Control Medical Technology announced the FDA cleared Control 11F Mechanical Thrombectomy system was used to remove large blood clots from patients with deep vein thrombosis (DVT).
Kishor Vora, M.D., FACC, FSCAI, CCDS, Medical Director at the Owensboro Heart & Vascular Clinic in Owensboro, Kentucky, USA, said: “Control removed large blood clots in our first uses. 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, discolouration 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 a peripheral arterial disease (PAD), chronic total occlusion (CTO), and deep vein thrombosis (DVT).
Shawn Fojtik, President of Control Medical Technology in Park City, Utah, said: “The Control 11 French Mechanical Thrombectomy System can remove large clots. 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.”
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.
Fojtik continued: “Reducing blood loss is important when removing large clot & emboli. Large catheters can remove blood too fast when using electric pumps. Our new FDA cleared system is designed, to improved control with a wide range of catheters. We look forward, to seeing improved clot targeting, capture, maceration, and removal improve patient care.”
Control Medical’s product platform includes the Control 5 -11 French 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 the peripheral and coronary vasculature.