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Abbott's (ABT) DAPT for High Bleeding Risk Gets FDA Approval

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Abbott Laboratories ABT recently announced the receipt of FDA approval for its XIENCE family of stents for one-month (as short as 28 days) DAPT labeling for high bleeding risk (HBR) patients in the United States. In addition, in April 2021, XIENCE stents also received CE Mark approval for one-month DAPT, giving XIENCE stents the shortest DAPT indication in the world.

Abbott continues to focus on further improving the class-leading XIENCE stent platform through innovation supported by clinical data, including HBR, intended to provide best care for patients suffering from coronary heart disease.

More in the News

According to Abbott, usually patients who receive stents are on DAPT regimens, which include aspirin and antiplatelet drugs known as P2Y12 inhibitors to prevent blood clots for six to 12 months. DAPT regimens help support vessel healing and prevent clotting from blocking the stented vessel.

However, during prolonged courses of DAPT, HBR patients may experience side effects like bleeding.

Few Words on XIENCE Skypoint

Abbott has also received FDA nod and European CE Mark approval for its next-generation XIENCE Skypoint stent, in addition to the HBR indication.

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Per Abbott’s management, the newest generation of the XIENCE stent provides multiple improvements that offer improved deliverability and expansion capability, as even small differences between stents can impact both short- and long-term patient outcomes.

Latest FDA Approval

The new labeling approval came on the heels of favorable results of Abbott’s XIENCE 28 and XIENCE 90 studies showing that DAPT can be safely discontinued as early as in 28 days with no increased risk in patient adverse events.

The new FDA approval for DAPT for the XIENCE family of stents offers interventional cardiologists assurance that they are delivering the best care to high bleeding risk patients.

Industry Prospects

Per a report by MARKETSANDMARKETS, the global interventional cardiology devices market size was valued at $13.8 billion in 2020 and is projected to reach $21.2 billion by 2025, at a CAGR of 8.9%.

The expanding geriatric population along with growing prevalence of coronary artery diseases is the main cause behind this rapid growth.

Recent Regulatory Approvals

In June 2021, Abbott announced the receipt of the CE Mark for its Panbio COVID-19 Antigen Self-Test for sale directly to consumers. The test, which delivers results in a few minutes, can be used to detect the SARS-CoV-2 virus on symptomatic or asymptomatic (with or without symptoms) adults and children.

In May 2021, Abbott’s structural heart line has received a major boost with the latest European regulatory approval for the company’s newest-generation transcatheter aortic valve implantation (“TAVI”) system – Navitor. Per the company, with receipt of the CE mark, the minimally-invasive device is now available in Europe to treat people with severe aortic stenosis who are at high or extreme surgical risk.

Price Performance

Shares of the company have gained 26.9% in a year’s time compared with the industry’s rise of 16.6%.

Zacks Rank and Key Picks

Currently, the company carries a Zacks Rank #5 (Strong Sell).

A few better-ranked stocks from the broader medical space are Envista Holdings Corporation NVST, BellRing Brands, Inc. BRBR and IDEXX Laboratories, Inc. IDXX, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Envista Holdings has an estimated long-term earnings growth rate of 26%.

BellRing Brands has an estimated long-term earnings growth rate of 22%.

IDEXX Laboratories has a projected long-term earnings growth rate of 20%.

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