Areas of Research Interest

Our IIS Program will consider all relevant research proposals that meet the IIS study criteria. Areas of specific interest as well as researches not of current focus for each company are outlined below. Additionally, proposals that include a diverse patient population regarding race, ethnicity, age, and sex are highly encouraged.

BIOSENSE WEBSTER, INC.

1. Atrial Fibrillation (AF) ablation using VISITAG SURPOINT® Module or QDOT MICRO™ Catheter using QMODE+™ and QMODE+™ Modules to assess:
   • 12-month clinical outcomes and healthcare utilization
   • Fluoroscopy minimization with CARTO VIZIGO® Sheath
   • Workflow simplification/optimization
   • Pain tolerance of ablation procedures under conscious sedation
   • Impedance and energy parameters with the use of QMODE+ Module
2. Assessment of contemporary high-density mapping catheters (e.g., Octaray, Optrell)* and CARTO V7 (or higher) technologies* with a focus on:
   • Arrhythmia mechanism and tissue/lesion characterization as well as clinical outcome in complex atrial tachycardia (AT), ventricular tachycardia (VT), and persistent AF
   • Reproducible mapping workflow
3. Determination of optimal ablation strategy in persistent AF to assess AF burden reduction, target identification, and targeted ablation strategies
4. Healthcare disparities of AF patients across racial/ethnic minority groups and different age/gender populations:
   • Understanding the barriers to healthcare access and outcome variation among AF patients
   • Assessment of possible unconscious biases and diagnostic challenges
   • Exploring the core reasons and attributes for the AF Paradox (higher risk factors/lower prevalence) in the care of AF minority patients
5. Clinical benefit of VT ablation with the QDOT MICRO™ Catheter*
6. Real world experience with HELIOSTAR™ RF balloon catheter* with a focus on:
   • Ablation procedure with or without esophageal temperature monitoring probes
   • Workflows optimization for reducing fluoroscopy and increasing lesion durability
   • Pain tolerance of ablation procedures under conscious sedation
7. Real world experience with intracardiac echocardiography (ICE) using SOUNDSTAR® Catheter* or NUVISION® 4D Catheter* with focus on:
   • Workflow to improve visualization of real-time catheter tracking and support substrate characterization
   • Improvement of procedural efficiencies including minimization of fluoroscopic exposure
   • Utility of ICE as an alternative to transesophageal echocardiography for left atrial appendage (LAA) thrombus/clot detection prior to AF ablation procedures
   • Utility of ICE in LAA occlusion procedures
8. Assessment of ablation approach and its success in preventing Sudden Cardiac Death (SCD) of any etiology (ischemic or non-ischemic)* in susceptible patients:
   • Methods to identify patients more susceptible to SCD or cardiac arrest
   • Procedure workflow to address the mechanism of SCD through ablation
   • Catheter ablation strategy and its clinical benefit
9. Catheter ablation procedures using CARTO VIZIGO® Sheath assessing optimal transseptal access, catheter-tissue contact stability, procedural efficiencies and lesion durability.

* IIS submissions will be accepted only from countries where the device is approved or cleared for marketing

CERENOVUS, INC.

Our current areas of interest include clinical research proposals involving the following new products:

1. Nimbus Geometric Clot Extractor
2. Large Bore Catheter / EmboVac Aspiration Catheter
3. EmboGuard Balloon Guide Catheter

In addition, modest requests for non-monetary funding such as those below will also be considered across the full Cerenovus device portfolio.

• Request for devices at no charge to be used in research
• Requests for statistical or medical writing services in support of a publication
• Safety and efficacy of mechanical thrombectomy in patient population with challenging occlusion
  Real-world experience of EmboTrap® and flow diverter*
  • AF burden reduction associated with persistent atrial fibrillation ablation
  • Identification of ablation targets beyond PVI using CARTO 3*, with 12-month or longer clinical outcomes
  • Strategy for segmenting early vs. advanced persistent AF patients

Please note that investigator initiated studies can only be approved and funded in a country/region where the product is commercially approved (i.e., proposals for a clinical research study on a device that is not commercially available in the country/region where the study will be conducted unfortunately cannot be considered).

ACCLARENT, INC.

1. Workflow using the TruDi® Navigation System and associated technologies, including but not limited to the impact on:
   • Clinical outcomes (e.g., recurrence, revision surgeries)
   • Procedural workflow and/or surgical planning and execution
2. Procedural and/or clinical benefits associated with RELIEVA TRACT™ Balloon Dilation System
3. Evaluation of nasal airflow pre- and post-operative following dilation with the RELIEVA TRACT™ Balloon Dilation System, with objective and/or subjective outcome measures, such as:
   • Patient-Reported Outcome Measurements (e.g., NOSE, VAS scale)
   • Peak nasal inspiratory flow (PNIF)
4. Treatment pathway for patients treated with Eustachian Tube Dysfunction
5. Healthcare resource consumption of patients diagnosed with Eustachian Tube Dysfunction
6. Long-term (one year and longer) clinical benefit associated with Eustachian Tube Balloon Dilation, with objective and/or subjective outcome measures, such as:
   • Tympanogram
   • ETDQ-7

MENTOR WORLDWIDE, INC.

1. Long-term safety data, including rupture, on MemoryGel® Breast Implants
2. Clinical outcomes and biomechanical properties of MENTOR® devices including, but not limited to Memory Gel® BOOST Breast Implants, MemoryGel® Xtra Breast Implants, ARTOURA™ Breast Tissue Expander, CPX®4 Breast Tissue Expander
3. BIA-ALCL studies on MENTOR® devices in a pre-clinical setting
4. Utility of two-stage reconstruction
5. Effective communication strategies for patients
6. Systemic symptoms associated with women who have breast implants
7. Clinical outcomes related to pre-pectoral reconstruction

* In countries with approved indication