A San Ramon, California startup has received regulatory clearance to market its less invasive therapy for treating congestive heart failure.
BioVentrix announced that it has received the CE Mark for its Revivent Myocardial Anchoring System, which aims to improve cardiac function by restoring the size and volume of the left ventricle in heart patients. After a heart attack, there may be a large scar or aneurysm that alters the shape of the heart making it more rounded.
BioVentrix’s therapy excludes this scarred, nonfunctioning portion of the left ventricle to enhance its efficiency.
The device intends to be an alternative therapy to surgical ventricular restoration, which achieves the same outcome using a more invasive process and most often requires coronary artery bypass grafting to ensure that blood supply to the heart is being maintained.
Because of its invasive nature, many older, more frail patients cannot undergo the surgery. Revivent may be a new option for them, according to the company.
“Because of Revivent, the LIVE procedure can be performed without cardiopulmonary bypass; therefore, the heart is beating and stable, and there is no major surgical incision in the myocardium,” added Dr. Andrews S. Wechsler, professor of cardiothoracic surgery, Drexel University College of Medicine, Philadelphia.
BioVentrix recently submitted a regulatory filing with the U.S. Securities and Exchange Commission showing that the company is seeking $4 million. The company is also trying to develop a transcatheter approach to solving the issue of left ventricle efficiency.
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.
“We are also developing a second generation of Revivent — minimally invasive, sternal-sparing with transcatheter delivery on a beating heart — for patients who have suffered a heart attack but are too fragile to tolerate invasive heart surgery,” Kenneth Miller, BioVentrix’s president and CEO, said in a news release Monday.
