ABBOTT PARK, Ill. - The U.S. Food and Drug Administration has approved Abbott's Esprit BTK Everolimus Eluting Resorbable Scaffold System, a novel medical device for treating severe peripheral artery disease (PAD) below the knee. The Esprit BTK System, announced today, provides a new treatment option for the 20 million Americans suffering from PAD, particularly those with chronic limb-threatening ischemia (CLTI), a serious form of the condition.
Until now, no stents or drug-coated balloons were approved for below-the-knee applications in the U.S., leaving balloon angioplasty as the standard care. This method, however, often results in poor outcomes, with many patients experiencing re-blockage. The Esprit BTK System aims to improve these outcomes by opening blockages and delivering the drug Everolimus to support vessel healing before the scaffold dissolves over time.
The device, made from material similar to dissolving sutures, is implanted during a minimally invasive procedure. It is designed to provide support for approximately three years, after which it completely dissolves, ideally leaving the vessel strong enough to stay open on its own.
Dr. Sahil A. Parikh, from Columbia University Irving Medical Center and one of the principal investigators of the LIFE-BTK trial, stated that the FDA's approval of the Esprit BTK System represents a significant advancement in the treatment of PAD below the knee.
The LIFE-BTK trial results, presented in October 2023, showed that the Esprit BTK System reduces disease progression and improves medical outcomes compared to balloon angioplasty. CLTI is characterized by clogged arteries that limit blood flow and oxygen to the lower leg and foot, leading to extreme pain, non-healing wounds, and sometimes amputation. It has a lower five-year survival rate than several common cancers.
Julie Tyler, senior vice president of Abbott's vascular business, emphasized the company's commitment to addressing the significant burden of PAD with innovative treatments like the Esprit BTK System.
Abbott, a global healthcare leader, offers a range of technologies across diagnostics, medical devices, nutritionals, and branded generic medicines. The company operates in over 160 countries with a workforce of 114,000 employees.
This news is based on a press release statement from Abbott.
InvestingPro Insights
Abbott Laboratories (NYSE:ABT) has recently seen its Esprit BTK System approved by the FDA, marking a significant milestone for the company and potentially impacting its financial performance. As investors consider Abbott's position in the market, they might find the following InvestingPro Data points and InvestingPro Tips pertinent:
The company boasts a solid market capitalization of $186.58 billion, reflecting its substantial presence in the healthcare industry. Additionally, Abbott has demonstrated a commitment to shareholder returns, having raised its dividend for 10 consecutive years and maintained dividend payments for an impressive 54 consecutive years. This long-term consistency is a testament to the company's financial stability and may be particularly appealing to income-focused investors.
On the valuation front, Abbott trades at a P/E ratio of 33.45, which is on the higher end, indicating that the stock may be priced at a premium compared to its earnings. This high earnings multiple may suggest that investors have high expectations for the company's future growth and profitability. Notably, Abbott is predicted to remain profitable this year, with a solid track record of profitability over the last twelve months.
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