Sternal Closure Face-Off: ZipFix vs. Traditional Wire – Which Method Wins?
"A one-year follow-up study reveals surprising insights into pain levels, dehiscence rates, and overall patient comfort after sternotomy."
For decades, closing the sternum after open-heart surgery has relied on stainless steel wires, a method considered the gold standard due to its simplicity and low cost. However, this approach isn't without its downsides. Complications like dehiscence (separation of the sternal edges) and infections can lead to reoperations and prolonged recovery times. This has fueled the search for better solutions.
One promising alternative is the ZipFix system, a biocompatible, cable-tie-based sternal closure device made from poly-ether-ether-ketone (PEEK). ZipFix offers potential advantages like flexibility, ease of use, and strong, stable closure. But does it truly outperform traditional wires in the long run? Does it translate to tangible benefits for patients?
A recent study published in Heart, Lung and Circulation compared the outcomes of patients undergoing sternal closure with either ZipFix or conventional steel wires. Over a year-long follow-up, researchers tracked pain levels, dehiscence rates, and infection rates to determine which method truly comes out on top. This article unpacks the study's findings, revealing whether ZipFix lives up to the hype and offering valuable insights for anyone considering or facing sternal closure.
ZipFix Outcomes in Clinical Study
The ZipFix System uses a cable-tie principle that increases implant-to-bone contact through the intercostal space and is intended to provide rigid fixation, particularly for primary sternal closure in patients at risk. A randomized clinical trial compared the polymer ZIPFIX system with traditional wire cerclage after cardiac surgery in 118 patients. The cited account reports no difference in postoperative pain, the trial’s primary outcome, despite greater movement with ZIPFIX. A separate study description says it examined sternal infections, wound dehiscence, and postsurgical outcomes among patients closed with ZipFix bands and steel wire.
Wire Cerclage Remains the Standard
Conventional stainless-steel wire closure after median sternotomy has been considered the gold-standard method for more than half a century. Its ease of use and low cost help explain its continued acceptance. A 2025 review describes wire cerclage as the standard and notes little adoption of innovation in the preceding decade, while emphasizing that closure choices depend on patient, surgeon, and operative factors. The supplied source excerpt identifies limitations of wire closure but does not specify them.
A PEEK Cable-Tie System
The Sternal ZIPFIX™ System is primarily made up of PEEK implants and an application instrument. The AO Foundation’s 2011 description identifies the implants as biocompatible polyetheretherketone (PEEK), similar to cable ties, and says the system is intended to stabilize the sternum and promote fusion after sternotomy. The implant description includes a removable stainless-steel needle for peristernal application. A Medtech Expo account characterizes the system’s development—from initial idea and project collaboration through market launch—as a success story spanning more than 10 years.
ZipFix vs. Traditional Wire: A Head-to-Head Comparison
The study, a randomized controlled trial, involved 326 patients undergoing cardiac surgery. After the sternotomy, patients were randomly assigned to have their sternum closed with either ZipFix (168 patients) or conventional steel wires (158 patients). Researchers then meticulously followed both groups, assessing them at one, three, six, and twelve months post-discharge.
- Pain Severity: Measured using a visual analog scale (VAS) where patients rated their pain levels during cough.
- Sternal Dehiscence: Evaluated based on clinical findings such as sternal clicking or instability during respiration or coughing.
- Infections: Both incisional (superficial and deep) and organ/space infections (mediastinitis or osteomyelitis) were diagnosed according to established guidelines.
Alternatives and Follow-Up Findings
Wires remain the most-used sternal closure method, while proposed alternatives include clips, plates made from different metals, cables, and bands. A report on sternal implants compared 12-month follow-up results for 158 patients with conventional steel-wire closure; it describes better results for implants in pain and sternal dehiscence, but no statistically significant result for sternal wound infection. In a separate context, biocompatible cable ties have been reported for Nuss bar stabilization, with the cited snippet noting no significant bar dislodgement in Tam and colleagues’ initial report.
The Verdict: Is ZipFix the Future of Sternal Closure?
The study's findings suggest that ZipFix offers significant advantages over conventional wire closure, particularly in reducing pain and the risk of sternal dehiscence. While infection rates were similar between the two groups, the overall benefits of ZipFix make it a compelling alternative for patients undergoing sternotomy.
Projected Market Growth
A market forecast published September 15, 2026, projects the sternal closure systems market to reach USD 4.57 billion by 2035, up from USD 2.97 billion in 2026. It gives a projected compound annual growth rate of 4.90% for 2026–2035. These figures are the source’s market projections.
Of course, this study is just one piece of the puzzle. Further research with larger sample sizes and higher-risk patients is needed to confirm these findings and explore the long-term outcomes of ZipFix closure. Cost-effectiveness is another crucial consideration, as ZipFix is currently more expensive than traditional wires.
Ultimately, the choice between ZipFix and conventional wire closure should be made on a case-by-case basis, considering the individual patient's risk factors, preferences, and the surgeon's expertise. However, this study provides valuable evidence that ZipFix has the potential to improve patient outcomes and revolutionize sternal closure techniques.