In a letter sent to healthcare providers, the U.S. Food and Drug Administration (FDA) validates that Abiomed’s Impella RP heart pump is safe and effective for treatment of right heart failure. The letter comes after the FDA examined the results from Abiomed’s 18-month post-approval study (PAS) of 42 Impella RP patients. The data shows a 64 percent survival rate and 90 percent heart recovery for the subgroup of PAS patients who met the enrollment criteria of Impella RP’s premarket clinical studies. That survival rate is, as the FDA writes in its letter, “similar to the premarket clinical study survival rate,” which was 73 percent.
June 12, 2019
News | Cardiovascular Business
Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma addressed the American Medical Association (AMA) Annual Meeting of the House of Delegates, which ran June 8-12 in Chicago. In her remarks, Verma addressed current efforts by the Trump Administration to enact healthcare reform. The following is a transcript of her remarks.
June 11, 2019
News | Heart Valve Technology
June 11, 2019 — Abbott recently announced positive late-breaking data from its TRILUMINATE study of the company's ...
June 11, 2019Sponsored Content
Feature | Information Technology
Providing exceptional cardiovascular care for patients to achieve the best possible outcomes is the number one goal for ...
March 21, 2024
Technology | Structural Heart Occluders
W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the Gore Cardioform ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED Clinical Study, which demonstrated 100 percent closure success at the six-month evaluation in patients with a successful implant.
June 10, 2019
Technology | Virtual and Augmented Reality
Medivis announced that its augmented reality (AR) technology platform for surgical applications, SurgicalAR, has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration (FDA). The New York City-based medical technology company will commence the immediate commercialization of the platform in the United States.
June 10, 2019
News | Cardiac Imaging
The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular research image. Preclinical image submissions came in from most of MR Solutions’ users across the world. The winners, which were presented at the International Society for Magnetic Resonance in Medicine (ISMRM) conference, May 11-16 in Montreal, QC, Canada, were chosen by a panel of leading academics who examined images from magnetic resonance imaging (MRI), positron emission tomography (PET) or computed tomography (CT) – or a combination of imaging modalities.
June 07, 2019Sponsored Content
Feature | Cardiac Imaging
Cardiac positron emission tomography (PET) is growing in popularity among cardiologists because it provides the ability ...
March 05, 2024
News | Cardiac Diagnostics
Active duty Army personnel have worse cardiovascular health compared to people of similar ages in the civilian population, according to new research in Journal of the American Heart Association.
June 06, 2019
Podcast | Radiation Dose Management
A discussion with Nicholas Bevins, Ph.D., vice chair, physics and research, and Jessica Harrington, RCIS. They explain ...
June 06, 2019
BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), introduced a novel method for producing radioisotopes for nuclear medicine and medical imaging technologies such as computed tomography (CT) scan and positron emission tomography-computed tomography (PET-CT).
June 05, 2019Sponsored Content
Blog
When performing radiofrequency (RF) ablation to treat cardiac arrhythmia, medical professionals must balance the safety ...
December 11, 2023
News | Computed Tomography (CT)
The Society of Cardiovascular Computed Tomography (SCCT) will present the 2019 Gold Medal Award to Jonathon Leipsic, M.D., FSCCT, and Gilbert Raff, M.D., FSCCT, at the SCCT 14th Annual Scientific Meeting, July 11 – 14 in Baltimore. The SCCT Gold Medal Award recognizes outstanding leaders who have made landmark contributions to the field of cardiovascular computed tomography and to the society.
June 05, 2019
News | Hypertension
Orchestra BioMed Inc. announced the presentation of two-year clinical data from the European Moderato I study of BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”) for hypertension at the EuroPCR Conference, May 21-24 in Paris, France. Prof. Petr Neužil, M.D., Ph.D., CSc., FESC, head of the department of cardiology of Na Homolce Hospital in Prague, Czech Republic, presented data which showed a strong safety profile of BackBeat CNT and its ability to immediately, substantially and chronically lower blood pressure in patients with persistent hypertension (office BP > 150 mmHg) despite two or more anti-hypertensive medications and an indication for a pacemaker.
June 04, 2019
News | Heart Valve Technology
Royal DSM recently announced a collaboration with Strait Access Technologies (SAT), to develop the world’s first durable and cost-effective transcatheter replacement heart valves with polymeric leaflets.
June 04, 2019Sponsored Content
Case Study | Hemodynamic Monitoring Systems
Change Healthcare Cardiology Hemodynamics is an integrated hemodynamic monitoring system for monitoring vital signs and ...
November 14, 2023
Technology | Angiography
Medis Medical Imaging Systems B.V. has received clearance from the U.S. Food and Drug Administration for its QAangio XA 3D technology (QFR). The technology offers a non-invasive imaging technique for the assessment of the functional significance of coronary lesions without the need for a pressure wire, nor adenosine.
June 04, 2019
News | Congenital Heart
Researchers at University of California San Diego School of Medicine found higher blood pressure and pesticide exposures in children associated with a heightened pesticide spraying period around the Mother’s Day flower harvest. The study, published online in the journal Environmental Research,1 involved boys and girls living near flower crops in Ecuador.
June 03, 2019
News | Vascular Access
Terumo Medical Corp. is recalling the SoloPath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to a potential for the tip to dislodge from the outer rim of the sheath. This may result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
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