WELCOME

Thrombectomy needs vary based on the size, location, and age of thrombus.

Sometimes subtle low force is needed, other times full-force is required. Certain procedures benefit from continuous force…other procedures only need a quick spot, or touch-up, targeted force. Yet in other situations, pulsed force to rapidly cycle between full and no force is required.

Basic syringe-based systems lack this versatility as syringes offer limited force, control, & volume. Typically, syringes only fill 30ml at a time requiring repeated attachment, stopcock manipulation, filling, detachment, drainage, and re-attachment to catheters. Slow, messy, risky, and inefficient.

Electromechanical systems may deliver more force and volume than basic syringes, but add complexity and cost to the procedure with limited tactile feel and control.

The Control Mechanical Thrombectomy System delivers new control during thrombectomy. Users instantly start, stop, increase, decrease, maintain, and pulse thrombectomy force.

Mechanical Thrombectomy made easy.

ABOUT US

Control’s technology has safely been used in 10s of thousands of patients to remove blood clots from the heart, legs, arms, abdomen, and brain.

The company is committed to quality in all business operations. Control Medical is registered with the United States Food and Drug Administration and works with ISO 13485:2008 certified vendors.

Control Medical has offices in Park City, Utah, Salt Lake City, Utah, and Hallandale Beach, Florida, USA.

 

Electromechanical systems can provide high aspiration force and volume, but are expensive, difficult to set up, require training, require service, and do not let the clinician feel or control aspiration like a hand-held device.

Small syringes are easy to operate but are limited in aspiration volume and will lose aspiration force quickly if air enters into the needle, catheter, trocar, or tube through cavitation, degassing, or connectivity leakage.

Large syringes can aspirate more volume and are less susceptible to loss of force if air enters the barrel, but are difficult to operate requiring two hands to pull the plunger back.

All standard syringes lack the ability to quickly purge air that enters into the circuit , allow the user to instantly increase or decrease force without accidentally re-injecting the aspirant, or perform pulsed aspiration.

CODE: ARX-LP6
NAME: Control RX-LP Mechanical Thrombectomy*
TYPE: Rapid-Exchange
CROSSING/SHAFT: 0.020"/0.054"
SHEATH: 5F
GUIDE CATH: 6F
GUIDE WIRE: 0.014
WORKING LENGTH: 136cm

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CODE: A5-135
NAME: Control 5F Mechanical Thrombectomy*
TYPE: Over-the-Wire
CROSSING/SHAFT: 0.065"/0.065"
SHEATH: 5F
GUIDE CATH: N/A
GUIDE WIRE: 0.035
WORKING LENGTH: 135cm

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CODE: A6-135
NAME: Control 6F Mechanical Thrombectomy*
TYPE: Over-the-Wire
CROSSING/SHAFT: 0.075"/0.075"
SHEATH: 6F
GUIDE CATH: N/A
GUIDE WIRE: 0.035
WORKING LENGTH: 135cm

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CODE: A7-090
NAME: Control 7F Mechanical Thrombectomy**
TYPE: Over-the-Wire
CROSSING/SHAFT: 0.050"/0.090"
SHEATH: 7F
GUIDE CATH: N/A
GUIDE WIRE: 0.035
WORKING LENGTH: 90cm

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CODE: A9-090
NAME: Control 9F Plus Mechanical Thrombectomy**
TYPE: Over-the-Wire
CROSSING/SHAFT: 0.050”/0.112"
SHEATH: 8F/9F (Compatible with 8F 10cm Terumo Pinnacle Sheath)
GUIDE CATH: N/A
GUIDE WIRE: 0.035
WORKING LENGTH: 90cm

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CODE: A11-090
NAME: Control 11F Mechanical Thrombectomy**
TYPE: Over-the-Wire
CROSSING/SHAFT: 0.050"/0.140"
SHEATH: 10F/11F (Compatible with 10F 10cm Terumo Pinnacle Sheath)
GUIDE CATH: N/A
GUIDE WIRE: 0.035
WORKING LENGTH: 90cm

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CODE: 30-ASP
NAME: Control Mechanical Aspirator
Compatible with any thrombectomy catheter

CODE: A11-090
NAME: Control 10F Plus Mechanical Thrombectomy**
TYPE: Over-the-Wire
CROSSING/SHAFT: 0.050"/0.140"
SHEATH: 10F
GUIDE CATH: N/A
GUIDE WIRE: 0.035
WORKING LENGTH: 90cm

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CODE: 30-ASP
NAME: Control Mechanical Aspirator
Compatible with any thrombectomy catheter

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* Includes (1) Control Mechanical Aspirator and (1) Over-the-Wire (OTW) or Rapid-Exchange (RX) Thrombectomy Catheter.
** Includes (1) Control Mechanical Aspirator, (1) OTW Thrombectomy Catheter, and (1) dilator.

What are the indications for use for Control Medical Technology’s devices?

• Control 5 – 11F Mechanical Thrombectomy Systems are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. 
• Control RX-LP6 Mechanical Thrombectomy System is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral and coronary vasculature. 
• Control Mechanical Aspirator is indicated for the…
• Removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature,
• Removal of fresh soft emboli and thrombi from vessels in the coronary vasculature,
• Use as a syringe to aspirate fluids from the body.  

See instructions for use of each device for indications, contraindications, warnings, cautions, and other information.

Does a Control Mechanical Thrombectomy procedure have a HCPCS (Level II) or C-Code?
The following Control Medical Technology’s devices are FDA cleared, registered, and used in thrombectomy and embolectomy procedures:

• Control RX-LP6 Mechanical Thrombectomy System = C1757
• Control 5F Mechanical Thrombectomy System 135cm = C1757
• Control 6F Mechanical Thrombectomy System 135cm = C1757
• Control 7F Mechanical Thrombectomy System 60 and 90cm = C1757
• Control 8F Mechanical Thrombectomy System 60 and 90cm = C1757
• Control 9F Mechanical Thrombectomy System 60 and 90cm = C1757
• Control 10F Mechanical Thrombectomy System 60 and 90cm = C1757
• Control 11F Mechanical Thrombectomy System 60 and 90cm = C1757
• Control Mechanical Aspirator = A4213

The Control RX-LP6 Mechanical Thrombectomy System, Control 5-11F Mechanical Thrombectomy Systems, and the Control Mechanical Aspirator may be used in office-based-labs (OBLs), ambulatory surgical centers (ASC), clinics, and/or in hospitals as inpatient or outpatient procedures.  Accordingly, Control Medical Technology references established Coding (CPT, ICD-10 PCS, ICD-10 CM) for numerous procedures and point-of-care settings including arterial and venous mechanical thrombectomy and embolectomy.      

• Inpatient: 
• If mechanical thrombectomy is performed as a hospital inpatient procedure, then reporting of a HCPCS or C-Code for billing purposes is typically not required, as it would be with “outpatient” services.  
• Device reimbursement is included as part of the DRG payment. 
• DRG payments do not provide for more reimbursement if a more expensive device(s) are used for the same procedure. 
• Control Medical Technology’s platform typically cost the hospital less than competitive alternatives.  It is in the patients’ and hospitals’ to buy the best device for the patient at the lowest possible price.

• Outpatient: 
• If mechanical thrombectomy is performed as an outpatient procedure, C1757 (thrombectomy catheter) can be used to account for the device in addition to any relevant Common Procedure Terminology (CPT) Codes for the thrombectomy procedure (i.e.: if mechanical thrombectomy is performed, then CPT Code 37184/37185 for an arterial mechanical thrombectomy or CPT Code 37187 for a venous mechanical thrombectomy may apply). 
• However, there is no additional payment for C1757, as they are included within the overall Medicare Comprehensive APC payment for the thrombectomy procedure.
• Outpatient procedure payments do not provide for more reimbursement if more expensive device(s) are used for the same procedure. 
• Control Medical Technology’s platform typically cost the outpatient provide less than competitive alternatives.  It is in the patients’ and outpatient service providers’ interest buy the best device for the patient at the lowest possible price.     

Does my provider need to state “Extirpation of Matter” when dictating for procedures using the Control Mechanical Thrombectomy systems?
The definition for the root operation Extirpation is “taking or cutting out solid matter from a body part.” 

While it is not necessary for a physician to say the term “extirpation” when describing a thrombectomy or embolectomy, it accurately describes the root operation for the inpatient procedure performed when thrombectomy and/or embolectomy is performed.  Hospital inpatient coders use the definition of the root operation as well as the dictation and procedure documentation to determine that a thrombectomy and/or embolectomy is a type of extirpation, and that you are “removing” or “taking out” clot, thrombi, and/or emboli from the respective body part.

What is the 2-Midnight Stay Rule?
Based on the Medicare 2-Midnight Stay Rule, there is a requirement that hospital inpatient stays must be greater than or equal to 2 midnight stays in order to be eligible for Medicare inpatient reimbursement. A physician order to admit the patient is required, based on clinical necessity and documentation.  If the patient stays less than two midnights and is discharged same day or next day, in most cases, this is considered a hospital outpatient stay.

Disclaimer: The coding and payment information contained is publicly available from third party sources and Control Medical Technology is providing it for general informational purposes only.  The coding information, payment information, and/or procedure codes provided are not an all-inclusive list, and they are not intended, and do not constitute legal, reimbursement, or business advice. The information is not a promise or guarantee by Control Medical Technology regarding actual payment rates that providers will receive for any given service. Similarly, all CPT®, ICD-10 and HCPCS codes are supplied for informational purposes only and represent no statement or guarantee by Control Medical Technology that these codes are appropriate to specific circumstances or products or services provided to an individual patient or that the services will be covered. It is the health care provider’s responsibility to accurately report the patient diagnosis, the services provided, and the procedures performed, consistent with the payer’s guidelines. Likewise, site of service decisions (e.g., inpatient or outpatient) are based on medical necessity and should be determined by the physician in consultation with the patient and consistent with any payer guidelines or licensing provisions. If providers have questions about coverage, coding, or payment, providers should consult the specific payers. The Centers for Medicare and Medicaid Services (CMS) website is available at https://www.cms.gov/Medicare/Medicare.html. Reimbursement is dynamic and payment rates change. New codes are added, and existing codes may be revised. Coverage policies and payment amounts also change. The information contained in this document is current as of the date of publication. CPT® Copyright 2021 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.