP Procedures Approved in U.S.
Cardiva Medical won FDA approval for its VASCADE MVP Venous Vascular Closure System, a device used for multi-site venous closure post cardiac ablation, left atrial appendage closure, and other electrophysiology procedures. It’s available in sheaths from 6 to 12 French inner diameter The device is used to deliver a collagen patch onto the exterior of […]
Vanguard IEP Peripheral Balloon Angioplasty System with Emboli Filter Cleared in U.S.
Contego Medical, based in Raleigh, North Carolina, landed FDA clearance for its Vanguard IEP peripheral balloon angioplasty system. The product features the Congego’s proprietary Integrated Embolic Protection (IEP) technology that captures embolic debris breaking off from occlusions being treated within the superficial femoral artery. It was cleared last year in Europe under the CE Mark. The IEP component […]
Siemens Healthineers Releases Mobilett Elara Max X-Ray
Siemens Healthineers is releasing a new mobile, general purpose X-ray system, the Mobilett Elara Max. It features secure connectivity to the hospital’s IT systems to quickly store and retrieve the captured images, a design to make the unit easier to clean, and overall improved ergonomics for ease of use. The cabling has been integrated into the […]
REVA’s Fantom Encore Thin Strut Bioresorbable Scaffold Unveiled
REVA Medical, out of San Diego, California, has released its Fantom Encore bioresorbable scaffold. The implant is made with the company’s own Tyrocore polymer that is absorbed by the body over a period of some months, eventually disappearing while native tissue takes over. The process helps to make sure that the lumen stays open while cells grow […]
Medtronic’s Valiant Navion Thoracic Stent Graft Cleared in EU
Medtronic won European CE Mark approval to introduce its Valiant Navion thoracic stent graft for treating lesions within the descending thoracic aorta such as thoracic aortic aneurysms (TAA), blunt traumatic aortic injuries (BTAI), and penetrating atherosclerotic ulcers (PAU). The system received FDA approval in October of this year. The Valiant Navion is particularly beneficial for patients […]
PerQseal Absorbable, Sutureless Large-Bore Closure Device Coming to Europe
Vivasure Medical, a Galway, Ireland company, is launching in Europe its PerQseal closure device for use in large vessel femoral arteriotomies following large-bore transcatheter procedures, such as aortic valve replacements. Though minimally invasive transcatheter procedures have revolutionized cardiovascular care, closing the access sites created for them can be challenging. The PerQseal device is sutureless and, once placed, […]
Cios Spin Mobile 3D C-Arm for Orthopedic Surgery
Siemens Healthineers has unveiled a new mobile C-arm, the Cios Spin, that can provide both 2D and 3D imaging in just about any operating room. Mostly intended for orthopedic procedures, the device allows clinicians that are currently using 2D C-arms to upgrade to 3D capability and see things in a much more intuitive perspective. Positioning […]
3M’s New Durapore Advanced Surgical Tape for Keeping Tubes in Place
3M is releasing a new surgical adhesive tape that was developed to address special needs for a variety of clinical applications. The 3M Durapore Advanced tape is particularly beneficial when securing critical tubes that have to stay in place without a danger of being moved (chest tubes, JP drains, etc). The new product line adheres […]
Barco’s New 27″ 4K Surgical Monitor
Barco is releasing a new 4K surgical monitor that’s designed to give clinicians a high fidelity live image during interventional procedures. The Barco MDSC-8427 has a 27” screen, providing a new, larger size over common 24″ and 26″ monitors. The display features the company’s smart image processing technology optimized to improve how live video comes through. A […]
FDA Approves Valiant Navion Thoracic Stent Graft for Patients with Narrow Iliac Arteries
Medtronic received FDA approval for its Valiant Navion thoracic stent graft, a minimally invasive system for correction of lesions within the descending thoracic aorta, particularly in patients with narrow iliac arteries. The device is indicated in thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas, and aortic type B dissections. Patients with […]
Microlaparoscopic Robotic Surgeries Now Cleared on TransEnterix Senhance System
TransEnterix, the maker of the Senhance robotic surgical system, won FDA clearance for its new 3 millimeter line of instruments, as well as some more 5 mm instruments. At only 3 mm in diameter, the new instruments make it possible to use the Senhance system for microlaparoscopic surgeries with incisions so small that, once healed, are […]
Tiny New Endoscope for Looking Inside Blood Vessels
Cambridge Consultants, a UK firm, and OmniVision, based in California, have developed an impressive intravascular camera. It produces native images at 400 x 400 pixel resolution, considerably better than existing fiber-optic angioscopes, but engineers at Cambridge Consultants believe this can be boosted to 1,600 x 1,600 with its own software technique that “harnesses deep learning […]
B-Laser, The First 355nm Laser for Peripheral Artery Disease Cleared by FDA
Eximo Medical, based in Israel, won FDA clearance for its B-Laser Atherectomy System that’s used to clear out plaque from within narrowed peripheral arteries, including in cases of in-stent restenosis. The laser operates at a 355nm wavelength, the only one of this kind, and the company believes that this wavelength has benefits over the commonly […]
Thromboresistant Hydrogel Materials for Venous Catheters: Interview with CEO of Access Vascular
Access Vascular, based in Massachusetts, has developed a peripherally inserted central venous catheter (PICC) composed of a thromboresistant hydrogel material. The catheter could reduce the incidence of catheter-related thrombi and resulting adverse events. When a catheter encounters blood, blood cells and proteins begin to accumulate on its surface. The surface material of the catheter, along […]
TransEnterix Gets FDA Green Light for Senhance Ultrasonic Instruments for Its Robots
TransEnterix, one of the new competitors in the minimally invasive robotic surgery market, received European CE Mark approval for its Senhance Ultrasonic Instrument System. The instruments are used on the TransEnterix Senhance robitically assisted surgical system, that features haptic remote control of laparoscopic tools that let the surgeon feel what the instruments are coming in […]