1 / 14

PROPEL Contour: Complete the PROPEL Portfolio with Reliable Results

PROPEL Contour is the "right fit" to complete the PROPEL portfolio for sinus ostia. It provides reliable results for frontal and maxillary sinus solutions, as well as a total ethmoid solution for smaller anatomy. With its evolutionary design and low profile malleable tip, PROPEL Contour offers superior clinical outcomes in the sinus ostium. It is backed by level 1-A evidence and reduces the need for post-operative interventions.

aesther
Télécharger la présentation

PROPEL Contour: Complete the PROPEL Portfolio with Reliable Results

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Right Fit to Complete the PROPEL Portfolio

  2. PROPEL Contour. Completes the PROPEL Portfolio. The “Right Fit” to Complete the Portfolio with Reliable Results For Sinus Ostia: Frontal /and maxillary sinus solution Total Ethmoid solution For “Smaller Anatomy”: Anterior Ethmoid and Frontal sinus recess PROPEL, the only implants backed by Level 1-A evidence which improve sinus surgery outcomes Reliable Results refers to PROPEL family, based on Pilot, Advance II, and PROGRESS studies

  3. PROPEL Contour. Right Fit. Reliable Results. Adaptable Hourglass Shape • Conforms to sinus ostium for maximum apposition, drug delivery, and outflow1 Low Profile Malleable Tip • 2.8 mm tip for access to small sinus ostium • Malleable tip for access to variable anatomy Superior Clinical Outcomes1 63% • Reliable results in the frontal sinus ostium compared to surgery alone Reduction in occlusion/restenosis* 1Data on file. *Secondary Endpoints judged by clinical investigators. Reliable Results refers to PROPEL family, based on Pilot, Advance II, and PROGRESS studies.

  4. Evolutionary Design for Maximum Apposition to the Sinus Ostium • Distinct PROPEL Contour Attributes • Hourglass shape to maximize tissue apposition • Small profile with no loops for small sinus ostium • PROPEL Family Similarities • Spring like expansion for mechanical spacing • Bioinert polymer backbone absorbing over 30-45 days1 • Delivers 370 μg of mometasone furoate over 30 days to reduce inflammation1 15.5 mm 8 mm 9 mm 1Li PF, Downie D, Hwang PH. Controlled steroid delivery via bioabsorbable stent: Safety and performance in a rabbit model. American Journal of Rhinology & Allergy. 2009.

  5. Low Profile, Malleable Delivery System for Access to Small Sinus Ostium • Design builds on PROPEL delivery system • Same simple deployment mechanism • Precise, consistent and simple placement Low Profile Tip 2.8 mm tip for easy access to small sinus ostium Tip Length: 16 mm Sheath Length: 125 mm Malleable Tip Bends between 70-110° for variable anatomy

  6. PROGRESS Study: Contour Cohort Prospective, randomized, blinded, controlled study. Intra-Patient Control: ESS + PROPEL Contour vs. ESS alone N = 80 patients Participating Sites = 12 National Principal Investigator: Amber Luong, MD, PhD (Univ of TX-Houston) Treatment side: Frontal sinus surgery + PROPEL Contour + standard post-op care Control side: Frontal sinus surgery + standard post-op care

  7. Rigorous Study Design to Demonstrate Clinical Performance of PROPEL Contour Key Inclusion Criteria • CRS confirmed by CT and defined as symptoms 12+ weeks • Clinical indication for ESS including bilateral frontal sinus surgery. Confirmed by Lund-Mackay score of ≥1 • Successful frontal sinus enlargement using Draf II (A or B) dissection and/or balloon dilation, with minimum of 5-mm diameter opening created. • Prospective • Randomized • Blinded • Intra-patient Control Primary Endpoint • Reduction in need for post-operative interventions at Day 30, by an independent, blinded surgeon based on video-endoscopy reviews. • Post-operative intervention is a composite endpoint of either: • Surgical intervention required to debride adhesions or scar tissue formation in the FSO, and / or • Oral steroid intervention warranted to resolve recurrent inflammation, edema or polyposis in the frontal recess/FSO n=80 12 US Sites

  8. PROGRESS Study: Contour Cohort Patient Demographics1 • Only ~50% of patients in this cohort had polypoid edema, vs. ~75% in Mini Cohort • Higher percentage of balloon dilation patients compared to PROGRESS Mini cohort 1Data on file

  9. Significantly Reduces the Need for Post-Operative Interventions at 30 Days1 PROGRESS Study: Contour Cohort Results 65% p=0.0023 Adaptable hourglass shape designed to conform to patient anatomy to deliver superior outcomes over surgery alone 1Data on file. N=80 in ITT population, with N=61 evaluable patients where both sinuses available for composite endpoint. Green arrow indicates relative reduction 30 days following treatment. Results judged by independent reviewer.

  10. Demonstrated Reduction in Occlusion/Restenosis1 PROGRESS Study: Contour Cohort 30 day Results1 73% 63% 35% p=0.1094 P<0.0001 p=0.0156 Reduction in occlusion/restenosis sustained through 90 Days* • 1Data on file. Judged by clinical investigators. *P-values for secondary efficacy endpoints were adjusted for multiplicity. Green arrows indicate relative reduction 30 days following treatment.

  11. Superior Clinical Outcomes in the Sinus Ostium1 Surgery + PROPEL Contour Surgery Alone After Frontal Sinus Surgery Polypoid edema 30 days Post-Op 1Data on file. Case represents one patient experience. Results may vary.

  12. PROPEL Contour. Right Fit. Reliable Results. Adaptable Hourglass Shape Specifically for Sinus Ostium 63% Superior Clinical Outcomes in Frontal Sinus Ostium Compared to Surgery Alone1 Reduction in occlusion/restenosis* Completes the PROPEL Product Family with Reliable Results 1Data on file. *Secondary efficacy results were judged by Clinical Investigators. Reliable Results refers to PROPEL family, based on Pilot, Advance II, and PROGRESS studies.

  13. WWW.INTERSECTENT.COM

  14. The PROPEL sinus implants are intended for use after sinus surgery to maintain patency and to locally deliver steroid to the sinus mucosa: PROPEL for use in the ethmoid sinus, PROPEL Mini for use in the ethmoid sinus and frontal sinus opening, and PROPEL Contour for use in the frontal and maxillary sinus ostia. The implants are intended for use in patients ≥18 years of age. Contraindications include patients with intolerance to mometasone furoate (MF) or a hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implants in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For complete prescribing information see IFU at www.IntersectENT.com. Rx only. MPM 00342 Rev. A

More Related