Some of us around here been doing open heart cases for many years now, but we’ve never seen The Sternal Talon® device, a product of KLS Martin LP of Jacksonville, FL. The device, 510(k)’ed by the FDA as a Class II device, is now enrolled in clinical trials “to establish if the Rapid Sternal Closure System improves early postoperative recovery as manifested by decreased pain and improved pulmonary function,” according to the NIH study summary.
Here’s what the company has just announced:
KLS Martin LP, a medical device company specializing in craniomaxillofacial and sternal fixation, announced today the implantation of the Sternal Talon(R) in the 500th patient.
The Sternal Talon(R) is an alternative method of closure for midline sternotomies used in many heart procedures and utilizes rigid orthopedic-style fixation. Originally developed in conjunction with surgeons at Duke University and surgeons in Tulsa, OK, as a reconstructive alternative for patients with sternal instability and non-unions, the Sternal Talon(R) has been used successfully in primary closure for patients undergoing midline sternotomy for CABG (coronary artery bypass graft) and valvular surgery. Many of these 500 patients had multiple comorbidities, which often lead to significant infections that can be fatal. These patients represent a truly difficult population for sternal closure and until recently the cardiothoracic surgeon had very few treatment options.
"The most common method of sternal closure remains sternal wire, but this is not without problems, especially in the larger patients," says Dr. Arch Miller, one of the inventors from Tulsa, OK. "The patients often exert forces on the wires that can cause the wires to break, pull through the bone or loosen which can lead to sternal instability, infection and increased pain." Using the Sternal Talon(R) on patients with higher BMI (body mass index) improves the chances for better fixation, potentially reducing the risk of sternal complications and resulting in lower patient pain scores allowing them faster recovery.
"One of the most surprising outcomes of the use of the Sternal Talon(R) was the reaction of the post-operative nursing staff who commented that you could tell which patients had the Sternal Talon(R) as they were up and moving around quicker with less pain," said Dr. Miller.