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 (Read more...)
Tag: Cardiac Surgery
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 whi (Read more...)
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 Valia (Read more...)
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 (Read more...)
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 (Read more...)
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 (Read more...)
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 (Read more...)
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 (Read more...)
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 ulc (Read more...)
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 pa (Read more...)
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 techni (Read more...)
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 (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...)
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 […]
Implantable System for Remodulin FDA Approved to Treat Pulmonary Hypertension
Medtronic won FDA approval for its Implantable System for Remodulin (ISR) as a new treatment option for people with pulmonary arterial hypertension. It consists of Medtronic’s Synchromed II drug delivery system, an intravascular catheter, and United Therapeutics‘ Remodulin (treprostinil) Injection medication. Unlike external i (Read more...)
“Ticker” by Mimi Swartz: A Medgadget Book Review and Interview with the Author
Of all the organs in the human body, the heart is arguably the most important, well-known, and worried about. Not only is the heart the vital electro-mechanical pump that moves about 2,000 gallons of our blood every day, but for centuries it’s been symbolic of the seat of emotion, reason, and life itself for many […]
Medtronic’s HVAD Heart Pump FDA Approved for Less Invasive Implantation
Medtronic’s HVAD System, a left ventricular assist device, can now be implanted via a thoracotomy, a less invasive procedure than a median sternotomy. Moreover, a thoracotomy means that future procedures that may require access through the chest can still be performed in what are already risky patients. The HVAD System is indicated (Read more...)