Imaging the heart for signs of disease is still quite rudimentary. While CT, ultrasound, and PET (positron-emission tomography) scanners generate impressive looking graphics, they’re a long way from giving doctors a true representation of the anatomy and function of the heart and nearby vasculature. Contrast agents are widely used to allow th (Read more...)
Tag: Cardiac Surgery
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...)
CorMatrix Cor PATCH for Repair of Broken Hearts Gets FDA Clearance
CorMatrix, a company out of Roswell, Georgia, has won FDA clearance for the Cor PATCH epicardial patch. The device is indicated for use at the locations of aneurysms, in adults who have suffered a heart attack that led to the ventricular walls becoming thinner, or anywhere else where structural support or repair of the heart would […]
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...)Meril Myval Transcatheter Aortic Valve Cleared in Europe
Meril Life Sciences, a company based in India, has obtained the European CE mark of approval for its Myval transcatheter aortic heart valve. This marks the first such approval for an Indian company, highlighting how far the country’s medical device industry has advanced in the past few years. The Myval features a hybrid honey comb […]
GORE CARDIOFORM Approved by FDA to Treat Atrial Septal Defects
The GORE CARDIOFORM Septal Occluder has been approved by the FDA to treat ostium secundum atrial septal defects (ASD) via percutaneous closure procedures. In a clinical study of the device in 125 patients with ASD, ranging in age from 2 to 84, all who successfully received the implant maintained the closure when evaluated six months […]
Nexus Ultrasonic Surgical Platform from Misonix FDA Cleared
Mixonix, a Farmingdale, New York company that specializes in ultrasonic devices for surgical applications such as osteotomies and debridements, won FDA clearance for the new Nexus surgical platform. The Nexus combines the capabilities of Mixonix’s three existing products, namely BoneScalpel, SonicOne and Sonastar, into a single system that ca (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 […]
New Device Monitors Blood Flow Through Radial Artery to Prevent Occlusions Post PCI
Following transradial percutaneous coronary interventions (PCI), the radial artery can occasionally occlude, potentially resulting in serious complications. Radial occlusion is treated by applying compression, but clinicians have no idea whether nor how much blood is flowing through the artery. Moreover, once an occlusion happens in the radial arte (Read more...)
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...)
Impella CP with SmartAssist: A Newly FDA Approved Heart Pump with Optical Positioning Sensor
Abiomed, the maker of popular left ventricular assist devices, is releasing its newly FDA approved Impella CP with SmartAssist device. The pump features an optical sensor that physicians can use to position and reposition the device without relying on a cath lab, X-ray, or ultrasound imaging. The sensor can be used either during initial implantatio (Read more...)
Medtronic Unveils Telescope Guide Extension Catheter for Delivery of Coronary Tools
Medtronic announced that it’s releasing its new Telescope Guide Extension Catheter, a device that helps to support coronary interventional instruments and extends access to difficult to reach lesions. The Telescope GEC already has regulatory clearances in the United States and European Union. The device features a solid, round pushwire with a (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...)
Tempo Lead Temporary Heart Trans-Surgical Pacing Lead Cleared in EU
BioTrace Medical, a small company headquartered in Menlo Park, California, announced that its Tempo Lead temporary intracardiac pacing lead has been cleared in Europe under the CE Mark. The device is intended for cardiac procedures that require external pacing, such as during transcatheter valve replacements, and it is the only active fixation temp (Read more...)
SentreHEART Wins EU Clearances for LARIAT LAA Closure System
SentreHEART, based in Silicon Valley, won the European CE mark for its LARIAT-RS 50mm percutaneous left atrial appendage (LAA) closure device. The LARIAT-RS is currently the only product available in Europe that is not an implant, but really a procedure, to fully and permanently close the LAA. In addition to the LARIAT-RS 50 mm being […]
VivaQuant RX-1 Wearable All-in-One Mobile Cardiac Telemetry Unit and Event Monitor FDA Cleared
VivaQuant, a company based in the Minneapolis/St. Paul area, won FDA clearance for its RX-1 cardiac patient monitor. The device is unique in that it is able to operate as a Mobile Cardiac Telemetry unit or Event Monitor, all while transmitting its readings for remote analysis. The system gives cardiologists the ability to free up […]
Surgical Robot Autonomously Navigates Inside Heart
Transcatheter heart surgeries, particularly to repair failing valves, are now common in many high-end hospitals. Though the actual replacement procedure is not easy, navigating to the valve site through narrow vasculature and inside the heart is in itself a challenging task. Moreover, pushing guidewires and catheters through the vessels requires fl (Read more...)
XVIVO Perfusion System for Donor Lung Preservation and Assessment Finally Approved by FDA
XVIVO Perfusion, a company based out in Göteborg, Sweden, has been approved to introduce its Xvivo Perfusion System in the United States to effectively renew lungs that would otherwise would not be good enough for transplantation. The system ventilates, oxygenates, and pumps the Steen Solution Perfusate, a buffered extracellular solution, thro (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...)
LOTUS Edge, a Repositionable Transcatheter Aortic Valve, Approved in U.S.
Boston Scientific won FDA approval for its LOTUS Edge Aortic Valve System for transcatheter valve replacements. It’s indicated for people with severe aortic stenosis who are poor candidates for open heart surgery, but as is the case these days with other transcatheter heart valves, it’s bound to be heavily used off-label. Unlike other t (Read more...)