GT1 Bioresorbable Vascular Scaffold
The FDA issued a warning about the Absorb GT1 Bioresorbable Vascular Scaffold (BVS). Manufactured by Abbott Vascular, BVS brings an increased rate of major adverse cardiac events compared to other devices on the market.
About GT1 Bioresorbable Vascular Scaffold
In July 2016, The FDA approved the Absorb GT1 Bioresorbable Vascular Scaffold (BVS). It was the first and only fully dissolving stent to treat coronary artery disease. Surgeons use BVS to open coronary arteries blocked by plaque in order to increase blood flow to the heart muscle. Doctors implant BVS during an angioplasty procedure, gradually dissolving until it is fully absorbed by the body over time.
Over time, the BVS 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 body reabsorbs the biodegradable polymer stent. The system leaves behind only small platinum markers to aid doctors in identifying where the scaffold placement.
FDA approval hinged on data from a one-year, 2,008-patient clinical trial, ABSORB III. However, the agency stipulated that Abbott Vascular conduct follow-up on trial subjects for another five years.
BVS ABSORB III Trial
The FDA’s initial review of two-year data from the BVS clinical study (the ABSORB III trial) shows an 11% rate of major adverse cardiac events. These events include cardiac death, heart attack, or additional open heart procedures. This is higher than the already approved Abbott Vascular’s metallic XIENCE drug-eluting stent.
Also in the ABSORB III trial was an almost 2% rate of developing thrombosis. This is nearly double than with the XIENCE stent. This is why the FDA opened a safety investigation. The FDA said patients with coronary stents should take dual antiplatelet therapy. This is a combination of aspirin and Plavix, or a similar blood thinner.
BVS Heart Problem Symptoms
If you have the BVS system and have any heart problem symptoms, you should immediately seek medical attention. Symptoms of heart problems include:
- Chest discomfort – Most heart attacks involve discomfort in the center of the chest that lasts more than a few minutes, or that goes away and comes back. It can feel like uncomfortable pressure, squeezing, fullness or pain.
- Other discomfort – Discomfort can happen in other areas of the upper body. Symptoms can include pain or discomfort in one or both arms, the back, neck, jaw or stomach.
- Shortness of breath
- Cold Sweat
How We Can Help
When you experience side effects, it can have devastating effects on your entire life. In fact, you may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Furthermore, if a person dies from complications, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Also, if a suit finds the conduct of a company in manufacturing and selling a product to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. Case evaluations are free of cost and without obligation. Therefore, call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.