William F. Bernhard

FDA Approves Less Invasive Surgical Approach for Abbott's Heart Pump to Help Patients Avoid Open Heart Surgery

Retrieved on: 
Tuesday, January 7, 2020
Medicine, Medical specialties, Clinical medicine, Interventional cardiology, Cardiology, Medical devices, Prosthetics, Ventricular assist device, Thoracotomy, Thoratec, William F. Bernhard

ABBOTT PARK, Ill., Jan. 7, 2020 /PRNewswire/ -- Abbott (NYSE: ABT)today announced U.S. Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery.

Key Points: 
  • ABBOTT PARK, Ill., Jan. 7, 2020 /PRNewswire/ -- Abbott (NYSE: ABT)today announced U.S. Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery.
  • The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 Left Ventricular Assist Device (LVAD), the industry's leading heart pump.
  • With approval for an alternative surgical technique, Abbott's HeartMate 3 heart pump can now be implanted via lateral thoracotomy a surgical approach where an incision is made between a patient's ribs to access the heart.
  • Physicians believe that for many patients this technique has advantages over open heart surgery because it can result in less bleeding and a shorter recovery time for patients.

Medtronic Receives FDA “Breakthrough Device Designation” for Developing Fully Implantable Heart Pump

Retrieved on: 
Tuesday, October 29, 2019
Medical technology, Medicine, Health, Interventional cardiology, Cardiology, Medical devices, Prosthetics, Ventricular assist device, Medtronic, Food and Drug Administration, William F. Bernhard

DUBLIN, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device (LVAD) for patients with advanced heart failure, currently in development.

Key Points: 
  • DUBLIN, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device (LVAD) for patients with advanced heart failure, currently in development.
  • Currently, LVAD systems include an implanted heart pump to increase the amount of blood that circulates through the body.
  • The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
  • Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.The Medtronic Fully Implantable LVAD is in early-stage research and development, and is not available for sale anywhere in the world.