Publications by authors named "G P Siskin"
Purpose: To present the results of the Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA) study evaluating safety and effectiveness of Lava Liquid Embolic System, an ethylene vinyl alcohol (EVOH), for peripheral arterial hemorrhage (PAH).
Materials And Methods: LAVA was a pivotal, prospective, multicenter, single-group, centrally adjudicated study of adults with active PAH. Patients received EVOH at 1 of 2 viscosities, administered by experienced physicians.
Rationale: Observations from our clinical practice indicate a notable occurrence of pleural complications post-percutaneous renal cryoablation (PRC).
Objective: To identify the incidence of pleural complications following PRC and potential risk factors associated with post-procedural pleural complications.
Materials And Methods: This was a retrospective cohort analysis of patients undergoing PRC at two tertiary hospital systems between 2016 and 2022.
Background: The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical devices.
Objectives: The purpose of our study was to (1) quantify characteristics of pivotal clinical trials (PCTs) supporting the premarket approval of endovascular medical devices and (2) analyze trends over the last two decades in light of the FDASIA.
Background: Evidence supporting interventional pulmonary embolism (PE) treatment is needed.
Aims: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population.
Methods: FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System.