Industry Trends There is a risk that the placement or introduction of a device during an interventional coronary procedure can dislodge thrombi or emboli, which could create health risks for the patient that the interventional procedure is intended to prevent. In response to these concerns, many different approaches were taken to deal with this problem,
The transcatheter embolization market is segmented into four types of devices: particle embolics, coil embolics, liquid embolics and vascular plugs. Detachable balloons are also used for embolization procedures, but are not covered in this report because they are rarely used.
The market for surgical grafts in the peripheral vasculature includes the following segments: lower-limb vessel bypass (above-the-knee and below-the-knee indications), extra-anatomical grafts and aortic aneurysm repair (abdominal and thoracic).
The total U.S. market for stent grafts includes three segments: the abdominal aortic aneurysm (AAA) stent graft segment, the fenestrated stent graft segment and the thoracic aortic aneurysm (TAA) stent graft segment.
Thrombosis is defined as the formation of a blood clot inside a blood vessel, which obstructs the flow of blood. Thrombus can become life threatening if it dislodges from the vessel wall and enters the lungs or other vital organ. A fragment of thrombus traveling through the vascular system is called an embolus.
Stents are commonly used as complementary devices during conventional percutaneous transluminal angioplasty (PTA) balloon catheterization in peripheral vascular procedures. The placement of a stent mitigates some complications, such as negative remodeling and elastic recoil effects.
Percutaneous transluminal angioplasty (PTA) balloon catheters can be used in two ways for the treatment of peripheral vascular lesions. One way is to expand the lumen of an obstructed blood vessel; this method is informally referred to as plain-old balloon angioplasty (POBA). During POBA, the balloon catheter is inserted into the narrowed vascular region and expanded with water pressure to press the fatty deposits against the vessel walls. The second use for PTA balloon catheters is for expanding stents to treat vascular blockages.
Intravascular ultrasound (IVUS) can be used as an alternative or adjunctive imaging technique in peripheral procedures. IVUS provides the physician a cross-sectional image of the vessel. An IVUS system consists of two components: the disposable IVUS catheter and the IVUS console.
Introducer sheaths are used for facilitating the insertion of devices into vasculature. These devices include guidewires and catheters that are used during peripheral interventional procedures. In addition, these devices also simplify the application of patches and closure devices to allow hemostasis to occur.
Inferior vena cava filters (IVCFs) prevent pulmonary embolism by intercepting a thrombus before it can enter the circulatory system of the lungs. In general, IVCFs are composed of a nest or lattice of wire collapsed around a catheter that is used to guide the filter. The filter is then expanded or deployed at the desired location, usually just below the junction of the inferior vena cava and the lowest renal vein.
Guidewires are used extensively both in diagnostic and interventional peripheral vascular procedures to deliver treatment options. The guidewire market can best be segmented into standard (non-hydrophilic) or hydrophilic guidewires. Standard guidewires are the predominant type because they can handle more pressure than their hydrophilic counterparts.
Carotid stenting can be accompanied with plaque dislodgment and plaque emboli. Thus, the initial popularity of carotid stents was tainted as these artifacts caused an unacceptably high incidence rate of strokes. Since then, the industry has responded by manufacturing embolic protection devices (EPDs). These devices are used to capture dislodged vascular debris.
Drug-coated balloons have emerged as a promising technology for treating peripheral arterial disease (PAD). These devices are similar to traditional balloon dilation catheters, but feature a drug coating designed to combat restenosis. As of January 2018, DCBs are approved in the United States for use in treating lesions of the superficial femoral artery (SFA) and in AV access procedures. However, several companies are in the process of obtaining approval for BTK use of DCBs.
The catheter market comprises two segments: diagnostic and interventional catheters. Diagnostic catheters are used in combination with X-ray imaging to visualize the main arteries. The screening requires the insertion of contrast agent into the patients veins in order to evaluate and monitor the flow of blood. This technique is referred to as angiography or arteriography. With the aid of guidewires and catheters, the contrast agent labels the patients vasculature
Carotid endarterectomy is a surgical procedure performed to clean plaque off the carotid artery walls, thus reducing the risk of stroke. A vascular surgeon may recommend a carotid endarterectomy if a patient exhibits a moderate (50-70%) or severe (80% or greater) blockage of a carotid artery.
Chronic total occlusions (CTOs) are complete blockages of arteries. In the case of a hard plaque, over 50% of the occlusion could consist of calcified tissue. Soft plaques typically consist of cholesterol, macrophages and other cells. The most common method to cross a CTO is to attempt to pass a guidewire through. In other cases, a specialty hydrophilic guidewire may be used.