Interventional cardiology

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.

Hackensack University Medical Center First in U.S. to Perform Cardiovascular Procedures Using Pioneering Impella 5.5 Heart Pump Device

Retrieved on: 
Monday, October 28, 2019
Interventional cardiology, Medical devices, Medicine, Cardiology, Impella, Prosthetics, Hackensack University Medical Center, Hackensack, New Jersey, Geography of New Jersey, Hackensack, Protected percutaneous coronary intervention

HACKENSACK, N.J., Oct. 28, 2019 /PRNewswire/ -- On October 16, 2019, Hackensack Meridian Health's Hackensack University Medical Center performed its first cardiovascular surgery procedures using a new heart pump called the Impella 5.5 with SmartAssist.

Key Points: 
  • HACKENSACK, N.J., Oct. 28, 2019 /PRNewswire/ -- On October 16, 2019, Hackensack Meridian Health's Hackensack University Medical Center performed its first cardiovascular surgery procedures using a new heart pump called the Impella 5.5 with SmartAssist.
  • Hackensack University Medical Center is one of only three hospitals in the country that currently has access to this new technology, and the first hospital in the U.S. to successfully perform procedures using the device.
  • Hackensack University Medical Center is the only hospital in the northeastern U.S. that is participating in this controlled rollout.
  • Hackensack University Medical Center physicians said that the Impella 5.5 was the "best option" to promote each patient's recovery after cardiogenic shock.

Corindus Vascular Robotics, Inc. Stockholders Approve Acquisition by Siemens Healthineers

Retrieved on: 
Friday, October 25, 2019
Surgery, Medical devices, Hospitals, Health, Cardiology, Interventional cardiology, Corindus Vascular Robotics

The Companys stockholders also approved the proposal to approve, on an advisory (non-binding) basis, specified compensation payable to the Companys named executive officers in connection with the merger.

Key Points: 
  • The Companys stockholders also approved the proposal to approve, on an advisory (non-binding) basis, specified compensation payable to the Companys named executive officers in connection with the merger.
  • The parties anticipate that the transaction will close on October 29, 2019, and the parties intend that promptly thereafter Corindus will be delisted from the NYSE American.
  • Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted vascular interventions.
  • The Companys CorPath platform is the first FDA-cleared medical device to bring robotic precision to percutaneous coronary and vascular procedures.

FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure and Early Use of Impella RP Leads to Higher Survival

Retrieved on: 
Saturday, October 26, 2019
Medical devices, FDA, Health, General Health, Cardiology, Biotechnology, Medicine, Medical specialties, Interventional cardiology, Medical devices, Medical technology, Cardiology, Prosthetics, Impella, Abiomed, Rp, Food and Drug Administration, Protected percutaneous coronary intervention, Medical devices, FDA, Health, General Health, Cardiology, Biotechnology, Medicine, Medical specialties, Interventional cardiology, Medical devices, Medical technology, Cardiology, Prosthetics, Impella, Abiomed, Rp, Food and Drug Administration, Protected percutaneous coronary intervention, Medical devices, FDA, Health, General Health, Cardiology, Biotechnology, Medicine, Medical specialties, Interventional cardiology, Medical devices, Medical technology, Cardiology, Prosthetics, Impella, Abiomed, Rp, Food and Drug Administration, Protected percutaneous coronary intervention

The protocol includes recommendations on patient selection and timely identification of right heart failure with subsequent implantation of Impella RP.

Key Points: 
  • The protocol includes recommendations on patient selection and timely identification of right heart failure with subsequent implantation of Impella RP.
  • These results, from the Impella RPs post-approval study, match the survival rate in the Impella RPs pre-approval study.
  • The FDA has confirmed the classification of Impella RP post-approval study patients into two categories: Recover Right protocol and salvage support.
  • Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Impella Connect are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries.

MedHub's AI-powered Solutions Are Disrupting Cardiology

Retrieved on: 
Tuesday, October 22, 2019
Interventional cardiology

The results of the feasibility study will be published at the upcoming, highly prestigious, ICI conference.

Key Points: 
  • The results of the feasibility study will be published at the upcoming, highly prestigious, ICI conference.
  • Moreover, clinically unnecessary interventions, including stent placement procedures, have reached 30%, costing the American healthcare system roughly $4 billion each year.
  • Dr. Koifman is only one of several key people in the cardiology space who are part of the MedHub team.
  • About MedHub, he adds "I believe there is tremendous clinical and economic potential for all stakeholders, including clinicians, patients and payors."

Neovasc Reducer™ for Treatment of Refractory Angina Featured in Sponsored Session at the 40th Annual National Congress of the Italian Society of Interventional Cardiology

Retrieved on: 
Tuesday, October 22, 2019
Interventional cardiology, Cardiovascular system, Angina, Cardiology, Medical specialties, Medicine, Nature Reviews Cardiology

Prof Shmuel Banai, Director, Division of Cardiology Tel-Aviv Medical Center, and Neovasc Medical Director, presented the history and rationale of coronary sinus narrowing for the treatment of angina.

Key Points: 
  • Prof Shmuel Banai, Director, Division of Cardiology Tel-Aviv Medical Center, and Neovasc Medical Director, presented the history and rationale of coronary sinus narrowing for the treatment of angina.
  • In 1952, Dr. Beck became the first to receive the title of professor of cardiovascular surgery in the United States.
  • The clinical cardiologists polled estimate that as many as 12% of their angina patients are refractory to currently available therapies.
  • On behalf of the investigators, Dr. Gianpiero DAmico, University of Padua, presented the Italian Society of Interventional Cardiology (GISE) Multi-Center study on the Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina.

Philips introduces new 200mm and 150mm Stellarex 0.035” low-dose drug-coated balloons to broaden treatment options for peripheral artery disease patients

Retrieved on: 
Tuesday, October 15, 2019
Medical specialties, Medicine, Circulatory system, RTT, Cardiology, Aging-associated diseases, Restenosis, Surgery, Peripheral artery disease, Interventional cardiology, Coronary artery disease, Artery disease

The new balloons broaden physicians treatment options for peripheral artery disease (PAD) patients with a high risk of restenosis and expand the Stellarex portfolio, which has a proven significant treatment effect and high safety profile.

Key Points: 
  • The new balloons broaden physicians treatment options for peripheral artery disease (PAD) patients with a high risk of restenosis and expand the Stellarex portfolio, which has a proven significant treatment effect and high safety profile.
  • The 200mm and 150mm Stellarex 0.035 low-dose DCBs are now available in the U.S. and will be rolled out to other markets in due course.
  • Broadening physicians treatment options helps ensure more PAD patients will receive treatment before the disease progresses.
  • Our integrated solutions advance minimally invasive procedures for patients with coronary artery disease, peripheral artery disease and lead extraction indications.

FDA Classifies Medtronic Sherpa Delivery Catheter Field Action Initiated in March 2019 as Class I Recall

Retrieved on: 
Wednesday, October 9, 2019
Medical technology, Medical devices, Medicine, Medical equipment, Medtronic, Interventional cardiology, Interventional radiology, Coronary stent, Stent, MDT

DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the companys voluntary field action initiated in March 2019 related to the 6F Sherpa NX Active Coronary Guide Catheter as a Class I recall.

Key Points: 
  • DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the companys voluntary field action initiated in March 2019 related to the 6F Sherpa NX Active Coronary Guide Catheter as a Class I recall.
  • This issue does not affect the Medtronic Launcher Coronary Guide Catheter or other Medtronic coronary stents, balloons or implantable devices.
  • Customers using the catheter have been asked to return all affected inventory to Medtronic.
  • Health care professionals can direct questions to their Medtronic Field Representative or Medtronic Customer Service at +1-888-283-7868.

Neovasc and GADA® Sponsor Session at the 40th Annual (GISE) National Congress of the Italian Society of Interventional Cardiology

Retrieved on: 
Wednesday, October 9, 2019
Other Health, General Health, Medical devices, Hospitals, Clinical trials, Cardiology, Biotechnology, Medical Supplies, Health, Interventional cardiology, Cardiology, Angina, Neovasc Inc., GADA Spa

Moderated by Sergio Berti, M.D., and Francesco Giannini, M.D., the session will also include a presentation from Professor Shmuel Banai, M.D., Neovascs Medical Director.

Key Points: 
  • Moderated by Sergio Berti, M.D., and Francesco Giannini, M.D., the session will also include a presentation from Professor Shmuel Banai, M.D., Neovascs Medical Director.
  • The registry has enrolled over 180 patients and is one of the largest studies to date.
  • Additionally, the results of a specialized third-party survey targeting cardiologists and reviewing the clinical path of patients with refractory angina will be discussed.
  • We are proud to organize this symposium together with the Italian Society of Interventional Cardiology (GISE) for the benefit of patients suffering from refractory angina.

PQ Bypass Announces Unconditional IDE Approval From U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2)

Retrieved on: 
Tuesday, October 8, 2019
Research, Medical devices, Clinical trials, Cardiology, Biotechnology, Health, Science, Medicine, Interventional radiology, Medical devices, Medical specialties, Stent, Graft, Health care, Vascular surgery, Interventional cardiology

By acquiring early FDA feedback through the Pre-Submission process, the TORUS-2 study (The PQ Bypass pivOtal IDE intra-aRterial stent graft study for occlUsive and re-Stenotic fem-pop revascularization) is the companys second IDE approved in less than two years and is the first pivotal IDE for an SFA stent graft since Viabahn received initial PMA approval in 2005.

Key Points: 
  • By acquiring early FDA feedback through the Pre-Submission process, the TORUS-2 study (The PQ Bypass pivOtal IDE intra-aRterial stent graft study for occlUsive and re-Stenotic fem-pop revascularization) is the companys second IDE approved in less than two years and is the first pivotal IDE for an SFA stent graft since Viabahn received initial PMA approval in 2005.
  • View the full release here: https://www.businesswire.com/news/home/20191008005368/en/
    The TORUS-2 IDE approval comes close on the heels of the approval for the DETOUR-2 trial.
  • Having been exposed to the TORUS stent graft in the context of the DETOUR procedure, increasing demand is being vocalized to get this same stent graft studied for its safety and efficacy within the SFA as an intra-arterial stent graft.
  • Their physician-driven innovations include the DETOUR Procedure for percutaneous femoral-popliteal bypass and the TORUS stent graft, both currently under investigation in separate global, multicenter, IDE studies.