Boston Scientific Highlights Positive Five-Year Clinical Data for Intracept® System, the Only FDA-Approved Treatment for Vertebral Body Pain at ASPN 2024

Jul 19, 2024 22:15 CST Updated 22:15

Boston Scientific

Medical Device Manufacturer

Boston Scientific Announces FDA-Approved Treatment for Discogenic Low Back Pain at ASPN 2024---IntraceptData from three clinical studies. The studies showedIntraceptPositive Clinical Outcomes in the Treatment of Vertebrogenic Low Back Pain.

Specific Research Data

Boston Scientific announces five-year follow-up for these three studiesResearch data on the Oswestry Disability Index (ODI) before and after Intracept treatmentVisual Analog Scale ( VAS）Comparison was performed (a total of 249 patients were compared).：

Compared with the baseline, there were significant improvements (statistically significant) in pain (measured by VAS on a 0-10 scale) and function (measured by ODI on a 0-100 scale) five years after surgery.
Approximately 83% of patients reported VAS compared to baselineAt leastDecreased by 2 points (p<0.0001)
About 78% of patients had an ODI decrease from baseline.At leastDecrease by 15 points (p<0.0001)
Nearly 66% of patients experienced a reduction in pain relief of 50% or more (p<0.0001).
Nearly one-third of patients reported being 100% pain-free after five years (p<0.0001).

Executive Evaluation

"These five-year comprehensive results furtherProven that Intracept provides lastingSafety, efficacy, and repeatability in alleviating vertebrogenic pain. The data contained in ASPN also highlights our focus on providing a range of clinically validated solutions to transform the lives of patients with chronic pain."

---Ray Baker Vice President and Chief Medical Officer of Boston Scientific Neuromodulation

IntraceptThis product was acquired by Boston Scientific for $850 million in 2023. With itsIntraceptCompared with traditional therapies (such as nerve block therapy, visualized needle-knife therapy, and silver needle release therapy), it has inherent advantages and superior efficacy, further enhanced by the commercial capabilities of Boston Scientific Corporation.IntraceptThe number of treated patients doubled from over 10,000 to more than 30,000 within a year, showingIntraceptHuge Market Potential.

According to statistics in the United StatesAmong 30 million people with lower back pain, more than 5 million areVertebral SourcePain during intercourse. In additionIntraceptIt is the only FDA-approved device for treating vertebral-origin low back pain, which willIntraceptDoubling growth in the coming years.

BesidesIntraceptIn addition, Boston Scientific has gradually formed a complete set of solutions in the field of pain management. For example, the WaveWriter Alpha spinal cord stimulator, radiofrequency ablation, and Vertiflex, among others. These provide doctors and patients with more choices to meet their unique needs.

Intracept

IntraceptIt is a minimally invasive, implant-free outpatient surgical treatment.Vertebral-origin pain surgery。IntraceptUsing targeted radiofrequency energy to block the vertebral basal nerves from transmitting pain signals to the brain, aiming to improve function and provide long-term relief.IntraceptThe treatment duration is only one hour, very simple and fast.

IntraceptSuitable for various bone densities, composed of the following components:

Bevel and Diamond Introducer: Assists in stable entry into the BVN, with depth markers to optimize positioning.
Curved Catheter Assembly and J-shaped Needle: Can truly steer, forming a predictable pathway to the BVN.
Straight Needle: Can effectively extend or alter the direction of the entry path.
Intracept Radiofrequency Probe: Capable of delivering targeted radiofrequency energy and increasing C-arm operational space.

IntraceptAlso includes a radiofrequency generator, specifically designed for ablating the basivertebral nerve. Its features:

An intuitive step-by-step user interface simplifies the setup and implementation of ablation therapy.
Real-time power management adjusts temperature and heating rate to ensure efficient ablation.
Two sets of ablation parameters can provide treatment options based on the position of the Intracept radiofrequency probe.

Intracept Demonstration

Boston Scientific

Boston Scientific Corporation transforms lives and improves the health of patients around the world through innovative medical technologies. As a global leader in medical technology for over 40 years, we advance life sciences by delivering a wide range of high-performance solutions to meet unmet patient needs and reduce healthcare costs. Our portfolio helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological, and urological diseases and conditions.