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Inari PEERLESS II RCT Will Compare FlowTriever Versus Anticoagulation in PE Patients

May 22, 2023—Inari Medical, Inc. announced the planned enrollment of PEERLESS II, the company’s third randomized controlled trial (RCT) in venous thromboembolism (VTE).

Endovascular Engineering’s Helo Thrombectomy System for PE Studied in ENGULF

November 7, 2023—Endovascular Engineering, Inc. (E2) announced recently that initial results from its ENGULF study demonstrated successful outcomes among the first 15 patients evaluated in the trial using E2’s Helo thrombectomy system for the treatment of acute submassive pulmonary embolism (PE).

Endovascular Engineering’s Helo Thrombectomy System Receives IDE Approval for ENGULF Pivotal Trial to Treat PE

January 11, 2024—Endovascular Engineering (E2), a developer of clot removal technologies for venous thromboembolism, announced FDA approval for an investigational device exemption (IDE) for the ENGULF United States pivotal trial.

Moderate Sedation Shows Promise for TAVR Patients

May 6, 2016—An analysis from the Society for Thoracic Surgeons and the American College of Cardiology transcatheter valve therapy registry, the STS/ACC TVT Registry, demonstrated that moderate sedation use is associated with improved patient outcomes, including lower 30-day mortality and shorter hospital stays, for percutaneous transfemoral transcatheter aortic valve replacement (TAVR) procedures, as compared to traditional general anesthesia. The study was presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 scientific sessions in Orlando, Florida.

Inari Commences PEERLESS II RCT of FlowTriever in Intermediate-Risk PE

November 27, 2023—Inari Medical, Inc. announced that the first patient has been enrolled in the PEERLESS II randomized controlled trial (RCT).

Penn Study of Lariat for LAA Closure Suggests Need for FDA Reassessment of Off-Label Use of Devices

May 4, 2015—The Perelman School of Medicine at the University of Pennsylvania (Penn) announced that investigators published a study finding that the Lariat suture delivery device (SentreHEART, Inc.), which has been cleared by the US Food and Drug Administration (FDA) for soft tissue approximation during surgical procedures, is associated with a significant incidence of death and urgent cardiac surgery during its frequent off-label use for left atrial appendage (LAA) exclusion to prevent stroke in patients with atrial fibrillation.

Endovascular Engineering Helo Thrombectomy System for Acute PE Evaluated in ENGULF Trial

May 3, 2024—Late-breaking data from the ENGULF trial showed that the dual-action Helo pulmonary embolism (PE) thrombectomy system (Endovascular Engineering [E2]) was effective and safe in treating acute PE.

Study Uses PERT Consortium Registry Data to Examine Practice Patterns and Outcomes in High-Risk Pulmonary Embolism

January 17, 2024—In a retrospective analysis using data from the PERT Consortium registry, Kobayashi et al found high rates of in-hospital mortality and major bleeding in patients with high-risk pulmonary embolism (PE) as compared with intermediate-risk PE.