Boston Scientific won FDA regulatory approval to introduce the Eluvia drug-eluting vascular stent to the U.S. market. The device is the first peripheral stent to offer sustained release of an antiproliferative drug (paclitaxel) for as long as a full year. The drug prevents restenosis, a common condition caused by native tissue growing over the sten (Read more...)
Tag: Vascular Surgery
Paladin Carotid PTA Balloon with Embolic Protection Filter Cleared by FDA
Contego Medical, out of Raleigh, North Carolina, won FDA clearance for its Paladin carotid PTA (Percutaneous Transluminal Angioplasty) balloon catheter. The device, used to open up narrow arteries and to post-dilation of self-expanding stents, has a built-in embolic protection filter that traps any debris that may become dislodged and forced to flo (Read more...)
New Sniper Balloon Occlusion Microcatheters Cleared in Europe
Embolx, out of Silicon Valley, won the European CE Mark for its latest Sniper Balloon Occlusion Microcatheters. The devices are used to help deliver embolic agents in such varying procedures as helping to treat tumors, uterine fibroids, and enlarged prostate. The new family of the devices include features to make them easier to navigate throug (Read more...)
Versius Robotic Surgical System Unveiled by UK Company
CMR Surgical, a Cambridge, UK firm, is formally unveiling its Versius surgical robotic system that is designed to be portable, easy to setup, and, perhaps most importantly, affordable for hospitals that otherwise would have budget limitations obtaining existing robotic systems. The Versius is modular in its design, with the moving arms individually (Read more...)
New Smaller Flexible Robotic Surgical System from South Korea
At KAIST, a major South Korean science and technology university, researchers have developed a flexible robotic surgical system that is designed to work on difficult to reach places. The K-FLEX endoscopic surgical robot has arms that are only 3.7 mm in diameter, allowing them to work through standard 4.2 mm internal channels of an endoscope. [&hell (Read more...)
GORE Molding & Occlusion Balloon Approved in US, EU, Japan
Gore is releasing its GORE Molding & Occlusion Balloon following regulatory approvals in the U.S., Japan, and Europe. The device is a compliant polyurethane balloon catheter designed for use in opening up self-expanding stent grafts or to temporarily occlude wide vessels. The company believes that the device “meets all endovascu (Read more...)
Fundamental Surgery Virtual Reality Trainer with Force Feedback
FundamentalVR, a firm based in London, UK, is releasing in the United States its Fundamental Surgery virtual reality surgical simulator. The system uses off-the-shelf haptic feedback controllers to manipulate objects in the virtual world. This gives the user the ability to touch what feels like physical objects while working in the virtual scene. B (Read more...)
This Device Helps Improve Accuracy of Dialysis Catheter Placement
Patients on hemodialysis have to undergo vascular access procedures, typically arteriovenous fistulas or arteriovenous grafts. Some, though, are limited to tunneled cuffed catheters due to heart failure or poor cardiac reserve. Properly placing tunneled cuffed catheters can be challenging and failures can lead to serious complications such as (Read more...)
TIGERTRIEVER 13, World’s Smallest Clot Retriever for Strokes, Cleared in Europe
Rapid Medical, based in Yokneam, Israel, won European regulatory approval to introduce its TIGERTRIEVER 13, the narrowest clot retriever now available for use in treating ischemic stroke. The device can be used in vessels as small as 1 millimeter in width and up to a maximum of 2.5 mm, where larger retrievers would be appropriate. It work (Read more...)
Flow Diverter with Hemodynamic Sensor to Monitor Aneurysm Treatment
Flow diverters are implants that are commonly used to prevent blood from flowing into aneurysms. They look very similar to stents, and are often combined into one device, but instead of providing structural strength, they provide a way for blood to pass from one part of a vessel to another without flowing into a bulging […]
Surgery-Free Hemodialysis Fistula Creation With everlinQ endoAVF
TVA Medical of Austin, Texas, a newly acquired subsidiary of Becton Dickinson, won de novo marketing clearance from the FDA for its innovative everlinQ endoAVF system for creating arteriovenous fistulas for hemodialysis without relying on open surgery. The system relies on catheters inserted into adjoining arteries and veins. When in (Read more...)
New Smart Bandage Monitors Health of Wounds, Dispenses Drugs as Needed
When wounds are bandaged, they’re only being assessed when the bandage is replaced every so often. This is starting to feel like something from the olden times, as so many things in our modern world are constantly monitored and evaluated. Engineers from Harvard, Tufts, MIT, and other institutions have now banded together to create a [… (Read more...)
SOMAVAC 100, a Battery Powered Wearable Post Surgical Vacuum Pump
Some post-surgical wounds, including following abdominal surgeries and mastectomies, may require suction drainage to prevent post operative complications due to edema and fluid collections. Suction bulbs have been common for the past few decades, since they don’t require external power and are very simple in design. New technologies can signi (Read more...)
Smart Stent Monitors Blood Flow, Detects Restenosis
Vascular stents are some of the most commonly implanted medical devices, keeping millions of arteries open to uninterrupted blood flow. Though they tend to work well at first, too many end up being re-stenosed by new deposits of plaque and scar tissue often forms in the vicinity, blocking blood flow through the stent. Typically, renewed […]
TrapLiner 2-in-1 device Guide Extension Catheter with Guidewire Trapping Now Available in Europe
Teleflex is releasing in Europe its TrapLiner, a guide extension catheter and guidewire trap, that makes sure the guidewire stays in place and doesn’t move forward during catheter exchanges. This simplifies catheter exchanges in many cases, leading to faster completion of complex procedures. According to the company, “the TrapLiner® (Read more...)
Latest Avinger Pantheris Lumivascular Atherectomy System Cleared in U.S.
Avinger, based in Redwood City, California, just announced receiving FDA clearance for its next generation Pantheris Lumivascular atherectomy system. The product simultaneously provides intravascular imaging to allow surgeons to see the site of the disease and a tool to remove the built up plaque from within the targeted vessel. According to t (Read more...)
FDA Clears FlowTriever, First Device to Pull Blood Clots from Lungs
Inari Medical of Irvine, California won the first FDA clearance for a thrombectomy device to be used for treatment of pulmonary embolisms. The FlowTriever went through a clinical study involving 106 patients with acute pulmonary embolism and RV/LV (right ventricular/left ventricular) ratio of at least 0.9 that were treated using the device ins (Read more...)
New Technique to Measure Brain Blood Flow Using Light
Researchers at the University of California, Davis have developed a new method to measure blood flow in the brain using light. The method could provide a cheaper and more robust way to assess patients with traumatic brain injuries or stroke. The technique is based on the principle that shining a laser light through someone’s skull […]
Shockwave’s S4 Catheter Shakes Calcified Plaque Off Peripheral Arteries
Shockwave Medical, out of Freemont California, won European regulatory approval to introduce its Shockwave S4 Peripheral Intravascular Lithotripsy Catheter. The catheter can be used to work on arteries below the knees, shocking them with ultrasound to displace plaque compacted to the vessel walls. The frequency of the ultrasound is tuned to the res (Read more...)
Terumo Releases a Narrower Stent-Graft for TEVAR Procedures
Terumo is launching in Europe its RelayPro Thoracic Stent-Graft System, initially being released to a limited set of institutions with wider availability expected soon. The device is designed to allow patients with narrower access vessels to benefit from thoracic endovascular aortic repair (TEVAR) procedures. It’s based on the previously (Read more...)