Abbott’s Amplatzer Device Affirms Reduced Recurrent Stroke Rates
On September 14, 2017, Abbott Laboratories (ABT) announced that its landmark clinical trial results show that the Amplatzer PFO (patent foramen ovale) Occluder device reduces the risk of ischemic stroke recurrence by 45.0% compared to alternative medications and therapies.
The PFO is a small opening between the upper left and right chambers of the heart, present at birth. However, the opening should close after birth, which doesn’t happen in about 25.0% of the population. These people are prone to dangerous blood clots that travel to the brain and can cause a stroke. People with PFO are at risk of recurrent strokes.
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The Amplatzer PFO Occluder device was added to Abbott’s product pipeline when it integrated with St. Jude Medical. Abbott has established itself as one of the leading players in the cardiovascular device market and has effectively executed on its key strategic priorities, including the effective integration of Abbott and St. Jude Medical, as shown in the above diagram.
Abbott’s Amplatzer PFO Occluder was approved by the FDA (U.S. Food & Drug Administration) in October 2016. It’s used to treat people with PFO to reduce the risk of ischemic stroke. The surgery takes less than an hour, and the patient is released within 24 hours. It is the first and only such device approved by the FDA to treat PFO patients in order to reduce the risk of cryptogenic ischemic stroke. Medtronic (MDT), Johnson & Johnson (JNJ), and Stryker (SYK) are some of the medical technology companies that provide treatment therapies for ischemic stroke patients.
The study included 980 patients between the ages of 18 and 60 at 69 centers in the United States and Canada. The median follow-up period was around six years. The study results showed that “AMPLATZER PFO Occluder reduced the risk for recurrent ischemic stroke by 45 percent versus medication alone (p=0.046). Additionally, the device showed a 62 percent reduction in risk for recurrent ischemic stroke of unknown cause, known as cryptogenic stroke (p=0.007). The prevalence of PFO in patients who have cryptogenic stroke is 25 to nearly 50 percent.”
Patients treated with the Amplatzer PFO Occluder were found to have a low risk of complications related to the device or procedure compared to those administered with alternative medications. However, the serious adverse events were found to be comparable between the two groups.
ABT stock fell 0.54% on September 14, 2017. The Vanguard S&P 500 ETF (VOO) also fell that same day. VOO has ~0.42% of its total holdings in ABT.