Dialysis catheters are used for facilitating dialysis for patients whose kidneys are unable to properly filter water and waste. Most patients treated with dialysis have been diagnosed with end-stage renal disease (ESRD); however, patients suffering from acute kidney failure can also receive dialysis. Glomerular filtration rate (GFR) is a test used to assess kidney function. In turn, patients with chronically low GFRs are diagnosed with chronic kidney disease (CKD). When the GFR drops below the threshold, which is when kidney activity is less than 10% of normal levels, patients are considered to have progressed to Stage 5 CKD or ESRD. Patients with ESRD require a kidney transplant or dialysis. However, many ESRD patients are not suitable candidates for kidney transplants.
The implantable port market comprises conventional and power-injectable implantable ports. Power-injectable implantable ports are capable of withstanding higher pressures than conventional implantable ports in order to facilitate the injection of contrast dye for computed tomography (CT) scan procedures. If a patient has a conventional implantable port and requires a medical scan, the port must be removed and replaced with a power-injectable port.
Peripherally inserted central catheters (PICCs) are introduced through the basilic, cephalic or median cubital veins in the arm, and the tip of the catheter is then directed to the superior vena cava (SVC). PICCs have a wide range of applications and are commonly used for delivering chemotherapy and antibiotics, and for drawing blood. Generally, the devices are used for one week to three months but can range in use from a few days to over a year. This flexibility sets PICCs apart from other vascular access catheters and contributes to the increased use of PICCs in general. The most frequent indwelling time for a PICC is three weeks. Although the number of PICC procedures is relatively small compared with those involving central venous catheters (CVCs), PICCs are taking market share away from other catheter types. This is due to the fact that PICCs are associated with a lower infection rate in comparison to CVCs.
Peripheral intravenous catheters (PIVCs), also known as short peripheral IV catheters, are the most commonly used type of vascular access catheters. Almost 90% of patients admitted to hospitals receive a vascular access device, the vast majority of which are PIVCs. These devices are intended for short-term use, usually no longer than three days, and are inserted into the median cubital vein or the forearm extending for only a few inches. Owing to their peripheral placement, these catheters cannot be used for infusing toxic, irritating or vesicant drugs, including most of those used for chemotherapy. The flow rates of PIVCs are lower than central line catheters, such as central venous catheters (CVCs), making them best suited for blood sampling and infusing fluids and medicine.
The European market for port needles include conventional and safety port needles. Safety port needles include power-injectable and non-power-injectable port needles that feature a needlestick prevention mechanism. The value of the port needle market has appreciated in recent years. The implementation of legislation designed to prevent needlestick injuries in hospitals has led to increasing sales of safety port needles and a spike in the overall port needle market from 2012.
Syringes and needles were the first devices used for vascular access, and they are still widely used in Europe. Syringes are used for a variety of applications, including percutaneous injections, injection into catheters, preparation and transport of drugs, blood draws and non-medical applications. Needles connect to syringes and are used for gaining vascular access. They can be sold in combination with syringes or separately. With the aid of needleless connectors such as Luer locks, syringes can be used without needles.
Atherectomy is a procedure used for removing plaque deposits from arteries. They have traditionally been more effective in peripheral than coronary applications. The success of atherectomies has been driven by the limited performance of existing treatments. Often a blockage is alleviated above the knee, only to have the blood flow deteriorate due to further bottlenecks below the knee. Failure to resolve these vascular limitations can result in critical limb ischemia, ulceration, limb pain or eventual amputation, if left untreated.
Lumen stenosis can occur due to the accumulation of thrombosis or plaque particles in a similar manner to peripheral arterial disease. The accumulation of these plaque particles has also been shown to cause calcification. Lumen stenosis is a considerable problem for both arteriovenous (AV) access surgical grafts and native fistulae because they have poor vessel patency. Due to their tendency to acquire blockages, AV access surgical grafts will require revascularization twice a year, and native fistulae will need to be cleared at least once a year.
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. However, if these guidewire-based methods are not sufficient due to poor visualization and calcified heterogeneous lesions, specialized devices must come into play to enable the subsequent deployment of a stent, PTA balloon or even most atherectomy devices.
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. The patient is usually awake during the procedure, which facilitates the screening process by providing instant feedback to the radiologist. This reduces the chance of complications. With the aid of angiograms, the radiologist is able to identify vascular lumen restrictions and calcifications. Although angiographies are not able to detect atherosclerosis, the procedure can identify the consequences of arterial lesions and reliably pinpoint when a patient requires further intervention.
Carotid stenting can be accompanied with plaque dislodgment and plaque emboli. Thus, the initial popularity of carotid stents were 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.
There are many different EPD platforms available for use in the peripheral vascular market, including filters, arterial occlusion balloons and devices that redirect blood flow.
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.
Pulmonary embolism is a condition that affects over one million individuals each year in Europe and leads to mortality in almost a third of those afflicted. This condition is caused by the accumulation of dislodged bodies in the lungs. These usually originate from blood clots or thrombi from a deep vein in the leg.
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.
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. However, post-surgery complications such as restenosis occur in up to a half of patients who have undergone PTA.
Restenosis is a re-narrowing of the treated blood vessel and leads to decreased blood flow. It is commonly attributed to intimal hyperplasia at the site of the stenting procedure. For this reason, technological innovations, such as covered stents, which physically block cellular intrusion from neointimal hyperplasia (NIHA), have already become commercialized.
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. Because of this property, standard guidewires can handle heavy-duty manipulations and maneuvers. Standard guidewires are produced in a variety of configurations based on shape and size. These variants range in price depending on characteristics such as size and flexibility.