A University of Florida College of Medicine – Jacksonville physician has performed the world’s first implant of a regenerative bio envelope that protects a cardiac defibrillator implanted under the skin, a procedure that may offer better implant results and contribute toward better outcomes for patients.
John Catanzaro, MD, a cardiac electrophysiologist and assistant professor of medicine in the division of cardiology, implanted the envelope and defibrillator in a 39-year old patient suffering from a genetic condition that could cause the heart to stop suddenly.
The device, known as a subcutaneous implantable cardioverter defibrillator, is placed under the skin close to the heart using the novel bio envelope, which Catanzaro helped create. Defibrillators can instantly treat life-threatening arrhythmia by defibrillation, which resets the heart back to its normal rhythm, thereby saving a patient’s life.
“This is truly a breakthrough because this bio envelope not only physically protects the defibrillator, it also facilitates protection of the patient,” Catanzaro said. “A healthy environment is created within the implant site of the SICD, stabilizing it in a comfortable, natural fashion.”
The first implantation of the pouch was performed at UF Health Jacksonville in early January.
Catanzaro says without the bio envelope, the body identifies the defibrillator — which is about the size of a small smartphone — as a foreign agent and works to grow tissue around it through inflammation. Long-term inflammation can lead to calcification and lack of blood flow. The device is placed in the bio envelope at the end of the procedure when it is secured.
Aziyo Biologics Inc., a Maryland-based regenerative medicine company, partnered with Catanzaro to develop the XXL SICD CanGaroo Bio Envelope.
Catanzaro says the novel regenerative bio envelope is the first step toward stabilizing the device at implant to effectively deliver the lowest amount of focused energy that will successfully defibrillate the heart.
“It is a fantastic adjunct to the SICD at implantation. However, additional research is required to demonstrate long-term efficacy,” Catanzaro said. “Application of regenerative medicine within the field of electrophysiology, such as this, is an exciting and innovative move toward improving quality of life and saving lives.”