August 7, 2008 - KLS Martin LP, a medical device company specializing in craniomaxillofacial and sternal fixation, yesterday announced the implantation of the Sternal Talon in the 500th patient.
The Sternal Talon 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 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,” said 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 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, the company said.
Currently, KLS Martin Sternal Talons are available in a select group of heart hospitals in the U.S. The initial experience and feedback from doctors, nursing staff and patients is very positive, the company said.
A multi-center study to evaluate the outcomes of similar high-risk patients with standard wire closure compared to the Sternal Talon is underway with the team at Duke University Medical Center and results should be available in the next 18 months. The study at Duke is being led by physicians other than those who were involved in the initial development of the Sternal Talon.
For more information: www.klsmartin.com, www.rapidsternalclosure.com