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FDA Issues Safety Alert Involving Abbott Vascular Stent Concerns

Mar 23, 2017
FDA Issues Alert Involving Abbott Vascular Stent Concerns

The U.S. Food and Drug Administration (FDA) issued a safety alert to health care providers on March 18, 2017 who are treating patients with Abbott Vascular's Absorb GT1 Bioresorbable Vascular Scaffold (BVS). The safety alert was triggered by the increased rate of major adverse cardiac events in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE stent.

An 11 percent rate of major adverse cardiac events by the FDA's initial review of two-year data from the BVS pivotal clinical study shows: 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 with a 7.9 rate percent in patients treated with Abbott Vascular's metallic XIENCE drug-eluting stent. This study also shows a 1.9 percent rate of developing blood clots (thrombosis) within the BVS device versus 0.8 percent within the XIENCE stent at two years. When the device was placed in small heart vessels, these higher adverse event rates in BVS patients were more likely to occur.

The FDA is cooperating with Abbott Vascular, Inc., to conduct additional testing to better understand the cause or causes of the higher cardiac event and clot rates in patients treated with BVS compared to the XIENCE stent. The FDA will continue to monitor the performance of the BVS in ongoing clinical studies and in reports submitted to the FDA through MedWatch. This communication will be updated as additional information or data becomes available. The National law firm Parker Waichman LLP has extensive experience and success in medical device litigation. The attorneys at the firm are available to provide information to those who have concerns about Abbott Vascular's Absorb GT1 Bioresorbable Vascular Scaffold (BVS).

What are Cardiac Stents?

What are Cardiac Stents?

Cardiac stents are small, expandable tubes that are implanted to open narrowed arteries. For people with heart disease caused by the buildup of plaque, stents can open narrowed arteries, reduce symptoms, such as chest pain, and help treat a heart attack.

The Absorb was approved by the FDA in 2016 for the treatment of coronary artery disease. When cholesterol deposits accumulate on arterial walls and reduce the blood supply to the heart, the condition is typically treated with a metallic stent to prop an artery open. However, metallic stents are permanent and if scar tissue forms, the artery may once again narrow.

Abbott Vascular's Absorb GT1 Bioresorbable Vascular Scaffold stent supports the artery and slowly releases a drug that reduces inflammation and scar tissue formation. The stent is designed to be gradually reabsorbed once it has helped the artery heal, usually within three years of placement, according to Abbott. Abbott Vascular warns that the Absorb stent should not be used in "very small arteries."

The ABSORB III clinical trial was launched in 2012, four years before the device received FDA clearance. The recommended implantation technique has changed in the intervening time, said Abbott.

FDA Safety Recommendations

In the safety notice, the FDA recommends that health care providers follow the instructions for target heart vessel selection and optimal device implantation that are included in the BVS physician labeling. For example, avoid using the BVS in small heart vessels.

Patients who experience any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath, should seek medical attention. For additional information about risks associated with the BVS, physicians should refer to the BVS physician labeling.

Physicians should advise BVS patients to follow the recommendations for dual antiplatelet therapy (DAPT) as prescribed.

Any adverse events related to the BVS that come to the attention of the physician if he or she suspects a problem with the BVS is encouraged to file a voluntary report to the FDA through MedWarch, the FDA Safety Information and Adverse Event Reporting Program.

In its statement, Abbott aid, "The FDA's letter to healthcare providers emphasized the importance of following instructions for use when implanting Absorb." When "implanted in appropriately sized vessel sizes and following current instructions for use, the results for Absorb are comparable to the leading metallic drug-eluting stent - with the added feature of leaving no metal behind once it dissolves," Abbott wrote.

Help and Advice for Those Harmed by Absorb GT1 Bioresorbable Vascular Scaffold

If you or someone you know has suffered an adverse cardiac event after the implantation of the Absorb GT1 Bioresorbable Vascular Scaffold, the personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For any questions, we urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).


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