Investigator-Sponsored Research Program

Research areas

Each Boston Scientific division reviews research requests for a variety of topics pertaining to Boston Scientific products and associated disease states.

We are currently looking for research in the following areas:

Interventional Cardiology/Structural heart topics of interest

TAVR: Acurate™ Aortic Valve System

• Efficacy in complex cases, unique aortic anatomies and subpopulations
• Embolic protection
• Health economics analysis
   

WATCHMAN™ Appendage Closure Device

• Imaging
• Health economics data
• Blood thinner comparative data
• Subgroup analysis
   

Complex PCI

• FFR, iFR, DFR usage
• Health economics and efficiency analysis
   

Stents and Balloons

• Agent and Synergy applications and sub-population data
   

Rhythm & Electrophysiology Topics of Interest

ELECTROPHYSIOLOGY: Cardiac Mapping and Ablation

Personalization of Ablation Strategy

• Atrial fibrillation strategy personalization when considering multiple technology options
  
  

Ultrahigh Density Mapping and RF Ablation Catheters

• Characterization and prospective evaluation of local impedance-guided AF ablation using DIRECTSENSE™ (INTELLANAV MIFI™ OI & STABLEPOINT™ Catheters)
• DIRECTSENSE workflow and substrate characterization in complex cases
• High-power short-duration ablation workflow for pulmonary vein isolation
• Procedural best practices and outcomes with state-of-the-art technology, including RHTYTHMIA HDx™ with ultra-high-definition mapping and/or DIRECTSENSE, AutoTag, and LUMIPOINT™ features
• Substrate mapping and scar voltage characterization using RHYTHMIA HDx
  
  

PVI with Cryoablation Technologies

• Optimal dosing strategy for cryoablation using the POLARx™ cryoballoon
• Procedural best practices, efficiencies, and long-term clinical outcomes
  
  

RHYTHM MANAGEMENT Devices

Heart Failure Diagnostics on CIED Devices

• Intersection of HeartLogic™ and arrhythmic events and monitoring (e.g., arrhythmia burden, intervention decision & monitoring of response)
• Data management and workflow strategies utilizing HeartLogic alerts
• Treatment protocols for the whole alert cycle and relation to clinical outcomes
  
  

Implantable Cardiac Monitor

• Comparison of data management and clinic burden between LUX-Dx™ and other monitoring systems
• Use and performance of novel features including AT algorithm or remote programming
• User experience including implant and signal quality
• Patient experience and usefulness of mobile applications
  
  

Subcutaneous ICD

• Best practices to assure long-term device efficacy for spontaneous arrhythmias, particularly at device changeout

Endoscopy Areas of Interest

• SpyDiscover (Surgical or Percutaneous) 
• Cholangioscopy and Bil RFA in Occluded Bil SEMS 
• Biliary RFA focused on improving life expectancy and reducing re-intervention rates
• Hybrid ESD or Hybrid EMR as a step to ESD using ProKnife
• Single-use duodenoscopes 
• Single-use bronchoscopes 
• Clipping for:
  • Anchoring of J-tubes
  • Marking
  • Closure
• Specific areas of interest in these topics include but are not limited to the following:
  • Economic Data (Reduced procedural time, decreased length of hospital stay, reduced complications, lower hospital)
  • Safety and efficacy

Urology and Pelvic Health Topics of Interest

Urolithiasis

• Treatment outcomes in upper tract urinary stone disease
   

Benign Prostatic Hyperplasia (BPH)

Rezūm™ Water Vapor Therapy

• Patient Experience
  • Optimizing patient experience without compromising efficacy
• Effectiveness
  • Treatment durability
  • Volume reduction
  • PSA reduction/control
• Sexual Function Preservation
• Disease Progression
  • Comparative impact on BPH disease progression (compared to medications, MITs, and invasive surgical options)
• Health Economic & Cost-savings
• Economic impact compared to other BPH treatments

GreenLight™ Laser Therapy System

• Patient experience compared to other BPH treatment types
  • Safety, recovery, and durability of outcomes
  • Day case procedures and increased OR efficiency
• Treatment techniques
  • Impact of technique on patient outcomes
  • Optimization of treatment plans
• Patient Selection
  • Relevant comorbidities and increased risk of bleeding
  • Core considerations for PVP as primary treatment (patient phenotype)
  • PVP as a secondary treatment (following prior treatment failures) 

Oncology Hydrogels – Prostate Cancer

• SpaceOAR™ and SpaceOAR Vue™ Hydrogels for GU Toxicity, GI & GU QOL
• Spacing in moderate and extreme hypofractionation, dose escalation and lesion boost
• Impact of CT visibility on contouring, planning, visualization and adaptive therapy
• Spacing in high-risk patients and extracapsular extension (non-posterior)
• Comparative studies on SpaceOAR Vue advantages relative to other rectal spacers

Female Stress Urinary Incontinence

• The case for minislings as standard of care therapy for stress urinary incontinence
  • Patient experience
  • Economics
• A systematic review and meta-analysis of the safety and efficacy of urinary slings for treating female stress urinary incontinence
• Incidence of complications following sling surgery in high risk women (obesity, medical comorbidities, concomitant hysterectomy etc.)
• Learning curve for Solyx
   

Pelvic Floor Reconstruction

• Use of Capio in native tissue repair for prolapse
• Safety and efficacy of Y- mesh implanted by transabdominal route
   

Male Stress Urinary Incontinence

• AUS / AdVance XP vs comparative device studies or succession of prior procedures
  • Patient and/or Caregiver satisfaction and experience
  • Performance & treatment outcomes
• AUS / AdVance XP outcomes on sub-patient populations 
  • Obese, elderly, trauma, neurogenic (i.e. spina bifida)
  • Post BPH procedures: TURP, brachytherapy, etc.
  • Sub-sequent radiation treatment post-device implant
• Atrophy & Erosion studies
• Female AUS studieso Causes for revision, outcomes, best practices
  • Outcomes in conjunction with prolapse repair
  • Patient selection: sling/mesh vs AUS
• Continence and ED
  • Impact of AUS / AdVance XP on sexual function/satisfaction
  • Outcomes with AdVance XP or AUS and IPP combination
• Economics of Incontinence
  • Coping costs (i.e. pads/laundry/pills)
  • Economic impact on societyo Patient productivity
  • Mental health
• Benefit of diagnosing Incontinence
  • Cardiovascular
  • Diabetes
  • Obesity
    

Male Erectile Dysfunction (ED)

• Corporal measurements, measurement technique, and resulting cylinder size
• Cylinder sizing methodology/technique
• Satisfaction associated with specific cylinder sizes
• Same sex partner and patient satisfaction
• Safety and performance (erectile function satisfaction) outcomes associated with anal penetration utilizing a penile prosthesis
• Tactra™ Malleable Penile Prosthesis / Spectra™ Concealable Penile Prosthesis post-AMS 700™ Inflatable Penile Prosthesis
• AMS 700, post-Tactra/Spectra – satisfaction, complications
• Reservoir fill volumes and satisfaction
• Reservoir model, fill volumes and cylinder size. 
• Penile prosthesis, post-Rezūm therapy
• Repetitive high impact activities (biking, horseback riding and scuba diving), post-penile prosthesis: outcomes.

Neuromodulation Topics of Interest

• Spinal Cord Stimulation
  • Treatment of chronic, intractable pain of the back and legs using the Spectra WaveWriter™ SCS System
    • Of particular interest:
      • Efficacy of combination therapy
      • Programming optimization
      • Contour™ field shaping algorithm vs other field shapes
      • Anatomical vs paresthesia-based neural targeting
• Deep Brain Stimulation
  • Treatment of Parkinson’s Disease and other movement disorders using Vercise™ Deep Brain Stimulation System
    • Of particular interest:
      • Freezing of gait
      • Replacement of other DBS systems with Vercise DBS System
      • Use of multiple frequencies on one lead
      • Use of current fractionalization to maximize overlap with desired structures and minimize stimulation of non-target tissue
      • Novel targets for Parkinson’s Disease, Dystonia, Tremor (may require IDE)