Products
What is included?
Six product families covering exposure, stabilization, positioning, suture management, and anastomotic field support.
Cardiac Surgery Product Portfolio
Cardiac surgery devices for OPCAB and selected MICS / MIDCAB workflows.
Six product families for surgical exposure, beating-heart stabilization, suture management, and anastomotic field support.
AeroMed Surgical brings disposable and reusable cardiac surgery configurations together in one customer-facing portfolio. Product selection, permitted combinations, regulatory documentation, and target-market availability are confirmed by product and model scope.
Final product selection and use should follow the current IFU, surgeon assessment, institutional protocol, and target-market requirements.
6 Product FamiliesOne cardiac portfolio overview
Disposable + ReusableDifferent stabilization pathways
OPCAB + Selected MICS/MIDCABConfiguration-led evaluation
ISO 13485One manufacturing quality system
Quick Answer
What should a distributor or cardiac team understand first?
The page separates product function, configuration choice, and regulatory status so that reusable frames, disposable stabilizers, working ends, exposure products, and support products are not treated as one undifferentiated “suite.”
Selection
How do I choose?
Start with surgical approach, reusable-versus-disposable preference, mounting arrangement, compatible working end, and required documentation.
Regulatory
Do all products share one CE or FDA status?
No. Regulatory wording is shown separately for each product family and exact model scope.
Evaluation
What can I request?
Model matrices, IFU and labeling information, available certificates, catalogs, samples, product training, and quotation support.
Product Architecture
Three functional groups—not a mandatory five-step surgical sequence.
The portfolio is organized around what each product does. Hospitals and distributors can evaluate one product family, a selected configuration, or a broader portfolio according to local needs.
Surgical Exposure
Access to the operative field
Reusable sternal retraction for selected open cardiac procedures and compatible instrument workflows.
Stabilization & Positioning
Disposable and reusable configuration pathways
Single-use stabilizer systems, reusable support frames, and compatible SF working ends should be selected as separate but related product elements.
Procedural Support
Suture and field-support products
Independent support products for selected cardiac workflows, with product-specific IFU and regulatory documentation.
Six Product Families
Choose the product page that matches your evaluation need.
Each page should be used to confirm models, configuration logic, intended use, packaging, and current regulatory-document scope.
Disposable Stabilization System
Heart Stabilizer System
HK-Fy · HK-Fy-R(II) · HK-Yg / HK-Zg transition references
Single-use standoff configurations combined with compatible SF working ends for documented OPCAB and selected minimally invasive cardiac workflows.
Public regulatory wording
CE Class IIIFDA Listed · 510(k)-Exempt
View models & documentation→
Reusable Support Frame
Reusable Stabilizer Frame
HK-GDQ-Q · HK-GDQ-Z
Reusable adjustable ball-joint and straight-rod frame configurations for compatible cardiac stabilization and positioning workflows.
Public regulatory wording
CE MDR Class I · Reusable
Compare reusable configurations→
Tissue-Contact Working Ends
Stabilizer Foot Family
SF-III · SF-IV · SF-V · SF-VII
Vacuum, mechanical, and apical-positioning working-end configurations. Permitted combinations should be confirmed against the current IFU and model documentation.
Public regulatory wording
CE · Heart Stabilizer component scope
Compare working ends→
Surgical Exposure
Sternal Retractor
HK-SR
Reusable sternotomy retractor for selected open cardiac procedures and compatible AeroMed instrument workflows.
Public regulatory wording
CE MDR Class I · Reusable
View product page→
Suture Management
Disposable Suture Holder
HK-FXG · T4 · T8 · Q configurations
Single-use suture-management products, including selected configurations associated with documented stabilizer-mounting workflows.
Public regulatory wording
CE documentation · Model scope
View models→
Anastomotic Field Support
Surgical Blower / Mister
HK-CWG
Single-use blower / mister configurations for selected cardiac surgical field-support workflows according to the current IFU.
Public regulatory wording
CE documentation · Model scope
View models & IFU scope→
Stabilizer Selection Guide
Compare configuration pathways before requesting samples.
This table is a procurement and technical-discussion guide. It does not replace the current IFU, surgeon assessment, institutional protocol, or regulatory review.
| Evaluation Need | Support Structure | Compatible Working End | Mounting Discussion | What to Confirm |
|---|---|---|---|---|
| Classic sternotomy OPCAB | HK-Fy / HK-Fy-R(II) single-use standoff configurations | Compatible SF working end selected by documented workflow | Selected HK-FXG-Q and compatible AeroMed mounting arrangement where applicable | Exact model, standoff type, foot configuration, IFU, packaging, and target-market documentation |
| Reusable stabilization pathway | HK-GDQ-Q adjustable ball-joint frame or HK-GDQ-Z straight-rod frame | Compatible SF working end | Bedside support / table-side mounting arrangement; HK-GDQ does not require the disposable suture holder as its mounting base | Reusable-frame model, working-end interface, mounting hardware, reprocessing documentation, and regulatory scope |
| Selected MICS / MIDCAB evaluation | HK-Yg / HK-Zg commercial references; MDR documentation may use HK-Fy-Yg / HK-Fy-Zg | Compatible SF working end | Compatible table-side holding arrangement to be confirmed during technical evaluation | Access approach, working length, mounting path, labeling name, IFU, and target-market documents |
Naming transition: commercial references HK-Yg and HK-Zg may appear as HK-Fy-Yg and HK-Fy-Zg in MDR documentation. Confirm the exact labeling and document set before quotation, registration, or customer submission.
Clinical Workflow Configurations
Use scenarios to guide product evaluation—not to prescribe surgery.
The following modules help distributors and clinical teams identify which product information to request. They do not provide procedural instructions or clinical outcome claims.
Configuration 01
Standard sternotomy OPCAB discussion
Evaluate the relationship between surgical exposure, single-use stabilization, compatible SF working ends, suture management, and field-support products.
- HK-SR Sternal Retractor
- HK-Fy / HK-Fy-R(II) pathway
- Compatible SF foot selection
- HK-FXG and HK-CWG as separate support products
Configuration 02
Lateral or posterior target exposure discussion
Review whether a positioning configuration and a separate local stabilization configuration are required for the intended workflow.
- SF-VII apical-positioning discussion
- SF-III / SF-IV local stabilization discussion
- Single-use or reusable support structure
- Institutional protocol and surgeon assessment remain decisive
Configuration 03
Selected MICS / MIDCAB evaluation
Confirm working length, access route, table-side mounting arrangement, compatible working end, and model-specific documentation before evaluation.
- HK-Yg / HK-Zg commercial references
- MDR naming transition check
- Compatible holding arrangement
- Target-market registration review
Clinical-use boundary: Final device selection, mounting, handling, and procedural use should follow the current IFU, surgeon assessment, training requirements, institutional protocol, and applicable local regulation.
Regulatory Documentation
Different product families follow different regulatory pathways.
The portfolio is manufactured under one ISO 13485 quality system, but this does not mean all six products share one CE certificate, one device class, or one FDA pathway.
| Product Family | Public Status | Documentation Boundary | Detail Page |
|---|---|---|---|
| Heart Stabilizer System | CE Class III · FDA Listed / 510(k)-Exempt | Confirm exact standoff, working-end, labeling, and market scope. Do not describe FDA listing as FDA approval. | View |
| Reusable Stabilizer Frame | CE MDR Class I · Reusable | HK-GDQ-Q and HK-GDQ-Z reusable-frame scope; reprocessing documentation required. | View |
| Stabilizer Foot Family | CE · Heart Stabilizer component scope | Confirm permitted combinations and intended function for SF-III / IV / V / VII. | View |
| Sternal Retractor | CE MDR Class I · Reusable | Confirm model, accessory, reprocessing, and current certificate scope. | View |
| Disposable Suture Holder | CE documentation · Model scope | Separate suture-management function from selected mounting-interface configurations. | View |
| Surgical Blower / Mister | CE documentation · Model scope | Confirm current models, functional wording, IFU, packaging, and market scope. | View |
Certificate numbers, declarations, IFU, labels, model lists, and available verification documents can be supplied to qualified partners according to the relevant product and market.
Distributor Evaluation
Move from product interest to a documented evaluation package.
The page should lead to a practical next step—not just a general contact form.
01
Product & Model Matrix
Six product families, current models, configuration relationships, and transition naming where applicable.
02
Regulatory Document List
Applicable CE, FDA-listing, IFU, label, declaration, and target-market documentation.
03
Sample & Training Plan
Evaluation quantities, product demonstration, mounting discussion, and distributor training requirements.
04
Market Launch Discussion
Registration pathway, hospital targets, commercial model, documentation responsibility, and next milestone.
Clinical Resources & Insights
Continue from portfolio overview to product-specific education.
Use these pages to understand product relationships, model boundaries, and selected workflow discussions before requesting technical documents.
Insight
Dual-Stabilizer OPCAB for Lateral-Wall Exposure
Configuration logic for positioning and local stabilization discussions.
Insight
Surgical Blower / Mister in OPCAB
Field-support function and public claim boundaries.
Product
Heart Stabilizer System
Standoff families, surgical approaches, and regulatory status.
Product
Stabilizer Foot Family
SF-III, SF-IV, SF-V, and SF-VII working-end differences.
Frequently Asked Questions
Common distributor and clinical-team questions.
What products are included in the AeroMed cardiac surgery portfolio?
The portfolio includes Heart Stabilizer System, Reusable Stabilizer Frame, Stabilizer Foot Family, Sternal Retractor, Disposable Suture Holder, and Surgical Blower / Mister.
What is the difference between the disposable Heart Stabilizer and HK-GDQ?
The Heart Stabilizer is a single-use stabilization system. HK-GDQ is a reusable support frame available in adjustable ball-joint and straight-rod versions. The correct option depends on the access approach, mounting arrangement, reusable-versus-disposable preference, compatible working end, and current documentation.
Which stabilizer feet are available?
SF-III and SF-IV are vacuum stabilization configurations, SF-V is a mechanical stabilization configuration, and SF-VII is used for apical-positioning discussions. Permitted combinations should be confirmed against the current IFU and model documentation.
Does AeroMed support OPCAB and MICS / MIDCAB configurations?
Yes, the portfolio includes configurations for classic sternotomy OPCAB and selected MICS / MIDCAB evaluation. Exact product combinations, working lengths, mounting arrangements, and target-market documentation should be confirmed before evaluation.
What is the FDA status of the Heart Stabilizer?
The Heart Stabilizer is presented as FDA listed under Product Code MWS and 510(k)-exempt. This is not an FDA approval claim. Current FDA records should be checked before commercial use.
What regulatory documents can distributors request?
Qualified partners can request the cardiac product matrix, available CE documentation, FDA-listing information where relevant, IFU and labeling information, declarations, packaging details, catalogs, and target-market support documents.
How can a hospital or distributor arrange product evaluation?
Contact AeroMed Surgical with the target country, preferred product family, surgical workflow, model interest, evaluation quantity, and documentation requirements. A model-specific evaluation package can then be prepared.
Evaluating AeroMed cardiac surgery products?
Request the cardiac product matrix, model-specific regulatory-document list, catalog, sample quotation, and product-training pathway for your target market.