First-ever Prospective Evidence on Posterior Approach to SI Joint Fusion Reflects Improved Pain Scor
SI joint fusion with PainTEQ's LinQ implant shows promising results for patients with sacroiliitis
TAMPA, Fla., June 21, 2022 /PRNewswire/ -- Preliminary data from the landmark SI joint fusion study of Tampa-based medical innovation company, PainTEQ, reveals that a posterior approach to SI joint fusion with the LinQ implant improved pain scores over a period of three to six months.
The Single-arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device (SECURE) study is the first-ever comprehensive evaluation of PainTEQ's posterior approach. Initial data on 69 patients at six months revealed only one serious adverse event (SAE), suggesting that LinQ is safer than the competitor's lateral approach, which had a 15.1% SAE incidence.
The study states the SAE was unrelated to the research or the LinQ device.
"We are very encouraged by the interim evidence for the efficacy, safety, and durability of LinQ," said Aaron Calodney, MD, interventional pain physician and one of the study's key investigators. "The data – in terms of pain relief, functional improvement, and safety – support the use of LinQ as an important treatment within the algorithm of patients suffering from chronic sacroiliac joint disease as well as being grounded in high-quality prospective evidence."
Preliminary data on the SECURE study also reflects a significant improvement in VAS scores, a unidimensional measure of pain intensity. Patients treated with LinQ experienced a reduction in pain at the three, six and 12-month follow-ups, reinforcing the durability of the LinQ procedure (See Figure 1 & 2).
"In our planned interim analysis of our multicenter study, the six-month outcome has unparalleled safety and non-inferior results to the lateral fusion approach, compared to what is published in peer-reviewed literature," said Nomen Azeem, MD, another one of the study's investigators. "This represents the largest treatment arm for prospectively acquired sacroiliac joint fusion to date, across all approaches."
PainTEQ hopes the results from this landmark study will help encourage more pain physicians to adopt their posterior approach to SI joint fusion in an effort to help patients with sacroiliitis experience long-term pain relief and long-term joint stabilization.
"We are thrilled with the preliminary results of the SECURE study," said Sean LaNeve, PainTEQ's CEO. "This study is an important step forward in helping to validate the LinQ implant, and we are hopeful that it will encourage more pain physicians to adopt our approach in order to help their patients find long-term pain relief."
PainTEQ leadership is looking forward to sharing more data on the ongoing SECURE study as it becomes available.
About PainTEQ: PainTEQ was built to bring interventional procedures to the market. Working with pain management specialists to help reduce and eliminate SI joint dysfunction, PainTEQ's LinQ implant aims to immediately provide clinical benefits to individuals living with incapacitating lower back pain through a minimally invasive outpatient procedure.
About LinQ: The LinQ SI Joint Stabilization System provides patients with a minimally invasive option to combat pain. After a thorough diagnostic process, physicians may help alleviate, and in many cases eliminate, chronic pain by placing a single LinQ allograft into the SI joint. With its large graft window, this single implant helps create an ideal environment for long-term fusion.
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SOURCE PainTEQ
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