Abbott Laboratories (ABT, Financial) has released some encouraging early results from a global study involving its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system.
Tendyne leads to a meaningful reduction in the symptoms of mitral regurgitation (MR) as well as low rates of death. The study involved the biggest trial related to a transcatheter mitral valve replacement device, Abbott officials said. The study included 100 European patients. The results were achieved 30 days after implantation.
The findings were released at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions’ (EAPCI) in Paris.
The TMVR system is a repositionable and fully retrievable mitral replacement valve. Therefore, Tendyne is unique. Abbott Lab’s TMVR will improve outcomes because it allows for the replacement of the native mitral valve in heart disease patients without the need for an open-heart surgery. It will reduce symptoms of heart failure.
According to the study's results, heart disease patients implanted with the TMVR experienced a drop in the mitral regurgitation (MR) grade to either zero or some traces. Before implantion with Abbott Lab's Tendyne, the MR grade was 3 plus (severe or almost severe) in 99% of heart patients. Compared to a predicted rate for surgical valve replacement of 7.9%, the rate of either serious adverse events or death was 6%.
Mitral regurgitation (MR) or mitral insufficiency (MI) is a heart disorder that occurs when the blood abnormally regurgitates into the heart’s left atrium from the left ventricle while the cardiac muscle is pumping blood. The disease is debilitating for the patient. If not treated, it is life-threatening. The clinical condition can bring an increased risk of arrhythmia, ictus and severe failure of the heart to function properly.
It is very difficult to a make a MR diagnosis. According to worldwide clinical literature there is a nearly 10% rate for moderate to severe MR for people older than 75.
Michael Dale is the vice president of structural heart business at Abbott Labs. He commented: "Tendyne was specifically designed to address the functional, degenerative and mixed causes of mitral regurgitation that cannot be addressed through minimally invasive valve repair or open-heart surgery"
Dale added: "As leaders in transcatheter mitral valve repair, we look forward to advancing another minimally invasive treatment option with unique benefits for people with complex structural heart conditions in need of mitral valve replacement."
Abbott thinks that for first heart disease patient’s enlisting in the U.S. the pivotal trial is just a matter of a few months.
Abbott trades around $61.84 per share on the New York Stock Exchange, versus a 52-week range of $43.40 to $64.60 per share. The stock is up 5% so far this year and has a market capitalization of $108.42 billion:
The stock in Abbott Labs has a price-book ratio of 3.45 times versus an industry median of 3.06 times and a price-sales ratio of 3.82 times versus an industry median of 3.15 times. The price-earnings ratio is 247.36 times towards an industry median of 30.17 times.
The forward dividend is $1.12 per share for a yield of 1.88%.
(Disclosure: I have no positions in Abbott Laboratories.)
