Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.
Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov.
The primary outcome is freedom from adverse events at 45 days, defined as all-cause mortality, ischemic stroke, systemic thromboembolism, device- or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention. Secondary outcomes include closure success at 45 days, 6 months and a year and major adverse events measured annually out to five years.
Conformal said the first-in-human use of the LAA seal, in a 63-year-old mountain biker with a history of bleeding episodes with anticoagulation drugs, was performed at the New York-Presbyterian/Columbia University Medical Center in New York City by Dr. Robert Sommer. The patient was discharged the day after his successful implantation on dual anti-platelet therapy per the study’s protocol, the company said.
“First-in-human use marks an important milestone for advancing...
Source: Mass Device - Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Featured Conformal Medical Source Type: news
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