|St. Jude's Allure Quadra pacemaker--Courtesy of St. Jude|
St. Jude Medical ($STJ) is confronting a flat pacemaker market and continued fallout from faulty defibrillator leads with a rollout of new products in both spaces. The hope: Next-generation improvements will spur new market interest and greater revenue.
The Minnesota device company said it gained FDA approval for its new Allure Quadra cardiac resynchronization therapy pacemaker to treat patients with heart failure and also won regulators' OK to start marketing its Assurity and Endurity pacemaker devices Allure Quadra, which offers quadripolar lead technology, a first in the U.S. The Assurity and Endurity pacemakers are next-generation pacers that are smaller, have a longer shelf life and give early notification of atrial fibrillation-related events. They are also designed to pace in a way to reduce hospitalizations related to heart failure. All three products have had CE marks since March 2013. Their U.S. rollout will commence by the end of the 2014 first quarter.
Separately, St. Jude also triggered the global launch of its new Optisure defibrillation lead, which is based on the company's Durata lead design and part of its Optim defibrillator lead product line.
Optisure's launch comes in the context of a controversial defibrillator history at the company.
St. Jude is dealing with dozens of lawsuits stemming from the 2011 recall of its Riata implantable cardioverter-defibrillator leads after allegations of poor design, dangerous shocks and device breakdowns. With this in mind, St. Jude emphasizes the fact, for example, that Optisure is built with a thicker layer of insulation to resist abrasion (a problem with Riata) and that the product is backed by ample clinical trial data demonstrating its safety and reliability. The insulation is made with silicone rubber and polyurethane in order to make it more flexible and durable, and easier to implant. The new leads are also compatible with the company's ICDs and CRT-Ds.
St. Jude also emphasizes that Optisure, because of its Durata similarities, has a safety profile reinforced by Durata's track record. Durata's safety has been called into question by some, but the company noted that about 11,000 Durata leads are actively monitored through patient registries, and that St. Jude has more than 27,000 patient hours demonstrating Durata's safety and reliability. In other words, St. Jude's marketing arm is doing whatever it can to get the word out that these new leads aren't like the recalled Riata ones.
Optisure has approvals in the U.S., European Union, Canada, Australia, and Japan.
- here's the defibrillator news
- and check out the pacemaker approval announcement