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
   • First-pass isolation improvement with the use of a steerable sheath and optimized QDOT MICRO catheter workflow simplification/optimization
   • Pain tolerance of ablation procedures under conscious sedation
   • Impedance and energy parameters with the use of QMODE+ Module
2. Clinical benefit of ventricular tachycardia (VT) ablation with the QDOT MICRO™ Catheter
3. Assessment of 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, increased capacity of point acquisition and complex signal algorithm annotation accuracy
   • Maneuverability improvements and enhanced signal identification & substrate characterization
   • Utility of Electroanatomical Mapping, Anatomy Navigation and Ablation monitoring workflow integration in AF ablation procedures.
4. Determination of optimal ablation strategy in persistent AF to assess AF burden reduction, target identification, and targeted ablation strategies
5. Real world experience with intracardiac echocardiography (ICE) using SOUNDSTAR® Catheter* or NUVISION® Ultrasound Catheter* with focus on:
   • Workflow to improve visualization of real-time catheter tracking and support substrate characterization with enhanced image quality
   • Improvement of procedural efficiencies including minimization of fluoroscopic exposure in VT and AF ablation procedures
   • Improved anatomical navigation and contact with enhanced HD mapping catheters
   • Utility of ICE as an alternative to transesophageal echocardiography (TEE) or Computed tomography (CT) for left atrial appendage (LAA) thrombus/clot detection prior to AF ablation procedures
6. Catheter ablation procedures using CARTO VIZIGO® Sheath assessing optimal transseptal access, catheter-tissue contact stability, procedural efficiencies and lesion durability.
7. Clinical Value and RWE on AF ablation
   • Healthcare disparities and barriers to AF patients across racial/ethnic minority groups and different age/gender populations
   • impact of early Diagnosis-to-Ablation Time (DAT) on patient outcomes, recurrence rate and disease progression.
   • RWE on Drug Naïve AF patient populations
   • Reduced mortality, heart failure (HF) and hospitalization
8. Clinical Benefits and Workflow Recommendations using the VARIPULSE™ Platform
   • Long-term safety and effectiveness data on AF ablation including first-line paroxysmal AF, early persistent AF (PVI only), and tailored persistent ablation.
   • Workflow recommendations or transition from RF to pulse field ablation with 3D electroanatomical mapping, including: workflow and lab efficiencies, minimal to zero fluoroscopy, same-day discharge, learning curve, and sedation protocol.
   • Additional research topics using the VARIPULSE™ Catheter including:
   • Patient reported outcome including patient experience post-ablation
     • PV durability and/or preserved LA contractility analysis via 3-month remap or repeat procedure in the real-world setting
     • Clinical lesion characterization near scar or fat
     • PFA lesion development on previously RF treated tissue
     • PVI validation with the VARIPULSE™ Catheter (electrical vs. imaging)
     • TPI usage and efficacy outcomes
     • Efficacy and/or efficiency utilizing the CARTO system and specific CARTO SW modules such as ULS integration
     • Chronic effect of VARIPULSE treatment on neuromodulation (impact to GPs, heart rate, etc)

* 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