Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common cardiovascular disorder that affects up to 2 million patients in the U.S. each year. VTE is a significant risk in surgical patient populations where preoperative, operative, and postoperative immobilization may lead to blood stasis. VTE, when poorly treated, may lead to the development of post-thrombotic syndrome (PTS), with symptoms including chronic leg pain, swelling, and ulcers. As a consequence of PTS, many individuals struggle with a reduced quality of life.
Current treatment options for VTE include anticoagulation, catheter-direct thrombolysis (CDT) and pharmacomechanical thrombectomy. However, the efficacy of these methods is disputed. One deficiency of these methods is the use of thrombolytic agents, which may present a risk of internal bleeding, including the potential for an intracranial bleeding event. In particular, such agents are effective because they cause blood thinning and prevent coagulation. However, their use can cause bleeding complications. The use of methods involving thrombolytic agents may also be ineffective to treat against blood clots in larger veins, such as veins located in a patient's leg. Many thrombolytic agents are also costly, and logistically complicated to use.
As an alternative, mechanical compression devices that compress or squeeze portions of a patient's body to force blood flow have been used. But such devices include their own drawbacks. Oftentimes, these kinds of devices are bulky and may impose a considerable burden on hospital staff. Patients are also less inclined to ambulate while using these devices because they typically are burdensome to remove and reapply. Many patients also dislike using mechanical compression systems because such devices are typically uncomfortable. In addition, these kinds of compression devices also may not be effective at treating thrombosis in larger veins.
Accordingly, there is a need for a device that is designed to effectively treat thrombosis in large veins without using thrombolytic agents.