HeartLight Excalibur Balloon
Paul Laviolette
Paul LaViolette

Executive chairman: Paul LaViolette
Based: Marlborough, Massachusetts
Founded: early 1990s
Company website

The scoop

CardioFocus was set up in the 1990s to develop ways to use laser energy for medical applications. In the early 2000s, the company narrowed its R&D focus to the development of an endoscopic ablation system for atrial fibrillation, after experiments showed pulmonary vein isolation (PVI)—a technique in which heat energy is deliberately applied to the pulmonary vein to cause scar tissue to form—could stop the spread of the errant electrical signals that cause afib.

Last year, the company’s HeartLight Endoscopic Ablation System scored FDA approval for paroxysmal AF after picking up a CE mark in 2009. The “laser balloon” system was the first catheter-based ablation technology on the market with optics that enable the physician to see the pulmonary vein during treatment.

What makes CardioFocus fierce

CardioFocus Executive Chairman Paul LaViolette describes the firm as “a small company taking on a massive medical epidemic,” as afib is the most common type of serious arrhythmia—affecting an estimated 2.7 million Americans—and a leading cause of stroke. The HeartLight system is a universal, compliant balloon technology that conforms the pulmonary vein, allowing for the treatment of any patient, and compared with rival technologies such as radiofrequency (RF) heating, “creates seamless scars that prevent the erratic impulses associated with AF from escaping the veins.”

Almost half of afib patients who are treated with catheter-based ablation techniques return for repeat treatments, so a key aim of CardioFocus and its HeartLight System is to improve that rate and to reduce the subsequent patient reliance on medication. “We have generated clinical data that shows that we are right on track,” says the company, adding that reducing the rate of repeat procedures “has a substantial positive impact on all stakeholders in the healthcare system and helps reduce the cost of care,” says LaViolette.

The technology also simplifies the PVI procedure, lowering treatment times and—potentially—reducing variability from case to case, according to the company. “We also believe consistently low case times and operator performance can increase patient access to care in more centers.” 

What to look for

In September, CardioFocus picked up a CE mark for HeartLight Excalibur, which uses a new balloon and is designed to make the PVI procedure even easier to perform by boosting the responsiveness of the balloon to the user and improving the level of contact with the vein, cutting the procedure time. The first sales of the Excalibur system have already been made in Europe and the company is now looking ahead to U.S. approval.

In the next 12 months, CardioFocus is also expecting to report “very significant development and clinical milestones” with its next-generation system and intends to complete additional fundraising rounds that will “enable the company to achieve positive cash flow.”

“We are focused on becoming the leading treatment for PVI,” says LaViolette, adding, “We intend to do so by further advancing the HeartLight technology and by completing additional cutting-edge clinical trials.”

“With our technology combination, our clinical data, our benefits in ease-of-use and procedure efficiency, our next generation pipeline and the currently unmet needs of this growing patient population, we aspire to be one of the most important treatments for cardiovascular disease over the next five years.”