Abbott's AMPLATZER Pivotal Study to Strengthen Vascular Arm
Abbott ABT recently has initiated a U.S. pivotal clinical study to evaluate the safety and effectiveness of a modified version of its AMPLATZER device. This device is designed to correct a common congenital heart defect in pre-term infants. The device is same as the larger sized AMPLATZER Duct Occluder II product. The clinical study will be conducted on 50 patients at up to 10 centers across the United States.
According to Abbott, Patent ductus arteriosus (PDA) is a life-threatening vascular pathway or duct in the heart that remains open due to the failure of the fetal duct to close after birth. In some cases, the PDA fails to close spontaneously in premature babies leading to difficulty in breathing and feeding.
Pharmaceuticals can be used at times to close the duct but are less effective in pre-term infants. Current treatment options for pre-term infants who are not responsive to pharmaceuticals are limited to surgery. However, surgery is not always possible and leaving the duct open can lead to fatal outcomes for infants. Breaking the conventional treatment, Abbott is developing the AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) device to provide physicians with a nonsurgical treatment option for addressing the PDA defect in newborns and pre-term infants. ADO II AS is already approved for use in Europe.
If the study is successful, the U.S. trial results will support Abbott's application for FDA approval for pediatric use in the country.
We note that Abbott has been consistently trying to expand its vascular business under the Medical Device segment that is on solid growth trajectory of late. In the last reported second quarter, the Medical Devices business sales spiked 89.2% on a reported basis.
Also, the recent developments include the receipt of FDA approval for Full MagLev HeartMate 3Left Ventricular Assist System (also known as an LVAD). The HeartMate 3 system enables physicians managing advanced heart failure patients in need of short-term hemodynamic support.
Abbott also announced CE Mark and first use of the new Confirm Rx Insertable Cardiac Monitor (ICM). This is the world's first smartphone-compatible ICM which helps physicians identify difficult-to-detect cardiac arrhythmias, including atrial fibrillation (AF).
According to a report by Markets and Markets, the global pediatric interventional cardiology market is estimated to see a CAGR of 9% from 2013 to 2018. Looking at the bountiful opportunities in this niche space, we believe the company’s latest development by is a strategical fit.
Over the last three months, Abbott has been trading above the broader industry. The stock has till now gained 7.9% as against the industry's decline of 1.2%.
Zacks Rank & Key Picks
Abbott carries a Zacks Rank #3 (Hold). A few better-ranked medical stocks are Edwards Lifesciences Corporation EW, Lantheus Holdings, Inc. LNTH and IDEXX Laboratories, Inc. IDXX. Edwards Lifesciences sports a Zacks Rank #1 (Strong Buy), while Lantheus Holdings and IDEXX Laboratories carry a Zacks Rank #2 (Buy). You cansee the complete list of today’s Zacks #1 Rank stocks here.
Edwards Lifesciences has a long-term expected earnings growth rate of 15.2%. The stock has rallied roughly 19.8% over the last six months.
Lantheus Holdings has a long-term expected earnings growth rate of 12.5%. The stock has gained 21.6% over the last six months.
IDEXX Laboratories has a long-term expected earnings growth rate of 19.8%. The stock has gained around 2.9% over the last six months.
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