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CMS has reviewed the CardiAMP HeartFailure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. The CardiAMP HeartFailure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers. said Peter Altman , PhD.,
"CMS proposes Medicare and Medicaid coverage for implantable pulmonary artery pressure sensors to manage heartfailure. Final decision to be published on Jan.
FDA granted CardiAMP Cell Therapy a Breakthrough Device Designation for the treatment of ischemic heartfailure. Leslie Miller, MD , trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida and a member of the CardiAMP HeartFailure II Study Executive Steering Committee. “As
Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heartfailure medication alone (2.9%
The DRAIN-HF study will evaluate the Aortix percutaneous mechanical circulatory support (pMCS) technology in patients with acute decompensated heartfailure (ADHF) who are unresponsive to standard medical therapy. I am excited to be able to include the advanced heartfailure patients in the trial," commented Dr. Grafton.
About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy for Ischemic HeartFailure, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response.
Initiatives such as the World Health Organization's "Medication Without Harm" and the Centers for Medicare and Medicaid Services' (CMS) expanded quality measures aim to reduce preventable emergency visits and hospital admissions due to medication-related harm. BMC Med2015;13(74). Page RL 2nd, O'Bryant CL, Cheng D, et al. Circulation.
Study Population includes all patients with an ischemic stroke inpatient admission in 2018 and were continuously enrolled with Medicare FFS for 1 year prior to and following their initial 2018 stroke admission. 1.378]), and heartfailure (1.282 [95%CI, 1.25‐1.315]).ConclusionPatient 1.378]), and heartfailure (1.282 [95%CI, 1.25‐1.315]).ConclusionPatient
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