The Acorn Saga Continues
Acorn Cardiovascular and Paracor Medical are frequently compared with one another because they are taking similar approaches to treating heart failure. Acorn has gone through a series of setbacks that have slowed its product development, but it's hoping that this third time is the charm. The company reached agreement with the FDA to embark on a 50-patient clinical trial that Acorn hopes leads to agency clearance of its CorCap device. (This is a sidebar to the article, "Paracor: Can a Mechanical Device Treat Heart Failure?")
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BioVentrix Inc. is developing a unique, minimally invasive approach to reshaping the heart’s scarred and enlarged left ventricle aimed at patients who develop ischemic heart failure following a heart attack. The company has made considerable headway with its technology, which offers an interesting balance between a catheter-based and surgical-based procedure; however, CEO Kenneth Miller, well aware of the pitfalls that have plagued earlier companies in this field, is taking a cautious approach to the US market.
The whole area of congestive heart failure (CHF) is hot right now, particularly for medical device firms who can offer an alternative to drug therapies, which seem to have hit a wall in advancing treatment options. But Acorn Cardiovasculaar, whose device represents a surgery-based approach to reducing the size of enlarged hearts, faces a crowded device field: not only are left ventricular assist device (LVAD) manufacturers seeking to expand beyond their historic bridge-to-transplant niche, but cardiac rhythm management companies are aggressively promoting their new cardiac resynchronization therapy. Adding to Acorn's challenge: the company has had to extend its commercialization timelines as enrollment in its clinical trial took longer than company officials thought it would and it has spent considerable time building the clinical rationale for its approach. As it prepares to launch its device in the next year or so, Acorn is counting on one edge over other CHF device companies: the growing enthusiasm of surgeons for new procedures, as interventional cardiology takes over more and more of their traditional CABGs.
The US FDA has published a raft of guidances on ANDA submissions and labeling updates as well as information requests and discipline review letters.