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October 12, 2020

New Data From ENGAGE Global Registry Data Presented for Medtronic's Endurant EVAR System

October 12, 2020—New data from the ENGAGE real-world, global (outside the United States) postmarket registry evaluating the safety and effectiveness of Medtronic's Endurant stent graft system were presented by Professor Dittmar Bӧckler, MD, on October 6 at the European Society of Vascular Surgery (ESVS) annual meeting, which is being held virtually as ESVS Month on Tuesdays and Thursdays from September 29 to October 22, 2020. Prof. Bӧckler, an ENGAGE study director, is Professor and Chair of the Department of Vascular and Endovascular Surgery at the University of Heidelberg in Heidelberg, Germany.

The outcomes from the registry provide further evidence that aneurysm sac regression is associated with lower rates of all-cause mortality in patients who underwent endovascular aneurysm repair (EVAR). The data also showed that sac regression, not sac stability, should potentially become the new paradigm of EVAR success. These findings were also consistent with the New England and Society for Vascular Surgery Vascular Quality Initiative (VQI) studies on sac behavior as a predictor of mortality, noted Prof. Bӧckler.

Specifically, results from the ENGAGE registry demonstrated that sac regression at 1 year (n = 441) with Endurant is associated with decreased risk of all-cause mortality through 5 years. Additionally, through 5 years, freedom from all-cause mortality among patients whose sac diameter decreased at 1 year (n = 441) was significantly higher (80% vs 71.9%) compared to patients whose sac diameter remained stable at 1 year (n = 462) and compared to subjects whose sac diameter increased at 1 year (62.6% freedom from all-cause mortality; n = 46).

Furthermore, it was found that sac regression with Endurant at 1 year is likely to persist through 5 years and patients have better outcomes. Results also suggested that stable sacs may not be as benign as once thought.

Prof. Bӧckler reported that at 5-year follow-up, 63.8% (n = 470) of patients treated with Endurant demonstrated a sac diameter decrease, whereas 25.1% and 11.1% of patients treated with Endurant demonstrated stable sac and increasing sac diameters, respectively.

Of patients with sac regression at 1 year, 86% continue to have sac regression at 5 years and only 2% have sac increase at 5 years (n = 241). In contrast, of the patients with stable sacs at 1 year, 41% continue to be stable at 5 years and 18% have sac increase at 5 years (n = 213).

In concluding his talk, Prof. Bӧckler noted, “We suggest that follow-up adherence, especially within the first year, should be a high priority in order to achieve early sac regression.”

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October 13, 2020

WaveClear Raises Funding for Development of CaviClear Ultrasound-Generated Cavitation System

October 12, 2020

Enrollment Begins for MedAlliance’s PRISTINE Registry of the Selution SLR Sirolimus-Eluting Balloon