FDA Warns of CV Event Risk With Absorb BVS

FDA Warns of CV Event Risk With Absorb BVS ISSUE: The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients …

EIN News (press release)

FDA Warns of CV Event Risk With Absorb BVS

WASHINGTON, DC — The FDA is investigating the significant increase in major adverse cardiac events (MACE) seen for the everolimus-eluting bioresorbable vascular scaffold (Absorb BVS, Abbott Vascular) vs everolimus-eluting metal stent (Xience, Abbot …

Medscape

Higher heart risk seen with Abbott dissolving stent after two years: study

WASHINGTON: Patients who received Abbott Laboratories’ novel dissolving vascular stent had a significantly higher rate of serious adverse heart events than those treated with the company’s widely used Xience drug-coated metal stent two years after …

Channel NewsAsia

FDA Warns of Risk of Major Adverse Cardiac Events With Absorb BVS

On the same day ABSORB III 2-year data are being presented at ACC, the agency is raising concerns. By Michael O’Riordan. March 18, 2017. FDA Warns of Risk of Major Adverse Cardiac Events With Absorb BVS. The US Food and Drug Administration …

TCTMD

Data on Absorb Bioresorbable Stent Show Comparable Outcomes to Leading Drug-Eluting Stent Between One and …

WASHINGTON, March 18, 2017 — Abbott today announced that data from the ABSORB III U.S. pivotal trial showed that Absorb, Abbott’s first-of-its-kind dissolving stent, had comparable efficacy and safety results to XIENCE, Abbott’s leading metallic …

satPRnews (press release)

ABSORB III 2-year results suggest optimal techniques may be key

WASHINGTON — At 2 years, the cumulative rate of target lesion failure was higher with a bioresorbable vascular scaffold compared with an everolimus-eluting stent, but the difference was smaller in patients with appropriately sized vessels in the

Healio

ABSORB III: Two-Year Results Show a Higher MACE Rate Compared With Xience

Although the FDA today issued a letter informing doctors of risks with Absorb, investigators believe the 2-year data are actually reassuring. By Michael O’Riordan. March 18, 2017. WASHINGTON, DC—Two-year results from the ABSORB III study presented …

TCTMD

ACC: Absorb Stent Safety Still Called into Question

WASHINGTON — The news keeps getting worse for the Absorb bioabsorbable scaffold stent. While prior results had raised concerns about target lesion failure and stent thrombosis edging the wrong way compared with a conventional drug-eluting metallic …

MedPage Today

FDA Issues Warning for Absorb Stent

The FDA is investigating the Absorb scaffold’s elevated rates of major adverse cardiovascular events and scaffold thrombosis, the agency announced. At the heart of the issue is the 11% rate of major adverse cardiac events with this device at 2 years …

MedPage Today