St. Jude Medical ($STJ) has launched a portable version in Europe and Japan of its system to offer physicians a view from within the heart to enable physicians to make decisions during catheter-based stenting procedures. Dubbed Optis Mobile, the system is expected to offer comparable imaging as compared to the company's already marketed Optis Integrated System.
Both are used in the catheterization lab to aid in minimally invasive percutaneous coronary intervention (PCI) procedures, also known as coronary angioplasties. They each integrate optical coherence tomography (OCT) and angiography co-registration with fractional flow reserve (FFR) technology into one system--but the new portable version is expected to be useful for hospitals with multiple catheterization labs.
"As the interventional cardiology landscape continues to expand, there is a real need for more portable intravascular imaging systems to ensure hospitals with multiple catheterization labs have the right technology available for physicians to make more informed treatment decisions during PCI," said Dr. Nick West of Papworth Hospital in Cambridge, U.K. "The imaging advancements offered with the Optis Mobile System provide the same benefits of the Optis Integrated System, and allow physicians to clearly visualize complex cardiac anatomy and evaluate how to best proceed during PCI."
The news came shortly after St. Jude had its analyst day on Feb. 5.
There, the company updated Wall Street on the status of four acquisitions: heart pump player Thoratec, which it acquired in October for $3.4 billion; chronic pain company Spinal Modulation, which it bought in April for upwards of $175 million; radiofrequency ablation pain company NeuroTherm, which it gained in August 2014 for about $200 million; and CardioMEMS, which it acquired in May 2014 for $435 million. Both of the latter deals were structured as options that were later exercised.
Going forward, the company expects that neuromodulation will be a more significant part of its business--growing from less than 10% of sales into the low- to midteens over the next 5 years, according to Leerink.
On Thoratec, the company said it's on track for a U.S. submission of its HeartMate III in the second half for the bridge-to-transplant (BTT) indication, with an approval possible in 2017. St. Jude said the Thoratec integration is ahead of schedule with higher-than-expected sales.
St. Jude is working toward securing routine reimbursement for CardioMEMS, having submitted in at the end of January for a national coverage determination from the Centers for Medicare and Medicaid Services (CMS). A decision is expected before the end of 2016, but for now it continues to face substantial reimbursement challenges.
- here is the Optis announcement