St. Francis Participates in Landmark Study Using Sonic Pressure Waves to Treat Heart Blockages
Hospital Enrolls First Patient in the U.S. for DISRUPT CADIII Clinical Trial Investigating Potential of Novel Shockwave Technology to Break Up Problematic Calcium in Heart Arteries
Roslyn, NY – January 15, 2019 –St. Francis Hospital, The Heart Center® is now participating in a major clinical trial investigating a new treatment option for those suffering from an advanced form of coronary artery disease (CAD) in which plaque blockage also includes the presence of calcium. Intravascular Lithotripsy (IVL) is an innovative technology that generates sonic pressure waves – also known as shockwaves – to break up the calcium so that an artery can be opened and blood flow restored with the placement of a stent. The therapy relies on a similar minimally invasive approach that has been used by physicians for decades to treat kidney stones, which are also made up of calcium.
“We are thrilled to be the first hospital in the U.S. to investigate this innovative technology that can potentially benefit heart patients in our region,” said Richard Shlofmitz, M.D., FACC, Chairman of Cardiology, who enrolled the first patient last week. “Hardened calcium within the heart is becoming more common as people are living longer and is very challenging to treat. If sonic pressure waves can break up calcium in a safe and effective manner, then this technology could be a game changer for how we treat advanced coronary artery disease.”
Calcium can slowly develop and progress to a hardened, bone-like state in the heart’s arteries over the course of several decades. While slow to develop, its impact is immediately seen when doctors perform procedures in calcified lesions. The calcium’s hardened structure restricts normal artery movement and makes the rigid arterial tissue resistant to traditional balloon therapies that have been designed to compress the plaque within the artery wall to restore normal blood flow. For these reasons, the presence of calcium increases the complexity of most cases and decreases the effectiveness of most treatments.
This major study is designed to enroll 392 patients at 50 hospitals worldwide and follow the patients for up to two years. While shockwave catheters are commercially available in in Europe, they are limited to investigational use in the United States.
How Intravascular Lithotripsy (IVL) Works
Intravascular Lithotripsy uses a small generator to produce sonic pressure waves from a catheter that is threaded through the arterial system to the site of the blockage in the heart. The technology was designed to produce pressure waves that pass safely through the soft vascular tissue, only impacting the hardened calcified plaque inside the artery wall by creating a series of micro-fractures. After the calcium has been modified, the artery can be expanded using a low pressure balloon and a stent, thereby enabling even historically challenging CAD patients to be treated effectively with minimal injury to the vessel. For an animation of the procedure, visit www.intravascularlithotripsy.com.
Contact: Rosemary Gomez, 516-563-7965, firstname.lastname@example.org