Apaxis Medical, Inc. (Apaxis) is a Houston-based medical device company developing a set of tools and techniques to make LVAD implantation easily reproducible and less risky by eliminating the need for CPB, leading to an increase in LVAD utilization.
- Apaxis is developing innovative tools that make LVAD implantation less stressful for the patient
- Avoiding operative stress will improve post-operative results after LVAD implantation
- By improving post-operative results, Apaxis will accelerate LVAD adoption and application and grow a $2B LVAD industry
Limitations of current Heart Failure therapies:
According to the American Heart Association, heart failure affects over five million Americans with over 550,000 of them classified as class IV based on the New York Heart Association (NYHA) classification. Published data suggests that these gravely ill class IV patients would benefit from Left Ventricular Assist Device (LVAD) implantation however fewer than 4000 LVADs were implanted in the United States in 2008. This is despite the fact that annual mortality in this population may be as high as 50%.
The low utilization of LVAD technology in 2008 is due in part to the perception that it is a procedure of last resort. This perception has been fueled by poor outcomes in some of the sickest heart failure patients. Currently, many patients in late stage heart failure being referred for LVAD implantation have some element of end-organ dysfunction such as liver, kidney, brain and lung disease. It is well known that cardiopulmonary bypass (CPB), which is generally required for LVAD implantation, can exacerbate end organ dysfunction, resulting in morbidity and even mortality.
A set of tools and techniques that facilitates LVAD implantation without CPB, making the implantation safe, reproducible, and widely applicable may improve results and broaden the application of LVAD technology by changing this perception.
Postoperative hemorrhage has been cited in numerous published reports to be the most frequently seen complication after LVAD implantation. Massive transfusion can exacerbate end organ dysfunction resulting in morbidity and mortality as well. CPB requires systemic heparinization and irreversibly interferes with platelet function. In a small series of LVAD implantations performed without CPB at the Texas Heart Institute, transfusion requirements, length of stay, and morbidity decreased dramatically.