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AMI Pre Aspire Mechanical Thrombectomy Control Medical Technology

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Post AMI Aspire Mechanical Thrombectomy Control Medical Technology

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Control Medical TechnologyNEWS
 
New Medical Device Removes Large Blood Clot From Patient’s Heart
September 8, 2014

Park City, Utah USA –– Dr. Lee Butterfield M.D., interventional cardiologist with Palmetto Cardiology in Columbia, South Carolina, was the first to use a new mechanical thrombectomy (blood clot removal) system to extract a 1 inch long blood clot from a saphenous vein to coronary artery bypass graft.

The patient presented with a long blood clot in an aged saphenous vein bypass graft diagnosed during a cardiac catheterization procedure. Dr. Butterfield used the combination of a protective filter, the new ASPIRE RX-LP6 Mechanical Thrombectomy System, and a stent to remove blood clots and dilate the stenosis.

“Compromised bypass grafts may include long viscous blood clots and emboli making them particularly difficult to treat,” said Lee Butterfield, MD with Palmetto Cardiology. “The ASPIRE RX-LP6 System allowed us to create continuous thrombectomy force and remove a long blood clot from the patient’s vein graft. Once the blood clot was removed, we could better define a culprit lesion and deploy a 3.5mm diameter stent.”

The ASPIRE Systems allow clinicians to instantly start, stop, increase, decrease, pulse, or maintain thrombectomy force during the procedure. ASPIRE Mechanical Aspirators also aspirate up to 280ml, almost 10 times more than basic syringe systems, without multiple messy and time-consuming catheter connections, disconnections, and re-connections.

“The ASPIRE RX-LP6 Mechanical Thrombectomy System is a natural extension to the successful ASPIRE platform,” said Shawn Fojtik, CEO of Control Medical Technology. “Thousands of ASPIREs have been sold and used in procedures from the ankle to the elbow. Adding FDA cleared coronary thrombectomy catheters allows clinicians to bring high-performance mechanical thrombectomy to the heart and improve patient care.”

The patented ASPIRE RX-LP6 Mechanical Thrombectomy System includes an ASPIRE Mechanical Aspirator (drive unit/pump) and a low-profile rapid-exchange (RX) thrombectomy catheter. ASPIRE Mechanical Aspirators are also available alone and may be connected to any thrombectomy catheter the clinician chooses to use. Control Medical also manufactures ASPIRE MAX Mechanical Thrombectomy Systems with larger over-the-wire (OTW) thrombectomy catheters for use in the peripheral vasculature.

Control Medical Technology designs, develops, and markets innovative thrombus (blood clot) management, biopsy, and aspiration devices, including the patented ASPIRE Mechanical Aspirator™, ASPIRE RX-LP6 Mechanical Thrombectomy System™, and ASPIRE MAX Thrombectomy System™, and other devices to improve patient care. For more information about Control Medical, call (954) 534-9345 or visit www.CONTROLMEDTECH.com.

Control Medical Media contact:
Chris Livingstone
(954) 534-9345
Chris@ASPIRATIONMEDICAL.com
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FDA Clears New Mechanical Blood Clot Removal System For Coronary & Peripheral Vasculature
September 5, 2014

PARK CITY, UTAH – Control Medical Technology, Park City, Utah, announced the FDA cleared, and the company began shipping, the new ASPIRE RX-LP6 Rapid-Exchange Mechanical Thrombectomy System™ to remove fresh blood clots and emboli from coronary and peripheral vasculature.

Blood clot removal, or thrombectomy, is performed throughout the body.  The procedure typically involves introducing a small catheter into a patient’s leg, advancing the catheter tip to the target organ / blood clot, and creating aspiration force with a basic syringe or electromechanical pump.

“Blood clots are not homogenous and clinicians need a tool box of solutions to meet patient needs,” said Shawn Fojtik, President of Control Medical Technology.  “The ASPIRE RX-LP6 System is an important step forward to improve thrombectomy speed, control, volume, and performance.”

When removing blood cots, sometimes subtle low thrombectomy force is needed, other times continuous, increased, and/or pulsed force is required. Basic syringes-based thrombectomy devices lack this versatility and many clinicians complain when syringes loose aspiration force as their barrels start to fill with fluid.

In addition, basic syringes typically aspirate only 30ml at a time requiring the clinician to repeatedly connect, disconnect, and re-connect syringes.  This sequence is slow, inefficient, prone to complications, and can increase staff biohazard risk.

Electromechanical pumps can create pulsed and/or continuous aspiration force, but can be complex, require the hospital to purchase expensive capital equipment, commit to service contracts, and cost significantly more per-patient than basic syringe systems.

“ASPIRE technology allows users to instantly start, stop, increase, decrease, maintain, and/or pulse thrombectomy force with a simple user interface and no capital equipment,” continued Fojtik.  “The ASPIRE system has been used as a primary thrombectomy tool and in situations where syringe based devices fail.  We feel privileged to play a role in improve patient care during a wide range of procedures and look forward to adding more catheters to the line.”

Control Medical Technology’s ASPIRE Mechanical Thrombectomy System is now one of the largest FDA cleared platforms in the United States with over-the-wire and rapid-exchange catheters powered by a novel mechanical thrombectomy driver/pump.  The platform is protected by 10+ issued and pending patents.

For more information about Control Medical, call 1-954-534-9345 or visit www.CONTROLMEDTECH.com, Park City, Utah.

Media Contact:
Chris Livingstone
Chris@aspirationmedical.com

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Mechanical Blood Clot Removal System Helps Clean Up Patient’s Leg

Park City, Utah - Andre Bouhasin, MD, an Interventional Cardiologist with West County Heart and Vascular Diagnostics, St. Louis, Missouri used a novel device to remove blood clots and emboli from a protective filter and native arteries to restore blood flow in a patient’s leg.

The patient presented with leg pain after having two arterial stents previously placed in their leg. After an angiogram revealed fresh clot inside the stents, the physician decided to place a protective arterial filter and perform aspiration atherectomy to restore flow.

Arterial filters are small protective baskets that capture clots and atherectomy is a procedure to remove occlusive plaque from a vessel. If a protective filter completely fills with emboli, the filter can be difficult to remove without risking downstream embolization.

“During this procedure, the large amount of blood clot and emboli in the vessel quickly filled the filter,” said Dr. Bouhasin. “We decided to use an ASPIRE MAX 5 Mechanical Thrombectomy System to selectively remove emboli in the filter and then aspirate additional blood clots from the vessel. The ASPIRE system was easy-to-use and allowed us to remove a significant amount of clot and emboli.“

The ASPIRE Mechanical Thrombectomy System allows clinicians to instantly start, stop, increase, decrease, pulse, or maintain thrombectomy force during a procedure. ASPIRE Mechanical Aspirators also aspirate up to 280ml, almost 10 times more than basic syringe-based systems, without multiple messy and time-consuming catheter connections, disconnections, and re-connections to improve speed and performance.

“The ASPIRE MAX 5 Mechanical Thrombectomy System can improve performance during a variety of procedures,” said Shawn Fojtik, CEO of Control Medical Technology. “Selectively removing large clot burden is not easy. ASPIRE technology meets this challenge by giving clinicians more thrombectomy force control with improved volume and speed. ASPIRE can be an economic win too for the institution costing less than other thrombectomy systems with reduced set-up costs, maintenance issues, and procedural times.”

The patented ASPIRE MAX Mechanical Thrombectomy System includes an ASPIRE Mechanical Aspirator (drive unit/pump) and over-the-wire thrombectomy catheters. ASPIRE Mechanical Aspirators are available alone and may be connected to any thrombectomy catheter the clinician chooses.

Control Medical Technology designs, develops, and markets innovative thrombus management, biopsy, and aspiration devices, including the patented ASPIRE Mechanical Aspirator™, ASPIRE RX-LP6 Mechanical Thrombectomy System™, and ASPIRE MAX Thrombectomy System™. For more information, call 1-954-9345 or visit www.CONTROLMEDTECH.com.

Control Medical Media contact:
Chris Livingstone
(954) 534-9345
Chris@ASPIRATIONMEDICAL.com
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ASPIRE MECHANICAL ASPIRATOR removes blood clots and improves patient care
July 26, 2013

Park City, Utah--–– Dr. Nick Cavros, interventional cardiologist with Cardiovascular Institute of the South (CIS) at Lafayette General Medical Center in Lafayette, Louisiana, was among the first to use a new hand-held mechanical thrombectomy system to remove blood clots and restore blood flow.

The patented and FDA cleared ASPIRE Mechanical Aspirator and ASPIRE MAX Mechanical Thrombectomy Catheter System was designed, developed, and tested in Utah. The ASPIRE systems allow clinicians to instantly start, stop, increase, decrease, maintain, or pulse aspiration during a variety of procedures.

“Most people know that blood clots are lethal in the heart and brain. But, blood clots can be life-threatening in the legs, lung, and other organs too,” said Dr. Cavros. “Our CIS team has experience treating a wide range of blood clots with numerous tools. We focus on the patient’s needs and tailor the right therapy to improve care—fast.”

Blood clot aspiration is typically performed with basic syringes or electromechanical pumps. Basic syringes require two hands to operate, are volume limited, and do not allow clinicians to control, increase, maintain, or pulse aspiration force. Electromechanical systems can aspirate more volume with increased force, but are expensive, can be difficult to use, require extensive set-up, and do not give the clinician tactile feedback and control during aspiration.

“Speed and accuracy is important to remove blood clots and restore blood flow,” continued Dr. Cavros. “The ASPIRE system improves aspiration speed and performance, and it allows us to use a variety of catheters specific to the patient’s needs.”

“Improving thrombectomy can improve care,” said Shawn Fojtik, CEO of Control Medical Technology. “The ASPIRE Mechanical Aspirator meets this challenge with a simple technology to improve aspiration control and performance. We are pleased that the platform has been used routinely throughout the United States to remove life-threatening blood clots from the ankle to the arm to improve patient care.”

CIS is one of the most respected groups of cardiologists, representing nearly every specialty in heart and circulatory medicine. With a team of nearly 500 dedicated team members, CIS serves communities throughout Louisiana, as well as national and international patients, at its 14 clinics. CIS consistently positions itself at the forefront of technology by providing the most up-to-date technology coupled with compassionate care. This mission has guided the institute for nearly 30 years of service to south Louisiana. For more information about CIS, call 1-800-425-2565 or visit www.cardio.com.

Control Medical Technology designs, develops, and markets innovative blood clot (thrombus) management, biopsy, and aspiration devices, including the patented ASPIRE Mechanical Thrombectomy Aspirator, ASPIRE MAX Mechanical Thrombectomy Catheter Systems, and other devices to improve patient care. For more information about Control Medical, call 1-954-9345 or visit www.aspirationmedical.com.

Cardiovascular Institute of the South Media contact:
Anne Kolwe, Marketing Director
Phone: (985) 872-5980
Fax: (985) 851-0780
anne.kolwe@cardio.com
www.cardio.com

Control Medical Media contact:
Carolina Vance
(954) 457-2450
info@ASPIRATIONMEDICAL.com
www.ASPIRATIONMEDICAL.com
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FDA Clears New Blood Clot Aspiration System
March 1, 2012

Park City, Utah-- Control Medical Technology announced receipt of United States Food and Drug Administration (FDA) clearance to market the ASPIRE MAX Thrombus Aspiration System.

The patented ASPIRE MAX Thrombus Aspiration System bridges the gap between basic syringe-catheter kits and complex electromechanical systems. The core ASPIRE Aspirator is a high-performance aspirator with integrated handles and valves that allows clinicians to instantly create, increase, decrease, slow, stop, or “pulse” aspiration force. MAX Thrombus Aspiration Catheters are proprietary large lumen aspiration catheters available in multiple outer diameters and lengths to improve aspiration speed, force, and control.

Blood clot size, anatomical location, and age can affect procedural success. Aspirating thrombus can reduce pain, promote healing, prevent amputation, prevent further organ damage, and save lives. Medical devices used to remove thrombus range from basic syringe-catheter kits to complex electromechanical catheter systems.

Basic syringe-catheters kits are effective with some thrombus, but lack power, anti-reinjection safety features, and do not give the physician the ability to instantly increase, decrease, pulse, or control aspiration force. Electromechanical systems can be powerful, but lack simplicity, global availability, and may be cost-inefficient.

“We are pleased to receive FDA clearance,” said Shawn Fojtik, CEO of Control Medical. “Clinicians describe the ASPIRE as an ‘Aspiration Gas Pedal’ that allows them to control aspiration like never before. We look forward to seeing it used to improve patient care.”

The FDA clearance allows Control Medical to market the ASPIRE MAX Thrombus Aspiration Catheter System including an ASPIRE Aspirator and a MAX Catheter as a package and/or MAX Aspiration Catheters alone in multiple sizes with an indication to remove soft fresh thrombi, and emboli, from vessels in the peripheral vasculature.

“Blood clots vary from acute, fresh, and soft thrombus to chronic, old, and organized clots,” continued Fojtik. “There is no ‘one size fits all’ technology to remove thrombus. Too often, medical device innovation results in complicated and expensive devices. We want to innovate simple, safe, and high-performance technologies that work better than basic technologies but are easier to use and cost less than complicated alternatives.”

Control Medical Technology www.ASPIRATIONMEDICAL.com. is headquartered in Park City, Utah. The ASPIRE MAX Thrombus Aspiration System, ASPIRE Aspirator, and MAX Aspiration Catheters are made in the United States.

Media contact:
Carmen Aguilera
info@ASPIRATIONMEDICAL.com
(954) 534-9345
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Control Medical Earns New Patent from the U.S. Patent and Trademark Office
August 18, 2011

Park City, Utah-- The U.S. Patent and Trademark Office awarded Control Medical Technology patent #7,976,511 on the ASPIRE Aspiration System. This new patent increases Control Medical’s patent portfolio to (4) four issued patents and (7) seven pending U.S. and global patents.

"We are excited to earn new patent protection for the ASPIRE Aspiration System," said Shawn Fojtik, Control's Chief Executive Officer. "Each time we show the system to clinicians, we learn of new procedures where the ASPIRE Aspiration System can improve patient care. We look forward to filling needs with a safe, efficient, and cost-effective system."

The ASPIRE Aspiration System includes devices under development for thrombus (blood clot) aspiration, tissue resection, biopsy, and general fluid aspiration. The ASPIRE Aspirator, core to the Aspiration System, is FDA cleared to aspirate fluids. Control’s MAX Aspiration Catheters are not FDA cleared or for sale at this time.

Control Medical is developing a family of Aspirator devices for aspiration, thrombus extraction, biopsy, and other applications where fluids are aspirated through small devices to diagnose, treat, or enable other medical devices. Control Medical Technology is headquartered in Park City, Utah USA, www.ASPIRATIONMEDICAL.com.
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Control Medical Earns New Patent from the U.S. Patent and Trademark Office
March 19, 2010

Park City, Utah-- Control Medical Technology announced it received a new patent #7,674,247 from the U.S. Patent and Trademark Office on the Double Barrel Aspirator. The company also confirmed the Double Barrel Aspirator is registered with the European Union's Office for Harmonization in the Internal Market Trade Marks and Design (OHIM). Control now has three issued and numerous other pending U.S. and global patents.

Control's Double Barrel Aspirator's design hinges the front and rear handles directly to the Double Barrel Plunger and Barrels. Squeezing the handles pushes one plunger in to inject while it simultaneously pulls the other plunger out. The Double Barrel may also be configured with automatic one-way valves to supply the injection barrel or drain the aspiration barrel.

"The Double Barrel Aspirator is promising technology to serve a number of clinical needs," said Shawn Fojtik, Control's Chief Executive Officer. "The technology may power internal injection catheters, needles, tubes, or trocars for improved aspiration and/or be configured for surgical lavage, sinus lavage, and other procedures where injection and aspiration are required."

Disposable syringes are used worldwide in millions of procedures per year to assist in blood clot removal; biopsy; drainage of abscesses, cysts, and plural effusions; and other procedures. The Aspirator platform is open ended with universal connectors in a variety of barrel sizes that are compatible with multiple catheters, needles, and related medical devices.

Control Medical is developing a family of Aspirator devices for aspiration, thrombus extraction, biopsy, and other applications where fluids are aspirated through small devices to diagnose, treat, or enable other medical devices. Control Medical Technology is headquartered in Park City, Utah USA, www.aspirationmedical.com, www.maspirator.com and www.maxpirator.com.
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New Cost-Effective Medical Device Improves Fluid Aspiration
August 18, 2009

Park City, Utah-- Control Medical Technology, LLC announced a new cost-effective medical device to improve fluid aspiration from the body.

The Maspirator™ is a catheter accessory and manual surgical instruments that reduces the viscosity of tissue, pathology, and other fluids inside a catheter to improve aspiration.

A disposable Maspirator may be connected to an ASPIRE Aspiration Device or ordinary syringes. Maspirator technology is manually actuated by the physician's hand to facilitate tactile feel and control of the device.

"The Maspirator is a cost-effective hand-actuated device to improve aspiration effectiveness and control," said Shawn Fojtik, Control Medical Technology's Chief Executive Officer. "This technology will allow clinicians to control maceration and aspiration of fluids, tissues, and pathology inside a catheter. This technology is another example of our commitment to improve patient care and aspiration performance for a number of procedures."

Control Medical Technology secured the web site domains and will show the technology to physician advisers in 2009 at the Trans Catheter Therapeutics meeting. Control Medical is headquartered in Park City, Utah USA, www.aspirationmedical.com, www.maspirator.com and www.maxpirator.com.
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Control Medical Closes Series A Financing with Strategic Investors
May 14, 2009

Control Medical Technology, LLC announced the closing of a Series A financing with a team of medical device manufacturers, global distributors, and investors. Spring Bay Ventures, a medical-technology focused investor based in Jacksonville, Florida, led the funding.

“We are excited about the opportunity to invest in Control Medical Technology, led by Shawn Fojtik,” said Daniel Ryan, Vice President of Spring Bay Ventures. “Shawn is a terrific innovator with a proven ability to turn his ideas into businesses that meet clinical needs.” Mr. Ryan will be joining the Board of Directors of Control Medical Technology.

Control Medical’s ASPIRE aspiration platform under development may be used to remove fluids, tissue, thrombus (blood clots), and other pathology for use in cardiovascular, oncology, spine, pain management, wound irrigation/lavage, and general procedures.

According to the company, ASPIRE biopsy systems may be the first cost-effective 100% disposable rotational vacuum-assisted technology for breast biopsy. Rotational vacuum-assisted technologies spin a needle, catheter, or trocar with vacuum aspiration force to ‘cut and core’ tissue for improved biopsy quality and diagnostic confidence.

In addition, the ASPIRE platform can be modified to perform prostate and general biopsy; spinal disc decompression; bone marrow extraction (autologous stem cell harvesting); and other procedures.

“Rotational vacuum-assisted biopsy technologies improve breast biopsy diagnostics, but typically require expensive capital equipment and consumables limiting patient access,” said Shawn Fojtik, CEO of Control Medical. “The ASPIRE system does not require new capital equipment and gives the clinician control/tactile feel for the procedure.”

Control Medical is also planning to expand the ASPIRE platform into thrombus aspiration for heart attack, stroke, and hemodialysis access.

“There are global unmet needs for simplified thrombus aspiration systems,” commented Mr. Fojtik. “ASPIRE rotational and non-rotational thrombus aspiration catheters and systems under development include innovations for use in acute myocardial infarction, ischemic stroke, and hemodialysis grafts.”

Control Medical Technology’s team recently led Pinyon Medical Technology. Within 28-months of funding, Pinyons earned one U.S. patent, added four new patent applications, obtained two FDA 510(k) approvals, won a global 2008 Medical Design Excellence Award (MDEA), and then sold to Covidien.

The ASPIRE Aspirator is FDA 510(k) cleared but not for sale at this time. Roberts Mitani, LLC (www.robertsmitani.com) advised Control Medical in connection with this financing. Control Medical is headquartered in Park City, Utah with global sales offices in Florida www.ASPIRATIONMEDICAL.com.
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New Medical Device Removes Large Blood Clot From Patient’s Heart... more
September 8, 2014


FDA Clears New Mechanical Blood Clot Removal System For Coronary & Peripheral Vasculature... more
September 5, 2014


Mechanical Blood Clot Removal System Helps Clean Up Patient’s Leg ... more


ASPIRE ASPIRATOR removes blood clots and improves patient care
July 29, 2013 Release
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New Blood Clot Removal System Successfully Restores Blood Flow
July 25, 2013
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