Absorb GT1 BVS Lawsuit
Abbott Vascular’s ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM has been linked to an increased risk of cardiovascular events and blood clots. Filing an Absorb GT1 BVS lawsuit could be an option for those who experienced life-threatening side effects following implantation of this resorbable, drug eluting stent system.
Absorb GT1 BVS Lawsuit Reviews
The nationwide law firm of Bernstein Liebhard LLP is offering free legal evaluations to individuals who may have been harmed by the Absorb GT1 BVS System. You could be eligible to file an Absorb stent lawsuit if you or a loved one suffered any of the following complications following cardiac angioplasty with this device:
- Thrombosis (blood clots)
- Heart attack
- Cardiac arrest
- Need for additional procedure to open blocked vessel
- Cardiac death
To learn more about your available legal options, please contact an Absorb GT1 BVS lawyer by calling (888) 994-5118.
Absorb GT1 BVS Background
The Absorb GT1 BVS System was approved by the U.S. Food & Drug Administration (FDA) in July 2016, and was the first and only fully dissolving stent ever approved to treat patients with coronary artery disease. The device is placed into a narrowed artery during coronary angioplasty and acts as a scaffold to hold the vessel open.
Over time, the Absorb stent emits a drug called everolimus into the surrounding artery to help prevent the vessel from re-narrowing. Over the course of approximately 3 years, the bio-degradable polymer stent is reabsorbed into the body, leaving behind only small platinum markers to aid doctors in identifying where the scaffold was placed.
The FDA approved the Absorb BVS System based on data from a one-year, 2,008-patient clinical trial called ABSORB III. However, the agency stipulated that Abbott Vascular conduct follow-up on trial subjects for another five years.
Absorb GT1 BVS: What’s the Problem?
In March 2017 – less than a year after it was approved by the agency – the FDA announced it was investigating the Absorb GT1 BVS System due to an increased rate of major adverse cardiac events among patients who had received the stent, when compared to others treated with a metallic, drug-eluting stent called XIENCE.
According to an FDA Letter to Healthcare Providers, interim results of the ABSORB III clinical trial showed an 11% rate of major adverse cardiac events (e.g., 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 the XIENCE stent.
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.
The FDA followed up its alert in October 2017, after results from the ABSORB III study through three years continued to show an increased rate of major adverse cardiac events and blood clots in patients receiving the Absorb GT1 BVS, when compared to patients who had received XIENCE.
The month prior, Abbott Vascular announced it was ending global sales of the Absorb BVX and Absorb GT1 BVS. The company maintains that the decision was driven by commercial factors, rather than safety concerns.
Abbot has not issued an Absorb BVS recall and has indicated that physicians may continue to implant their available inventory if they choose to do so.
Why File an Absorb GT1 BVS Lawsuit?
Patients who suffer complications allegedly associated with the Absorb G1 BVS System are likely to incur significant medical bills and other losses. Filing an Absorb GT1 BVS lawsuit could allow these individuals or their surviving family members to recover damages for:
- Medical bills
- Lost wages
- Pain and suffering
- Emotional distress
- Permanent disability
- Loss of consortium
- Wrongful death
- More
To arrange to have your claim evaluated at no charge to you, please contact our Absorb stent lawyers today, by calling (888) 994-5118.
- Abbott Vascular, Inc. (2016) “Absorb GT1 Bioresorbable Vascular Scaffold System: Patient Information Guide” https://www.vascular.abbott/content/dam/bss/divisionalsites/av/docs/Absorb_GT1_Patient_Guide.pdf
- FDA (2016) “Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) System – P150023” https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm509951.htm
- FDA (2017) “FDA Investigating Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) – Letter to Health Care Providers” https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm546808.htm
- FDA (2017) “UPDATE on Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) – Letter to Health Care Providers” https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm582728.htm
- Abbott Vascular (2017) “Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) System” https://www.vascular.abbott/us/products/coronary-intervention/absorb-bioresorbable-scaffold-dissolving-stent.html
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