Analysts believe that device makers who are able to launch implantable products whose functioning isn’t hampered by magnetic resonance imaging will win as chronically ill patients are often directed by their physicians to undergo MRIs.
The problem thus far had been that MRI would be risky in patients with such devices because it would interact with them and impede their proper functioning. As a result, cardiac device makers have been slowly launching MR-conditional devices.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Medtronic announced Wednesday that it has become the first to win approval from the FDA on several MR-conditional quadripolar cardiac resynchronization therapy pacemakers. The Dublin company expects to launch the Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, and Solara Quad CRT-P MRI SureScan in early summer 2017 in the U.S per a news release. Quadripolar pacing technology, which is not exclusive to Medtronic, allows pacing to occur in multiple points using a quadripolar lead compared to the more conventional biventricular pacing.
“These new pacemakers allow clinicians to provide more personalized therapy treatment options,” said Dr. Anne B. Curtis, chair of the Department of Medicine, University at Buffalo, New York, in a Medtronic news release. “Their ability to automatically adjust pacing to meet the patient’s needs, even those who are among the most difficult to treat, is an example of how advanced implanted heart device technology has become.”
Aside from these MR-conditional pacemakers CRT pacemakers, Medtronic has its Advisa MRI and Revo MRI pacemakers that are MR compatible as well as the Evera implantable cardioverter defibrillator (ICD) that can be safely used under MRI.
While Medtronic becomes the first to have such MR-Conditional labeling on the CRT-devices in the U.S., Boston Scientific has similar labeling on its competing devices, but only in Europe. That launch announcement took place in February.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
St. Jude Medical (now part of Abbott Laboratories) had suffered for being late into the MRI-compatible game. In April 2016, then CEO Michael Rousseau announced that the company expected FDA approval of its Assurity MRI-compatible pacemaker in the latter part of 2016.
Sales of the long-awaited Assurity began in February when the company received the approval.
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