Centerline Biomedical, a company based in Cleveland, Ohio, landed FDA clearance for its Intra-Operative Positioning System (IOPS). The product provides physicians with a radiation-free way to navigate through vasculature during minimally invasive procedures. Currently, X-ray fluoroscopy is used to track where minimally invasive instruments are in a (Read more...)
Tag: Vascular Surgery
Blood Flow Measurement Using Tiny LED Catheter
Measuring blood flow is important during a variety of surgical procedures, as well as in intensive care settings. Typically, this is performed intermittently, so there’s not a lot of temporal detail in the readings. Now, a team of researchers at Flinders University in Australia has developed a proof-of-concept prototype vascular catheter that (Read more...)
Radiation-Free Guidance for Vascular Catheters Using Smart Fiber Optics
While modern catheters can reach into various parts of the body, navigating there remains a major challenge. Fluoroscopes that emit X-rays are used to constantly keep track of the catheter location, but they emit ionizing radiation and require a great deal of protection to be used by clinicians. Engineers at the Fraunhofer Institute for Digital [&h (Read more...)
Artis icono Angiography Suite Now Includes Virtual Patients to Practice On
Siemens Healthineers has partnered with Mentice, a Swedish company that specializes in simulation solutions for endovascular therapies, to integrate the Artis icono angiography system with the VIST Virtual Patient offering. Many of today’s advanced interventional procedures require quite a bit of training for physicians to perform them safely (Read more...)
Mimics Enlight Cardiovascular Planning Software Gets FDA Clearance
Materialise, a 3D printing company with a focus on patient-specific parts, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The product’s initial application will be in planning complex transcatheter mitral valve replacement (TMVR) procedures. Developed with the help of the Henry Ford Health System in (Read more...)
Project Moray Developing Robotic Intracardiac Catheter for Complex Interventions
Catheter-based surgical interventions are now routine, so much so that navigating to the heart from an access site in the groin is considered ho-hum. Once there, though, getting a catheter tip to the exact spot within the heart that requires treatment can still be exceedingly difficult. Unlike the vasculature used to get there, the heart […]
(Read more...)Patches Made of Heart Tissue Going to Clinical Trials
Stem cell therapies to heal damaged hearts have proven to be lacking so far, probably because simply injecting new cells into afflicted regions isn’t enough. Researchers from Imperial College London have now created patches made of cardiac tissue to sew over damaged areas of the heart. These patches, which can beat on their own to […]
IMPEDE-FX Embolization Plug Cleared in U.S. for Peripheral Arteries
Shape Memory Medical, a company out of Santa Clara, California, won FDA clearance for its IMPEDE-FX Embolization Plug. The new device is to be used as an adjunct to the firm’s IMPEDE Embolization Plug, which is already FDA cleared. The two devices have been developed to cause deliberate obstructions or to reduce blood flow in […]
Bioabsorbable Wound Dressing with Nanoscale Chitosan to Rapidly Stop Bleeding
Chitosan is a sugar compound derived from the exoskeletons of shrimp, crab, and other shellfish. It is used extensively in medicine, including in dressings, because of its well known hemostatic properties. These properties work at the nanoscale, so delivering tiny bits of chitosan to the site of a wound can help improve how it works […]
Philips Unveils IntraSight Multi-Modality Imaging Platform
For years, catheter-based minimally invasive procedures have depended on X-ray imaging to guide physicians toward the treatment site. New tools, including intravascular ultrasound (IVUS) and fractional flow reserve (FFR), which measures blood pressure inside a vessel, are giving physicians additional perspectives. Using these modalities in a single (Read more...)
Prevena Negative Pressure System FDA Approved for Superficial Surgical Site Infections
KCI, now a part of the Acelity Company, has announced that its PREVENA negative pressure incision management system is the first to receive FDA’s indication to help with reducing superficial surgical site infections in those at high risk of post-op infections. The approval comes under the FDA’s de novo pathway that was designed to bring (Read more...)
Prevena Negative Pressure System FDA Approved for Superficial Surgical Site Infections
KCI, now a part of the Acelity Company, has announced that its PREVENA negative pressure incision management system is the first to receive FDA’s indication to help with reducing superficial surgical site infections in those at high risk of post-op infections. The approval comes under the FDA’s de novo pathway that was designed to bring (Read more...)
FDA Approves More Accurate GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Gore just announced winning FDA approval for its GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The thoracic endovascular aortic repair system is based on the Conformable GORE TAG Device, but with a new, more robust control mechanism that helps to position the implant with greater accuracy and confidence. The implant its (Read more...)
World’s First Surgical Vending Machine
Xenco Medical, a company that makes disposable spinal tools and implants, is unveiling a vending machine for tracking and dispensing these devices. Clinicians have a huge touchscreen display to choose what they’d like to retrieve out of the machine. The same display can be used to get some specs on the various devices and watch […]
High Strength VICI Venous Stent Approved by FDA to Treat Iliofemoral Obstructive Disease
Boston Scientific won FDA approval for its VICI VENOUS STENT for treating iliofemoral venous obstructive disease, a condition in which the veins in the pelvic region become blocked due to a clot or pressure from nearby anatomy, such as caused by May-Thurner syndrome. Because this stent is expected to be positioned in a place where […]
UC Davis First to Get Canon’s Ultra-High Resolution CT
Clinicians at the University of California, Davis Health are now scanning patients using an Ultra-High Resolution CT scanner, the only of its kind in the United States. The Aquilion Precision from Canon Medical Systems is able to resolve things down to the 150 micron level, allowing for diagnostic insights previously impossible. The capability is m (Read more...)
CleanCase Device-Specific Smart Sterile Covers Going on Sale
SteriDev, a Lansing, Michigan firm, is releasing the first device-specific sterile mobile device coverings. The CleanCase coverings are FDA-compliant and allow surgeons, technicians, and other clinical staff to use smartphones and tablets even in the operating room (OR). These days, it can be quite a hassle to bring a smartphone in the OR, making i (Read more...)
Guerbet’s SeQure and DraKon Peripheral Microcatheters Cleared in Europe
Guerbet, a French firm, won European regulatory approval to introduce its SeQure and DraKon peripheral microcatheters on the continent. The devices are indicated for infusion of contrast media, drugs, and embolic materials as part of vascular embolization procedures. The devices were originally developed by Accurate Medical Therapeutics, an Israeli (Read more...)
Tack System for Repair of Angioplasty Endovascular Tears FDA Approved
Balloon catheters have revolutionized the treatment of vascular diseases, but when they’re used to push plaque against the walls of vessels tears can form. These tears can have significant impact on the integrity and hemodynamics of vessels and therefore on the health of patients. Stents can be used to address these, but stents are typically (Read more...)
HEMAsavR Helps to Recover More Intraop Blood
Ecomed Solutions, out of Mundelein, Illinois, is releasing its HEMAsavR device for blood capture and transfer during surgeries. The product helps to avoid allogeneic blood transfusions by not requiring specialized resources for collection and return to patient. Hospitals will therefore be able to gather more useful sterile and anti-coagulated blood (Read more...)