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FDA Warnings on Absorb GT1 Bioresorable Vascular Scaffold (BVS)® and Adverse Cardiac Events

FDA Warnings on Absorb GT1 Bioresorable Vascular Scaffold (BVS)® and Adverse Cardiac Events

In March of 2017 and again in October of 2017, the FDA sent letters to healthcare providers warning that an ongoing study involving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS)® indicates an increased rate of major adverse cardiac events and an increased risk of developing blood clots in patients.

WHAT IS THE ABSORB GT1 BVS®?

Abbott Vascular manufactures the Absorb GT1 BVS® medical device. It is the first bio-absorbable (fully dissolvable) stent approved to treat ischemic heart disease. The Absorb GT1 BVS® is designed to improve blood circulation to the heart by unblocking clogged or constricted arteries. The stent or scaffold is surgically implanted during an angioplasty procedure. The stent is designed to completely dissolve over time.

HISTORY OF THE DEVICE

Absorb GT1 BVS® was initially approved by the FDA in July of 2016. As a condition of its approval, the FDA required Abbott to initiate a five year safety study comparing it to the already approved Abbott XIENCE® drug-eluting stent. After nearly three years of the study, the FDA sent safety information letters to the healthcare community. Just prior to the sending of these letters, Abbot decided to stop selling the Absorb GT1 BVS® by publishing the following statement:

“Due to low commercial sales, Abbott will stop selling the first-generation Absorb Bioresorbable Vascular Scaffold. We pioneered bioresorbable technology because we believe it offers patients the possibility of life without permanent metallic implants, and we will continue work on a next generation bioresorbable device. We'll also continue to follow implanted patients in existing Absorb clinical trials to assess long-term outcomes after the scaffold has dissolved.”

Neither Abbott Vascular nor the FDA has issued a recall of the devices in the United States, so these devices may still be used by doctors and hospitals from their inventories if the health-care provider feels that it is in the best interest of their patient.

WARNING SIGNS OF CARDIAC EVENTS

Patients with the Absorb GT1 BVS® should be aware of any new cardiac symptoms and seek medical help. Cardiac symptoms may include:

  • Irregular heartbeat
  • Chest pain or tightness
  • Shortness of breath
  • Shooting pain or numbness in arms or legs
  • Pain in the upper back, neck, jaw or throat

ABSORB GT1 CVS® LAWSUIT

If you or someone you love has suffered a stroke or a heart attack and you believe it may be related to the use of the Absorb GT1®, you should immediately contact an attorney for a free consultation about your potential lawsuit. Brett H. Oppenheimer, with law offices in Louisville, Kentucky, will give you a free consultation to help you understand if you could have a case against the manufacturer of Absorb GT1 CVS®.

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