Control Medical Technology

CONTROL MEDICAL TECHNOLOGY

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.

 

CONTROL MECHANICAL ASPIRATOR™

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.

Control Medical Technology

CONTROL MECHANICAL THROMBECTOMY™

CONTINUOUS & PULSED MECHANICAL THROMBECTOMY

Syringe-based thrombectomy systems offer limited speed, force, volume & control. Electric pump systems may deliver increased force and volume, but many add complexity and cost to the procedure.

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

Squeezing the handles increases force and releasing handles stops it. A one-way valve on the plunger purges air in the barrel to maintain thrombectomy force. A one-way valve on the barrel prevents re-injection of the aspirant. The dual valves and a drain bag combine to create a closed fluid system to eliminate repeated syringe-catheter detachments and drainage.

Control Thrombectomy Catheters may also be connected to electric pumps.

  • Instantly Start, Stop, Increase or Decrease Force
  • Continuous & Pulsed Force
  • Reset Force With Each Release-Squeeze Cycle
  • Closed System…275+ ml Volume Capacity
  • Large-Lumen 5 – 11F Over-the-Wire (OTW) Catheter
  • Large-Lumen Rapid-Exchange (RX) Catheters with removable kink-resistant core wires

 

Control Mechanical Thrombectomy Aspirator is indicated to aspirate fluids from the body and for peripheral and coronary thrombectomy. 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-LP Mechanical Thrombectomy system is indicated for removal of fresh, soft emboli and thrombi from vessels in the peripheral & coronary vasculature. Protected by U.S. and global issued and pending patents.

Control Medical Technology

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


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


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


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


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


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


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


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


* 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.

OUR TEAM

SHAWN FOJTIK
CEO
Park City, Utah USA

LAWRENCE KRONICK
Director of International Sales
Hallandale Beach, Florida USA

TIM NIEMAN
Engineering
Salt Lake City, UT USA

ERIK LIDDIARD
Engineering
Salt Lake City, UT USA

THIAGO HASSEGAWA
Brazil Country Manager
Sao Paulo, Brazil

DIETER HOEVEL
European Manager
Munich, Germany

M.A. SUDHEER
India Country Manager
Bengaluru, India

ALAN YANG
China Manager

DOMINIC YIM
South East Asia
Regional Sales Manger

SHINYA MIIKE
Japan Manager
Tokyo, Japan

SAM KANAZAWA
Japan Manager
Tokyo Japan

CAROLINA GREGORIO
Latin America Sales Manager &
Global Sales Support
Hallandale Beach, Florida USA

CARMEN AGUILERA
Order Administrator & Trade Shows
Hallandale Beach, Florida USA

REIMBURSEMENT FAQ'S

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.

CONTACT US

Shawn Fojtik
CEO
Park City, Utah USA

Shawn Fojtik has (100+) combined issued and pending patents on angiographic, angioplasty, biopsy, embolic, imaging, electrophysiology, tissue resection, thrombectomy, women’s health, and other devices. His background includes sales, marketing, product development, and general management experience at General Electric Medical Systems, Boston Scientific, Black & Decker, and start-ups. Shawn has a Bachelor’s Degree from the University of Illinois in Champaign, Illinois; a Master’s Degree from Harvard University in Cambridge, Massachusetts; and is an Adjunct Assistant Professor of Surgery (non-clinical educator) at the University of Utah in Salt Lake City, Utah.

Lawrence Kronick
Director of International Sales
Hallandale Beach, Florida USA

Lawrence Kronick has over 35-years of operational experience in cardiovascular, interventional radiology, electrophysiology, general surgery, and imaging sales, marketing, and business development. He is the founder of BAC Inc., a consulting company with teams in Miami, Sao Paulo, Tokyo, Hong Kong, Bengaluru, Munich, and Beijing assisting medical device and equipment companies expand and develop global sales distribution. Mr. Kronick speaks Mandarin and English.

Tim Nieman
Engineering
Salt Lake City, UT USA

Tim Nieman holds a BS in Bioengineering from Arizona State University and has more than two decades of experience in medical device development. His experience includes roles with CR Bard, Worldheart, and Edwards Lifesciences. His accomplishments include device commercialization for cardiovascular stents, catheters, wires, LVADs, and ablation devices. He has 7 issued or pending patents.

Erik Liddiard
Engineering
Salt Lake City, UT USA

Erik Liddiard, holds a BS in Bioengineering and an MS in Mechanical Engineering from University of Utah with over 12 years’ experience in medical devices and pharma. Mr. Liddiard has led the development of more than 5 devices and has contributed to Control Medical’s and Distal Access's intellectual property.

Carolina Gregorio
Latin America Sales Manager &
Global Sales Support
Hallandale Beach, Florida USA

Carolina Gregorio has 20-years’ experience in international trade, marketing, and logistics with BAC Inc. and ICI Paints (UK). Carolina received a graduate degree in Corporate Logistics Management from the Argentine Business University. Ms. Vance is fluent in Spanish, English, and Portuguese.

Thiago Hassegawa
Brazil Country Manager
Sao Paulo, Brazil

Thiago Hassegawa is native to Brazil and he received his Electronic Engineering degree from Universidad Federal De Itajuba of Sao Paulo State University. Mr. Hassegawa spent over 6 years in service and sales at Phillips and CMS Produtos Médicos where he serviced and sold both capital equipment and disposable medical products. Thiago provides valuable in country experience and knowledge and speaks both English and Portuguese.

M.A. Sudheer
India Country Manager
Bengaluru, India

M.A. Sudheer has 13 years of Healthcare industry experience in India. His professional career started as a sales executive for Aloka Ultrasound in Northern India and subsequently grew into a Managerial position. Following Aloka, Sudheer was responsible for marketing NIC products (Mortara and Del Mar Reynolds) and critical care products in different positions with reputed companies before moving to Spacelabs Healthcare as a Sales & Marketing Manager.

Dieter Hoevel
European Manager
Munich, Germany

Dieter Hoevel is based in Germany and has over 30 year of experience in the medical device industry. He has been involved in successful medical device start-up companies, such as Micrus, Acandis and Neoventa. Previously he worked with Boston Scientific Corporation, Cordis and B. Braun in various sales, marketing, and general management roles. During this time, he worked in EMEA in senior positions including Vice-President Sales & Marketing for Straub Medical. Mr. Hoevel is fluent in German, English, French and Dutch.

Alan Yang
China Manager

Alan Yang graduated from the China Civil Aviation College with a degree in engineering and has over twenty years of medical equipment sales experience in China. Alan specializes in the development and implementation of sales and marketing programs for our client’s product portfolios in the China market. Since 1985, Alan has introduced a variety of advanced medical technologies to China including products from Cook, Medtronic, Bausch & Lomb, Stryker, Picker International and Philips. Mr. Yang is fluent in both English and Mandarin Chinese.

Shinya Miike
Japan Manager
Tokyo, Japan

Shinya has over 25-years of experience in the medical device business in Japan particularly in the field of endoscopic medicine. He has developed and marketed new types of endoscopes and invested in several Venture companies who have developed various new medical devices He has developed strategies and tactics for penetrating Japanese medical markets and established new surgical techniques. Shinya is also a pioneer in the ultra-thin endoscopic field (under 1mm outer diameter) for ophthalmology, breast surgery and Cardiology. Shinya received 1st Prize at the Tokyo Technology Venture Awards in 2004.

Sam Kanazawa
Japan Manager
Tokyo Japan

Osamu (Sam) Kanazawa resided in the USA for 7 years and has an undergraduate degree from Franklin and Marshall College and an MBA from Bond University in Australia. He has over thirty years of medical marketing experience in Japan. Sam began his career with American Hospital Supply and has had positions in many large international companies, including Beckman Instruments, Boston Scientific, Jomed, and St. Jude Medical. Sam also worked for a number of Japanese companies including a thin fiber endoscope company called FiberTech.

Carmen Aguilera
Order Administrator & Trade Shows
Hallandale Beach, Florida USA

Carmen Aguilera manages global order administration, press, and trade show activities.

Dominic Yim
South East Asia
Regional Sales Manger

Mr. Dominic Yim has previously worked as senior sales and HR executives at major global healthcare and medical device companies - Thermo-Fisher, Philips Healthcare, Medtronic, Steris, Siemens-Acuson, Abbott- St. Jude Medical Inc. and Biosensors International Group. Dominic also provided consulting services for GE Medical, J&J, SonoSite, Boston Scientific, Getinge Healthcare Group.
With 35 years of leadership in the medical device industry, Dominic has always been involved in the introduction of advanced medical technologies into the China and Asian markets. These technologies included medical imaging, interventional medicine, infection control and cardiac devices.
Dominic’s career in medical device has taken him to countries such as China, Hong Kong, Korea, Taiwan, Singapore, Japan, India, Australia, Switzerland, Canada and the USA. Dominic currently resides in Hong Kong and in fluent in Mandarin, Cantonese and English.