Structural heart R&D

Designing the next era of transcatheter care.

Physician-informed research and development focused on structural heart valve technologies, catheter-based therapies, and elegant solutions for complex anatomy.

R&D
Aortic
Valve
Mitral
Valve
Tricuspid
Valve
LAA &
Septal
Visual technology atlas

Anatomy and representative implant concepts.

Explore the target anatomy and the general form of catheter-based technologies used across contemporary structural heart care.

Cutaway heart anatomy with a representative transcatheter aortic valve implant
AORTIC VALVE

TAVR

A bioprosthetic valve frame positioned within the native aortic annulus.

Left atrial appendage anatomy with a representative occlusion implant
LEFT ATRIAL APPENDAGE

LAA Occlusion

A conformable occlusion implant seated at the appendage ostium.

Interatrial septal anatomy with a representative atrial septal occluder
ATRIAL SEPTUM

ASD & PFO Closure

Disc-based occlusion and tissue-preserving suture closure concepts.

Mitral valve anatomy with representative transcatheter repair and replacement concepts
MITRAL VALVE

Mitral Therapies

Leaflet approximation and transcatheter replacement concepts for mitral disease.

Tricuspid valve anatomy with a representative transcatheter tricuspid implant
TRICUSPID VALVE

Tricuspid Therapies

Catheter-based repair and replacement concepts designed for right-heart anatomy.

Educational illustrations are generic and are not depictions of any specific manufacturer’s product. Device selection and treatment decisions require evaluation by a qualified heart team.

Technology platforms

Innovation across the structural heart continuum.

Our focus spans valve replacement, repair, occlusion, and closure systems—grounded in anatomy, procedural reality, and meaningful clinical need.

01 · AORTIC

Transcatheter Aortic Valve Replacement

Concepts for valve performance, anchoring, sealing, commissural alignment, coronary access, delivery systems, and lifetime management.

TAVRDelivery systemsHemodynamics
02 · LEFT ATRIUM

Left Atrial Appendage Occlusion

Approaches to adaptable fixation, complete sealing, lower device footprint, procedural simplicity, and anatomy-responsive closure.

LAAOAnchoringConformability
03 · SEPTAL

Atrial Septal Technologies

Transcatheter and suture-based concepts for ASD and PFO closure with attention to tissue preservation and future access.

ASDPFOSuture-based
04 · MITRAL

Transcatheter Mitral Technologies

Replacement and repair concepts addressing annular complexity, LVOT interaction, sealing, anchoring, and deliverability.

TMVRRepairReplacement
05 · TRICUSPID

Transcatheter Tricuspid Technologies

Systems designed around large, dynamic anatomy, variable leaflet geometry, right-heart physiology, and venous access.

TTVRTEER conceptsRight heart
Development approach

From unmet need to testable concept.

A disciplined pathway links clinical insight to engineering development while keeping usability, anatomy, and safety at the center.

01

Define the need

Identify a consequential clinical or procedural limitation worth solving.

02

Design around anatomy

Translate imaging, biomechanics, and procedural constraints into requirements.

03

Prototype & iterate

Develop concepts, assess failure modes, and refine through structured testing.

04

Build the evidence path

Prepare for verification, preclinical evaluation, regulatory strategy, and translation.

HF

Human factors begin at the first sketch.

Delivery, visualization, deployment, repositioning, retrieval, and workflow should be designed as one integrated clinical experience—not addressed after the device is built.

Core capabilities

Clinical insight translated into engineering direction.

Structural Heart Innovations brings a procedural lens to early-stage device strategy, concept definition, and development planning.

01

Clinical needs assessment

Procedural pain points, patient selection gaps, anatomical limitations, workflow friction, and complication-driven opportunities.

02

Concept and design input

Physician-led product requirements, delivery concepts, deployment sequences, and usability priorities.

03

Imaging and anatomical strategy

CT, echocardiographic, fluoroscopic, and access considerations integrated into device architecture.

04

Translational planning

Bench-test logic, preclinical questions, risk framing, clinical endpoints, and development milestones.

05

Strategic collaboration

Engagement with engineers, inventors, research partners, manufacturers, and development teams.

FELLOWSHIP MASTERCLASS · MODULE 01

Left atrial appendage closure: from anatomy to lifetime management.

The complete advanced module now includes 16 chapters covering guideline-based selection, quantitative CT and TEE, device-specific mechanics, geometry-driven transseptal access, implant troubleshooting, rescue algorithms, antithrombotic pathways, surveillance, trial-level outcomes, and linked primary literature.

Open the comprehensive masterclass →

1. Clinical foundation

In nonvalvular atrial fibrillation, thrombus frequently originates in the left atrial appendage. Percutaneous LAA closure mechanically excludes this trabeculated, low-flow chamber from the systemic circulation. The therapeutic trade is deliberate: accept an up-front invasive procedure and a period of device healing to reduce long-term dependence on oral anticoagulation.

Core objectiveDurable exclusion with stable fixation, minimal residual communication, and no interference with surrounding structures.
Clinical questionIs the lifetime benefit of avoiding anticoagulation greater than procedural and device-related risk?
Heart-team frameStroke risk, bleeding risk, competing mortality, anatomy, medication tolerance, and patient preference all matter.
LAA closure is not simply “an alternative to anticoagulation.”It is a lifetime-management strategy for selected patients; it does not treat atrial fibrillation, symptoms, or non-LAA sources of embolism.

2. Patient selection and indications

Best-aligned clinical profile

  • Nonvalvular AF with meaningful thromboembolic risk and a rationale to avoid indefinite oral anticoagulation.
  • Prior major bleeding, clinically important recurrent bleeding, or a high-risk condition that makes future bleeding likely.
  • Inability to maintain safe anticoagulation because of falls, frailty, occupational risk, adherence barriers, drug interaction, renal dysfunction, or intolerance—after reversible causes are addressed.
  • Ability to complete at least a short post-implant antithrombotic regimen and surveillance imaging.

Do not reduce selection to a score

CHA₂DS₂-VASc estimates thromboembolic risk and HAS-BLED helps reveal modifiable bleeding hazards, but neither substitutes for judgment. Document the bleeding phenotype, its reversibility, expected anticoagulant exposure, life expectancy, frailty, competing stroke mechanisms, and the patient’s goals.

Favors closureRequires deliberationUsually defer / avoid
Prior intracranial hemorrhage; recurrent GI bleeding; major bleeding on appropriate OAC; very high future bleeding riskRemote corrected bleed; isolated preference; severe CKD; active cancer; very elderly or frail patientActive LAA thrombus; infection; incompatible anatomy; inability to take required post-implant therapy; very limited life expectancy
Special populations: mechanical prosthetic valves and moderate-to-severe rheumatic mitral stenosis are not the routine evidence base for percutaneous LAA closure. Image a prior surgical LAA exclusion to define the remnant before considering percutaneous treatment.

3. Anatomy and transseptal strategy

The LAA ostium lies anterolateral to the left superior pulmonary vein and superior to the mitral annulus, with the left circumflex artery and great cardiac vein along its inferior epicardial relationship. Chicken-wing, windsock, cactus, and cauliflower labels are descriptive—not procedural endpoints. What matters is the ostial plane, landing-zone diameter, depth, angulation, lobes, trabeculation, proximal ridge, and relationship to the pulmonary vein and mitral apparatus.

Transseptal puncture is part of device sizing

The puncture determines coaxiality, sheath torque, depth, and deployment force. A posterior-inferior puncture is frequently favorable, but the ideal site is anatomy- and device-specific. Use bicaval and short-axis TEE views, confirm tenting, and assess the trajectory before crossing. An anterior puncture can force oblique deployment; an excessively superior puncture can reduce working depth.

Think in vectorsPuncture → sheath path → device axis → landing zone. Optimize the entire line.
Respect the ridgeThe left lateral ridge separates the LAA from the left upper pulmonary vein and affects ostial definition.
Depth is 3-DMeasure usable depth along the intended deployment axis, not the longest visible 2-D line.

4. Pre-procedural TEE and cardiac CT

TEE acquisition

Interrogate the LAA near 0°, 45°, 90°, and 135° with deliberate gain and depth optimization. Identify thrombus versus spontaneous echo contrast, measure the ostium and intended landing zone, define maximum diameter and usable depth, evaluate lobes, document baseline pericardial space, and inspect the interatrial septum.

CT acquisition and reconstruction

Use ECG-gated cardiac CT with adequate left-atrial opacification; a delayed phase helps distinguish slow flow from thrombus. Reconstruct the ostial plane orthogonal to the LAA axis and measure minimum and maximum diameters, perimeter, area, depth, and morphology. CT often reveals a larger maximal dimension than 2-D TEE because the landing zone is elliptical.

QuestionTEE strengthCT strength
Exclude thrombusReal-time flow and spontaneous contrastExcellent with delayed phase
Size landing zoneDynamic and intraproceduralTrue orthogonal 3-D geometry
Plan punctureDirect procedural guidancePre-plans height and trajectory
Assess sealColor DopplerHigh-resolution position and patency
Fellow checkpoint before entering the labState the intended device family and size range, backup size, ideal puncture, primary fluoroscopic projection, deployment axis, anatomic hazard, and bailout plan.

5. Implant procedure: a disciplined sequence

  1. Team brief and imaging reviewConfirm indication, therapy plan, thrombus exclusion, device strategy, access, anesthesia, renal plan, and rescue equipment.
  2. Venous access and baseline imagingDocument the pre-existing pericardial space and reassess for thrombus before left-atrial instrumentation.
  3. Transseptal punctureUse TEE or ICE plus fluoroscopy, confirm tenting at the planned site, cross safely, and anticoagulate according to protocol.
  4. Sheath deliveryMaintain wire position, de-air meticulously, avoid scraping the atrial wall, and orient toward the intended axis.
  5. Angiography and final sizingReconcile angiography with intraprocedural echo and pre-procedure CT rather than allowing one modality to dominate.
  6. Controlled deploymentPreserve coaxiality and avoid aggressive advancement into thin distal tissue.
  7. Release criteriaConfirm position, fixation, device-specific compression or conformation, acceptable seal, and stability without excessive traction.
  8. Release and exitReconfirm position, mitral and pulmonary venous function, absence of new effusion, hemostasis, medication, and imaging plan.

Device families: mechanism matters

DesignMechanismKey consideration
Single-lobe / plugEndocardial plug seated in a landing zoneDepth, circumferential engagement, compression, and stable proximal position
Lobe-and-discDistal lobe anchors while a proximal disc covers the ostiumDisc orientation, mitral/PV clearance, lobe compression, and ostial coverage

6. Complications: recognition and rescue

ComplicationEarly signalImmediate response
Perforation / tamponadeHypotension, new effusion, chamber collapse, tachycardiaStop manipulation; reverse when appropriate; urgent drainage, blood, and surgical support
Device embolizationLoss of position or visualization in LA, LV, or aortaLocalize and plan snare retrieval versus surgery without worsening obstruction
Air / thromboembolismST change, neurologic deficit, collapse100% oxygen, aspiration when accessible, coronary/cerebral emergency pathway
Peridevice leakResidual color jet or CT patencyCharacterize mechanism and size; optimize before release when feasible
Device-related thrombusMass or hypoattenuated thickeningAnticoagulate when safe and repeat imaging to document resolution
Access bleedingPain, swelling, falling hemoglobinCompression, ultrasound, reversal/transfusion or vascular intervention
Never normalize hypotension after LAA instrumentation.Until proven otherwise, assume perforation, tamponade, bleeding, air embolism, or an acute coronary/vascular event. Re-image immediately.

7. Evidence and landmark trials

The evidence has evolved from warfarin-controlled efficacy trials to contemporary device registries, randomized comparison with DOACs, head-to-head device trials, and ablation-adjacent strategies. Interpret each study by its comparator, device generation, post-implant regimen, operator era, and enrolled bleeding risk.

PROTECT AF

Established proof of concept versus warfarin, with long-term thromboembolic protection but an early procedural safety penalty from the first-generation era.

PREVAIL

Added randomized warfarin-comparator evidence and improved procedural safety while highlighting endpoint and noninferiority nuances.

PRAGUE-17

Directly compared closure with DOAC therapy in high-risk patients and supported noninferiority for a composite of ischemic, bleeding, and procedural outcomes.

PINNACLE FLX

Prospective evaluation showing high implant success and favorable seal with the redesigned Watchman FLX platform; nonrandomized.

Amulet IDE

Randomized Amulet versus Watchman: noninferior safety and effectiveness with superior anatomic closure, balanced against device-specific procedural considerations.

OPTION

After AF ablation, closure reduced clinically relevant nonprocedural bleeding and was noninferior for death, stroke, or systemic embolism versus anticoagulation.

How to read the literature

  • Separate procedural safety from long-term ischemic efficacy and bleeding benefit.
  • Do not extrapolate first-generation complication rates directly to contemporary platforms.
  • Count the post-implant antithrombotic regimen as part of the intervention.
  • Examine how leak, device thrombus, cardiovascular death, and disabling stroke were adjudicated.
  • Noninferiority does not mean equivalence for every component or patient phenotype.

8. Post-implant therapy and surveillance

Antithrombotic therapy must follow current device labeling, the evidence-supported regimen, and the patient’s bleeding and thrombotic risk. Contemporary strategies may use short-term anticoagulation plus aspirin or dual antiplatelet therapy in selected circumstances. No single regimen is universal.

Surveillance questions

  • Is the device stable and in the intended position?
  • Is there device-related thrombus?
  • Is the appendage excluded, and what is the mechanism and magnitude of residual leak?
  • Is there effusion or interaction with the mitral valve or pulmonary veins?
  • Can therapy be de-escalated safely, or is treatment and repeat imaging required?

TEE or cardiac CT is commonly performed during early follow-up, with timing determined by labeling, regimen, protocol, and clinical events. New neurologic symptoms, embolism, unexplained dyspnea, chest pain, or bleeding should trigger earlier evaluation.

Selected foundational reading

  1. SCAI/HRS expert consensus statement on transcatheter LAA closure.
  2. PROTECT AF and PREVAIL randomized trials and long-term follow-up.
  3. PRAGUE-17 randomized comparison with direct oral anticoagulation.
  4. PINNACLE FLX prospective device evaluation.
  5. Amulet IDE randomized head-to-head device trial.
  6. OPTION randomized trial after atrial fibrillation ablation.
  7. Current FDA labeling and manufacturer instructions for use for the implanted device.

Educational material for clinicians. It is not a substitute for device-specific training, current instructions for use, institutional protocols, multidisciplinary judgment, or individualized care. Evidence and labeling evolve; verify the current primary source before clinical application. Last educational review: September 2026.

Physician-founder

Innovation shaped by the realities of the procedure room.

Dr. Raj Marok is a board-certified interventional and structural cardiologist with more than a decade of experience in complex coronary intervention, transcatheter valve therapy, left atrial appendage closure, and congenital structural interventions. A Clovis native, he returned to California’s Central Valley after serving as Medical Director of Structural Heart Disease and Co-Director of a complex high-risk PCI and CTO program in West Michigan.

He previously served as an Associate Professor of Medicine at Michigan State University College of Human Medicine and as core faculty for an interventional cardiology fellowship. His advanced interventional training included structural heart, complex coronary, and vascular intervention at Columbia University Medical Center and NewYork-Presbyterian Hospital.

Dr. Marok’s research and development interests center on left atrial appendage closure, transcatheter valve technologies, imaging-guided intervention, and quality improvement. He has served as a principal investigator and sub-investigator in multicenter clinical trials and participated in the world’s first preclinical implant of the WATCHMAN FLX Pro device as part of its FDA approval program.

Structural heart leadershipProgram development, clinical operations, and quality improvement
Academic medicineFormer Associate Professor and fellowship core faculty
Clinical researchPrincipal investigator across LAA closure and structural studies
Advanced trainingColumbia University and NewYork-Presbyterian Hospital

His work is driven by a simple premise: device design should begin with anatomy, workflow, and the unmet needs encountered in real patient care.

For patients & families

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Structural Heart Innovations

Better devices begin with better questions.

We are developing and evaluating new ideas at the intersection of structural heart medicine, device engineering, and procedural innovation.

structuralheartinnovations@gmail.com ↗Research & development · Clovis, California