Dissolving Heart Stent Clinical Data “Worrisome”

An Abbott stent lawsuit may be a possibility following data suggesting an increased risk of adverse event in patients who have received the Abbott Absorb bioresorbable stent versus other types of stents. Although the advanced stent may offer many advantages over existing treatment modalities, affected patients and their families may be eligible to pursue claims with the assistance of an Abbott Absorb Stent lawsuit attorney.

For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Abbott stent lawsuit attorney who can assist you throughout the legal process.

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Study Suggests Higher Risk of Adverse Events

In July 2016, the manufacturer of the Absorb bioresorbable heart stent, Abbott, announced that the U.S. Food and Drug Administration (FDA) had approved the company’s device, making it the only fully dissolving stent approved for the treatment of coronary heart disease. Heralded by both physicians and patients, the material dissolves and disappears in approximately three years, once the stent has treated the blockage within the walls of the artery.

However, according to an article in Cardio Brief, current data that led to the FDA’s approval suggests that the device, in its current form, may not deliver any advantage to patients. Although the device met the criteria needed for noninferiority in its major clinical trial, the risk of stent thrombosis was reportedly twice as high as traditional metal stents. In addition to an increased risk of thrombosis, implant procedures involving the Absorb stent are considered technically more difficult and may require more imaging and lesion preparation, making the procedure more expensive, the website reported.

“Worrisome” Three-Year Data

In October 2016, TCTMD reported in what it considered to be “worrisome” three-year data from the ABSORB II trial, a time point which, according to the article, “the Absorb GT1 bioresorbable vascular scaffold should be degraded,” but “did not result in an improvement in vasomotor tone and was associated with an increase in late lumen loss” when compared to another type of stent. TCTMD also noted “a two-fold increased risk of device-oriented clinical events,” and quoted medical providers as saying they “taken aback” and “surprised and disappointed” by the data.

TCTMD noted that Abbott claimed the adverse outcomes were “related to problems with operator technique,” and quoted another provider as stating that “it remains to be seen whether the adverse safety signal is a real finding.”

Update: FDA Investigating Increased Rate of Major Adverse Cardiac Events

On March 18, 2017, the FDA informed health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events in patients receiving the scaffold when compared to patients who were treated with the XIENCE drug-eluting stent. According to the FDA’s safety alert, data compiled over a two-year period shows an 11 percent increase in the 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 BVS at two years, compared to 7.9 percent in patients treated with Abbott Vascular’s metallic XIENCE drug-eluting stent. The clinical study also demonstrated a 1.9 percent rate of developing blood clots within the BVS compared to 0.8 percent within the XIENCE stent at two years.

The FDA is working with Abbott Vascular, Inc. to analyze and further understand the potential causes of the higher cardiac event and blood clot rates and plan to continue to monitor the performance of the BVS in other clinical studies and MedWatch reports. The agency recommends that health care providers avoid using the BVS in smaller heart vessels, advise patients experiencing any new cardiac symptoms to seek medical care, and report any adverse events related to the BVS to the FDA’s reporting program, MedWatch.

How an Abbott Stent Lawsuit Attorney Can Help

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result. If the makers of the Absorb stent fail to meet its duty, an Abbott stent lawsuit could result.

People injured by a defective Abbott heart stent may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group. You can fill out the form on this page or contact us by phone or email. If you choose to pursue a claim, we can connect you with an Abbott stent lawsuit attorney who can assist you through the legal process.

After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.