Control Medical Technology Announces New Device Removes Large Blood Clots in 1st Deep Vein Thrombosis (DVT) Patient Use
January 22, 2021
Control Medical Technology today announced the FDA cleared Control 11F Mechanical Thrombectomy system was used to remove large blood clots from patients with deep vein thrombosis (DVT). The system is Utah born, designed, engineered, patent prosecuted, and manufactured.
“The Control 11 French Mechanical Thrombectomy System can remove large clots,” said Shawn Fojtik, President of Control Medical Technology in Park City, Utah. “Patients, clinicians, and payors need more tools to remove diverse thrombus without excessive expense and complex capital equipment. A disposable $2,000 – $15,000+ device per-patient technology is not the only way to remove blood clots, especially if it sucks too much blood.”
“Control removed large blood clots in our first uses,” said Kishor Vora, M.D., FACC, FSCAI, CCDS, Medical Director at the Owensboro Heart & Vascular Clinic in Owensboro, Kentucky, USA. “Large venous blood clots in the legs is a serious condition. Patients may present with pain, swelling, and other symptoms. Left untreated, deep vein thrombosis (DVT) can lead to life-threatening pulmonary embolism. If clots are not removed from large veins like Common Femoral or Iliac veins in time, it can result in lifelong disabling symptoms like swelling in legs, pain, discoloration and non-healing ulcers.”
Blood-clot and embolic removal, or thrombectomy and embolectomy, is performed throughout the body. Coronary thrombectomy is performed in acute myocardial infarction (AMI), neurovascular thrombectomy in acute ischemic stroke, and peripheral thrombectomy is performed with peripheral arterial disease (PAD), chronic total occlusion (CTO), and deep vein thrombosis (DVT).
“Reducing blood loss is important when removing large clot & emboli,” continued Mr. Fojtik. “Large catheters can remove blood too fast when using electric pumps. Our new FDA cleared system is designed to improve control with a wide range of catheters. We look forward to seeing improved clot targeting, capture, maceration, and removal improve patient care.”
“This is the kind of ground-breaking innovation that will improve the practice of removing large blood clots from patients and save lives,” said Kelvyn Cullimore, president and CEO of BioUtah. “We’re proud that this technology is the product of our home-grown medical device company, Control Medical Technology.”
During thrombectomy & embolectomy procedures, clinicians typically track a catheter to the thrombus/emboli and then use a basic syringe or high-performance aspirator/electric pump to pull the clot/emboli out. Basic syringes lack speed, force, volume, and control. Electric pumps improve force but are complex and reported to suck too much blood with 7+ French (~2.25mm+) outer diameter catheters.
Control Medical’s product platform includes the Control 5 -11 French (~1.5mm – 3.5mm OD) Mechanical Thrombectomy System with over-the-wire (OTW) catheters indicated for use in the peripheral vasculature and the Control RX-LP Mechanical Thrombectomy System with rapid-exchange (RX) catheters indicated for use in peripheral and coronary vasculature.
Control Medical Technology’s platform is distributed by TZ Medical www.TZMedical.com in the USA and protected by issued and pending patents www.AspirationMedical.com. Control Medical Technology Media contact: Carmen Aguilara (954) 534-9345 Carmen@bacinc.info.
Kishor Vora, MD’s contact: https://owensboromedical.com/heart-and-vascular-clinic/provider/kishor-vora-md-facc-fscai-ccds/.
Two Image Collage
Three Images with Catheter
