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...)
Tag: Cardiac Surgery
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...)
LIFEPAK CR2 Defibrillator Reads ECG During Chest Compressions, FDA Approved
Stryker won FDA approval to introduce its LIFEPAK CR2 defibrillator with LIFELINKcentral program manager. It was developed by Physio Control, now a subsidiary of Stryker. The interesting capability of this automatic external defibrillator (AED) is that it is able to analyze the stricken patient’s electrocardiogram (ECG) while someone is perfo (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...)
BIOTRONIK Releases Carnelian Support Catheter to Help Treat Difficult Peripheral Lesions
Calcified and tortuous peripheral vasculature can be very difficult to get instruments into, even before therapy can be administered. BIOTRONIK is releasing a new device specifically designed for exchange and support of guidewires within the peripheral vessels, which the company claims will allow physicians to access sites that were otherwise (Read more...)
Maquet PowerLED II Smart Surgical Lights Coming to America
Getinge has announced that its Maquet PowerLED II surgical lights are now available for purchase in the United States. The devices are applicable to general, as well as hybrid operating rooms, offering features that help illuminate all sorts of procedures. The lights are powered by high-end LEDs, which can be tuned to deliver light of […]
FDA Approves First New Therapy to Treat Heart Attacks in Years
Heart attacks are typically treated by placing stents at the sites of narrowing coronary arteries. This has become a standard of care and advances in cath lab technologies allows interventional cardiologists to accurately place stents in a matter of minutes. Now another option, called SuperSaturated Oxygen (SSO2), is being made available thank (Read more...)
FluoroShield Reduces Radiation Exposure from Fluoroscopes, Gets FDA Clearance
Radiation reduction continues to be an important goal in electrophysiology labs, cath labs, and other interventional rooms. To advance this mission, the FDA just gave clearance to Omega Medical Imaging, a company out of Sanford, Florida, for its FluoroShield radiation exposure reduction system. The FluoroShield uses a very fast collimator coupled w (Read more...)
Nanocomposite Heart Valve to Replace Animal-Derived Devices
Researchers at the University of British Columbia (UBC) have developed a nanocomposite biomaterial heart valve that could provide an alternative to the animal valves that are currently used as heart valve replacements. Moreover, the nanocomposite valves can be delivered to the heart through a transcatheter, allowing for minimally invasive placement (Read more...)
Quantra QPlus System for Rapid Coagulation Analysis Wins FDA de novo Approval
HemoSonics, based in Charlottesville, Virginia, won FDA de novo approval for its Quantra QPlus System and accompanying QPlus cartridge for point-of-care coagulation analysis. The system provides easy and rapid coagulation status, requiring only about a minute of labor from clinicians for each test. Initial results are available in about five m (Read more...)
Phillips Azurion with FlexArm for Enhanced Image-Guided Therapy: Interview with Dr. Barry Katzen of Miami Cardiac and Vascular Institute
Phillips recently announced the release of an enhancement to its Azurion imaging system – the FlexArm. Developed in partnership with the Miami Cardiac & Vascular Institute, the technology allows a clinician to image a patient from every possible angle without having to move the patient or table. Given the proliferation of minimally invasi (Read more...)
First of Its Kind: Early Bird Internal Bleeding Detector Approved by FDA
Though generally safer than open surgeries, minimally invasive vascular procedures have a number of possible complications. One major complication is an internal bleeding or blood extravasation from a ruptured or dissected vessel, typically caused when working with large instruments and devices, and something that a physician may not even notice un (Read more...)
ARTIS icono Biplane Angiography System Unveiled by Siemens Healthineers
Siemens Healthineers has unveiled its ARTIS icono biplane angiography system at the 2019 European Congress of Radiology in Vienna, Austria. The system is particularly suited for neuroradiology procedures, such as removing stroke-causing blood clots, thanks to improved 2D and 3D imaging that can also lower the amount of radiation delivered (Read more...)
Ascyrus Medical Dissection Stent for Repair of Torn Aortas Cleared in Europe
Operative repairs of emergency type A aortic dissections require serious surgical skills and a complicated decision making process. Ascyrus Medical, a company based out of Boca Raton, Florida, just won the European CE Mark to introduce its stenting system that works as an adjunct to the current surgical repair. According to the company, its Ascyrus (Read more...)
Man Receives World’s First Wirelessly Powered Heart Pump
Heart pumps are electromechanical devices that have all kinds of limitations placed on them. One of those is that the pumps needs quite a bit of energy to augment blood output, so a power cable protruding through the skin has always been a necessity. This point of entry is prone to becoming infected, the patient […]
Man Receives World’s First Wirelessly Powered Heart Pump
Heart pumps are electromechanical devices that have all kinds of limitations placed on them. One of those is that the pumps needs quite a bit of energy to augment blood output, so a power cable protruding through the skin has always been a necessity. This point of entry is prone to becoming infected, the patient […]
Heart Implant Measures Left Atrial Pressure to Monitor Heart Failure
Vectorious Medical Technologies, a company based in Israel, has announced that it has developed an unusual intra-cardiac monitoring device that has a built-in microchip but no battery. The V-LAP monitoring device allows patients to take measurements of the left atrial pressure at any time, which is done with the assistance of a small external (Read more...)
Miniaturized Inhaled Nitric Oxide Delivery Units for Use in a Doctor’s Office
Nu-Med Plus, a medtech firm based in Utah, has developed a range of smart delivery devices for inhaled nitric oxide delivery, including a miniaturized unit that can operate in a doctor’s office. The innovation has been possible as parts of the drug patent for nitric oxide have been invalidated, meaning that the cost of the […]
Computational Model of Heart’s Mitral Valve to Predict Surgery Outcomes
Mitral valve repairs are complex surgeries that require particular attention to each patient’s unique anatomy, type of regurgitation such as in Carpentier’s classification, and other factors. Recently, transcatheter mitral valve implants have started to become popular, but they’re very difficult to place so as not to obstruct near (Read more...)
Cook Medical’s Zenith Dissection Endovascular Stent for Aortic Tears FDA Approved
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 Dissecti (Read more...)