U.S. health regulators have warned that a resorbable, drug-eluting heart stent developed by Abbott Vascular, Inc. is associated with a higher risk of cardiovascular events and blood clots. Filing a heart stent lawsuit may enable those who suffered complications allegedly related to the Absorb G1 BVS System to obtain compensation for medical bills and other damages.
The medical device attorneys at Bernstein Liebhard LLP are investigating injuries and complications allegedly caused by the Absorb G1 BVS System. To learn if you qualify to file a heart stent lawsuit, contact our firm today by calling (888) 994-5118.
Heart stents are used in patients suffering from coronary artery disease, a condition that occurs when arteries become narrow due to the build-up of plaque. Stents are inserted during cardiac angioplasty to hold the narrowed vessel open.
Heart stents are usually manufactured from metal:
The Absorb G1 BVS Stent was the first and only fully dissolving, drug-eluting stent ever approved to treat patients with coronary artery disease.
The Absorb BVS system is made from drug covered, biodegradable polymer covered in a drug that is designed to be resorbed into the body over time. Once resorbed, the only remaining trace of the heart stent are small platinum markers that help doctors identify where the device was placed.
The Absorb G1 BVS System was approved by the U.S. Food & Drug Administration (FDA) in July 2016 on the basis of a single clinical trial called Absorb III. However, the agency required Abbott Vascular to continue to follow patients enrolled in that study for an additional five years as a condition of the stent’s approval.
Less than a year after it was cleared by the FDA, however, Abbott stopped selling Absorb BVS stents, ostensibly due to slow sales.
Abbott’s decision to end sales of the Absorb G1 BVS System came several months after the FDA announced it was investigating the heart stents due to interim data from the ABSORB III trial that suggested the devices were associated with a higher risk of life-threatening complications, including:
In a Letter to Healthcare Providers issued in March 2017, the FDA noted interim results of the ABSORB III clinical trial showed an 11% rate of major adverse cardiac events, including cardiac death, heart attack, or the need for an additional procedure to re-open the treated heart vessel in patients treated with the Absorb BVS System at two years compared with 7.9% in patients treated with a standard drug-eluting metal stent called XIENCE.
This study also showed a 1.9% rate of developing blood clots (thrombosis) within the BVS versus 0.8% within the XIENCE stent at 2 years, especially when the device was placed in small heart vessels.
A month after Abbott stopped selling Absorb stents, the FDA warned in a second letter that three-year results from the ABSORB III trial continued to show an increased rate of major adverse cardiac events and blood clots in patients receiving the Absorb GT1 BVS compared to the XIENCE heart stent.
Despite these concerns, Abbot has not announced a heart stent recall for the Absorb G1 BVS System. In fact, the company has told physicians that they may continue to use their remaining stent inventory if they choose to do so.
The heart stent lawyers at the nationwide law firm of Bernstein Liebhard LLP are offering free legal reviews to anyone who may have been harmed by the Absorb GT1 BVS System.
If you or a loved one suffered life-threatening cardiovascular events or blood clots following implication of this product, you may be entitled to compensation for:
For a free, no-obligation of your potential heart stent lawsuit, please call (888) 994-5118.
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