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<INSTITUTION>implants heart valve without SURGERY
<City/State, Date> – Signaling a new frontier in the treatment of congenital heart defects and damaged heart valves, institution announced today that it has successfully performed itsfirst transcatheter pulmonary heart valve replacement procedure, a non-surgical alternative to open-heart surgery.
The patient received the Melody Transcatheter Pulmonary Valve and was discharged [#] day[s] later. The Melody valve, from Medtronic, is the first medical device of its kind to be approved by the FDA. It was approved [date] under a humanitarian device exemption, a special regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year.In January 2015, the Melody TPV received Pre-Market Approval (PMA) from the FDA based on strong clinical evidence from three clinical studies demonstrating the valve’s safety and effectiveness in delaying open-heart reoperation.
“Each and every day I witness the effects that multiple open heart surgeries have on patients’health and the anxiety that their families suffer, said <insert local physician’s name and title>. “We’re excited to be able to offer the Melody valve so that appropriate patients have access to a much less-invasive treatment option.”
Physician name> further stressed that physician collaboration is key to helping congenital heart disease patients manage their condition. “Effective management of congenital heart defects over a patient’s lifetime requires dedicated cooperation between cardiac surgeons, interventional cardiologists and other clinicians,” <insert local physician’s name> said. “Together, we can draw on a variety of treatment options, and Melody is an important addition to the choices available to us.”
Congenital heart disease patients often require open-heart surgery to restore effective blood flow to their lungs. Previously, the only way to repair or replace a failed pulmonary valve conduit was through additional surgeries. With the availability of this new transcatheter technology, physicians now have a non-surgical means to address pulmonary valve conduit dysfunction. The procedure allows an interventional cardiologist to deliver a replacement valve through a catheter requiring only a small incision, thus eliminating the immediate need to open the chest and delaying the patient’s next surgical intervention.
About <Institution>
Insert information here about the treating institution.
OTHER SUGGESTED PHYSICIAN QUOTES:
- “To reopen the chest many times is obviously uncomfortable for the patient but also comes with great risk. By using the Melody valve we can delay the patient’s next surgical intervention.”
- “The Melody valve is an example of our institution’s commitment to the adoption of less invasive cardiac procedures for patients with congenital heart disease. By providing less invasive options thatdelay open-heart surgery, we hope to improve patients’ quality of life.”