Medtronic Partners with AI Firm OM1 to Study Real-World Outcomes of PROPEL Sinus Implants

Apr 11, 2024 00:23 CST Updated 00:23

Medtronic

Medical Device Manufacturer

OM1

Developer of Large-scale Data Analysis Platforms in the Medical Field

Source: Siyu MedTech; Editor: Sophia

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On April 10, 2024, Medtronic (NYSE: MDT) announced a research collaboration with OM1, a leading company in artificial intelligence technology, to evaluate the PROPEL.^TMRelevant data.PROPEL^TMis aNasal Sinus Stent, Same TypeThe first product that combines localized steroid-release technology to deliver medication to specific sinus tissues, with clinical trial results reaching Level 1-A.

Propel Contour Implants

It is reported that this cooperation will focus on the long-term use outcomes of patients with chronic rhinosinusitis (CRS) who undergo endoscopic sinus surgery (ESS).

# Research Background

It is estimated that CRS costs patients and the healthcare system $10 to $13 billion annually in the United States alone due to outpatient visits, prescription drug treatments, and sinus surgeries.

As one of the most common surgical procedures in the United States (with over 250,000 surgeries performed annually), ESS patients often require postoperative intervention to separate adhesions or may additionally need oral steroids to treat inflammation.

Although some patients can control symptoms through medical means, postoperative challenges may still limit the therapeutic effect of sinus surgery. Common challenges include:

Surgical incision scar or stenosis;
Recurrent inflammation and polyposis;
Inadequate local treatment;
The anatomical boundaries of the frontal sinus are narrow, resulting in limited dimensions for sinusotomy;
A common complication is middle turbinate lateralization (MTL), which may be associated with an increased risk of revision surgery.

Overall, postoperative inflammation and potential diseases related to surgery are difficult to predict and may hinder the benefits of the surgery.

Therefore, a safe and effective postoperative care regimen is needed to effectively deliver corticosteroids to the sinuses and minimize reliance on patient compliance.

# PROPEL Series Products

PROPEL Sinus Implant

PROPEL received FDA premarket approval on August 15, 2011. This product is the first sinus stent to integrate localized steroid-release technology, delivering medication to specific sinus tissues, with clinical trial results reaching Level 1-A.

The product is 23mm in length, acts on the ethmoid sinus, and can effectively separate mucosal tissue, stabilize the middle turbinate, prevent adhesion and blockage, and avoid tissue edema. PROPEL, while maintaining the sinus opening, reduces the incidence of postoperative scarring, inflammation, polyps, and middle turbinate lateralization, helping patients improve long-term outcomes and avoid secondary surgery.

PROPEL Mini

PROPEL Mini was approved by the FDA on November 6, 2012. This product is a smaller version of PROPEL, with a length of 16mm, but it has the same drug dosage and clinical benefits as PROPEL and a broader range of indications. PROPEL Mini can be used in ethmoid and frontal sinus surgeries, resulting in smaller surgical wounds. Its miniature size and curved delivery tube make it easy to place and more adaptable to the sinus opening.

PROPEL Contour

PROPEL Contour was approved by the FDA on February 24, 2017, as the latest product in the PROPEL series. This product is smaller than the PROPEL Mini, with a length of only 2.8mm. Its delivery tube is funnel-shaped, highly malleable, conforms to the sinus ostium, and can maximize postoperative recovery for patients undergoing frontal and maxillary sinus surgeries. On November 15, 2018, Intersect ENT announced the analysis results of PROPEL Contour and PROPEL Mini, showing that compared with conventional sinus surgery, the placement of their PROPEL frontal sinus implants during surgery improved treatment outcomes for frontal sinus procedures. By the 30th day after the implantation of PROPEL Contour, 46.8% of patients did not require postoperative intervention.

# Results and Limitations of Real-World Studies

Previously, there was a real-world study on the Propel product that included 3,966 adult patients with CRS, with or without nasal polyps, evaluating the impact of the PROPEL series of implants on healthcare resource utilization within 18 months after sinus surgery.

Research Conclusion:

Total ENT VisitsRelativeReduced by 23%;
Total Emergency/Urgent Care VisitsRelatively reduced by 25%;
Total outpatient visitsRelativeReduced by 2%;
Endoscopic Examination of Paranasal SinusesA relative decrease of 11%;
Revision Sinus SurgeryA relative decrease of 14%.

However, the data and results of this real-world study have limitations.

Real-world studies cannot definitively establish causality and are aimed at assessing associations;

The data source cannot identify the specific sinus where the implant was placed.

This may also be why Medtronic is partnering with OM1 to continue research and evaluate the performance of the PROPEL series products.

# About Medtronic and Intersect ENT

As early as 2022,Medtronic Acquires Intersect ENT's Propel and Sinuva Drug-Eluting Sinus Implant Product Lines, Technology, Intellectual Property, and the Company's Menlo Park Facility.

Medtronic’s acquisition of Intersect ENT will expand its portfolio of products used during ENT surgeries. Intersect ENT's sinus implants, named PROPEL and SINUVA, are clinically proven solutions that open sinus passages and deliver anti-inflammatory steroids to aid in healing.

# About OM1, Inc.

OM1 Focuses on the Chronic Disease Field, ThroughDeveloping a Large Network of Clinicians with Electronic ConnectivityReimagine real-world evidence and insights with health data from dermatology, rheumatology, gastroenterology, cardiology, metabolism, respiratory, mental health, neurology, and other specialties.

Utilize itsData Automation Platform OM1 Aspen, Extensive Clinical Network, and Artificial Intelligence (AI) Platform PhenOM™OM1 provides a wealth of medical datasets, retrospective and prospective studies, advanced analytics, and AI-driven guideline adherence and decision support surrounding diagnosis, risk management, and treatment.

These products focus on high-quality data and clinical outcomes, used to accelerate research, demonstrate treatment effectiveness, support regulatory submissions, monitor safety, and inform commercialization.

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Editor-in-Chief | Zhao Qing Reviewed by | Yi He