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.

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”