The FDA has given approval to Cook Medical‘s Zenith Dissection Endovascular Stent for treatment of symptomatic aortic dissection distal to the left subclavian artery. It is intended to be used along with the company’s Zenith TX2 Dissection Endovascular Graft with Pro-Form Straight Component or Tapered Component Zenith Dissection relies on the Z-Trak Plus Introduction System for delivery and […]
Tag: Cardiac Surgery
More Patients Can Now Be Treated With New SAPIEN 3 Ultra Transcatheter Aortic Valve
Edwards Lifesciences received FDA approval to introduce its SAPIEN 3 Ultra transcatheter aortic heart valve in the U.S. Specifically, the device is indicated for cases of severe, symptomatic aortic stenosis identified to be at intermediate or greater risk of open-heart surgery. The SAPIEN 3 Ultra has some modifications that make it appropriate to a wider range of […]
Argos Cardiac Output Monitor Now Available in U.S.
Retia Medical, out of Valhalla, New York, won FDA clearance and is making available in the U.S. its Argos Cardiac Output Monitor. For use in the OR and ICU, the product uses the company’s MBA algorithm to track both fluid and pressor resuscitation with high precision. This gives clinicians the ability to monitor oxygen delivery and […]
Edwards SAPIEN 3 Ultra Transcatheter Valve for Severe Aortic Stenosis Cleared in Europe
Edwards Lifesciences received European CE Mark approval for its SAPIEN 3 Ultra transcatheter aortic heart valve. Indicated for valve replacement in patients with severe, symptomatic aortic stenosis, the device is available in three sizes (20 mm, 23 mm, and 26 mm) to fit most anatomies. It sports modifications to the valve itself, as well as an […]
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, […]
Tiny New Pacemaker Small Enough for Infants
Researchers at Children’s National Health System, working with engineers from Medtronic, have created a pacemaker appropriately tiny enough to implant into infants. Measuring only one cubic centimeter, about the size of a large pill, it allows the device to be implanted inside the child in a minimally invasive fashion. Currently, because of their size, pacemakers implanted […]
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 […]
Masimo’s High Accuracy RD SET Pulse Oximeters Cleared by FDA
Masimo won FDA clearance for its RD SET sensors that feature the company’s “Measure-through Motion” and “Low Perfusion SET” pulse oximetry. The new disposable oximeters are supposedly twice as accurate than Masimo’s previous offerings for patients over 3 kg, having an accuracy spec of 1.5% at 1 standard deviation, compared to 3% before. The devices […]
HoloLens Used to Looks at Heart Scars in High Resolution
At the Beth Israel Deaconess Medical Center in Boston, researchers have been investigating the use of the Microsoft HoloLens augmented reality headset for visualizing myocardial scars during surgical interventions. During ablations and other electrophysiology procedures, the surgeon must have a good idea of where scars and other relevant items are within the heart. Typically, this […]
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 […]
HeartMate 3 Heart Pump Approved for Patients Not Eligible for Transplant
Abbott‘s HeartMate 3 left ventricular assist device (LVAD) won FDA approval to be used as a destination therapy for advanced heart failure patients who are not eligible for a transplant. Previously, the device has been indicated for patients eligible for and waiting for a transplant. Since transplant hearts are rarely available and not all patients […]
TSP Crosser for Transseptal Puncture and Left Atrial Navigation Cleared by FDA
Transseptal Solutions, a firm based in Israel, has been given clearance to introduce its flagship TSP Crosser Transseptal Access System in the U.S. The device is used to provide a path and to deliver catheters into the left atrium of the heart. Most minimally invasive cardiology procedures have been performed on the right side of […]
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 […]
Boston Sci’s ACURATE neo2 Aortic Valve Showing High Performance
Boston Scientific is touting results of a clinical study evaluating its ACURATE neo2 prosthetic aortic valve system. The implant and delivery system, which are not yet available for sale, had “a high procedural success rate and a low rate of paravalvular aortic regurgitation,” which is blood leaking around the valve, a month after implantation, according to […]
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 endovascular aortic repair (EVAR) procedural requirements – a […]
Two New Advanced Cardiovascular Ultrasounds Debuted by Philips
Philips is releasing two new cardiovascular ultrasound systems that feature similar capabilities, but one is designed for the office while the other is geared for the cath lab. The company says that the new systems have improved image quality and a variety of features that improve usability. The EPIQ CVx, intended for the office, lets […]
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 […]