The ECMO market includes disposable products and capital equipment. ECMO products have been in the market for a long time but have only recently started gaining traction. ECMO has experienced a reinvigoration due to positive reports and the stagnation of heart-lung machines in the market. The market is expected to grow as more surgeons view the technique as a better alternative to heart-lung machines.
Anastomosis assist devices (AADs) are used for joining two blood vessels, usually to restore continuity after resection, or to bypass an unresectable disease process. Coronary artery bypass graft (CABG) involves the construction of an alternative path to bypass a narrowed or occluded diseased coronary artery and restore blood flow from the aorta to an area beyond the occlusion. This is accomplished by using harvested veins or arteries as bypass grafts. This harvested vessel is usually the saphenous vein in the leg, the radial artery in the arm or the mammary artery from the chest wall. One end of the harvested vessel is then generally attached to the aorta (proximal anastomosis) and the opposite end is attached to the target coronary vessel on the heart (distal anastomosis). If the mammary artery is used as the bypass graft, it is dissected from the chest wall, leaving the blood inflow end in place, while the opposite dissected end is attached to the target vessel. This provides uninterrupted blood flow and eliminates the need for proximal anastomosis to the aorta. Regardless of the type of vessel used, once in place, these grafts provide sufficient blood flow to bypass the narrowed or occluded portion of the coronary artery.
Annuloplasty is used for restoring an optimal orifice area and shape, providing support and preventing further annular dilatation. Through disease or age, the tissue that supports the heart valves opening, the annulus, can weaken and lose its shape. To repair this condition, a device called an annuloplasty ring or band is sewn around the base of the heart valve to reshape it and give it support. An annuloplasty band or ring is made of durable plastic, metal or fabric and may be flexible or rigid. These rings and bands are designed to hold the natural shape, motion and flexibility of the annulus. An annuloplasty repair procedure usually involves open heart surgery requiring a median sternotomy, but may also be performed minimally invasively via keyhole surgical techniques or percutaneously.
The development and expansion of computerized diagnostic techniques has exerted a downward pressure on procedure numbers, resulting in procedural declines in recent years. Conventional angiographies have started to be replaced by alternative imaging procedures. Growth is expected to gradually increase as the population continues to age.
The vast majority of IVUS catheters are used immediately before, during or after an angioplasty procedure. Intravascular ultrasound (IVUS) catheters are used in conjunction with minimally invasive cardiovascular procedures. Procedures utilizing IVUS catheters must be performed in catheterization laboratories or cath labs that have an IVUS console. These consoles are typically integrated into the cath lab infrastructure and are not portable. The introduction of IVUS consoles to an increasingly large percentage of cath labs in Japan, as well as the introduction of reimbursement programs for IVUS devices, allowed the number of IVUS catheters used to grow rapidly since 2002.
Optical coherence tomography (OCT) is an imaging modality that can create extremely high resolution three-dimensional images of biological tissues and has proven to be very effective for interventional purposes. While OCT has been used for a number of years in other medical fields, such as in ophthalmology, it has only recently been applied to cardiology. In 2017, only a few OCT systems were approved by the FDA for use in cardiology. However, OCT systems were being used for producing high resolution images of arteries in a clinical setting since 2006 in Japan and Europe.
Interventional guidewires are often the first type of device to cross an arterial lesion. For this reason, the choice of guidewire is extremely important in order for a procedure to be successful. Interventional guidewires used for coronary applications can be classified into two general types: conventional and specialty guidewires. While conventional guidewires are used for the most common types of procedures, specialty guidewires are used in cases where the lumen is occluded and a conventional guidewire is unlikely to be successful.
Introducer sheaths facilitate the insertion of devices such as guidewires and catheters for use in interventional procedures. They are tube-shaped and are generally inserted by nurses. Introducer sheaths can also simplify the application of patches and closure devices at the end of procedures to allow hemostasis to occur. Introducer sheaths are sold in a wide range of sizes to fit patient requirements. They need to have kick resistance and an elongated shape that protects vessels from injuries. In addition, introducer sheaths need to have a transparent structure to allow visualization. They are made with lubricated material to minimize the force and pressure during application. These characteristics make patient management much easier for nurses, and the introduction of devices smoother for doctors.
Fractional flow reserve (FFR) is a guidewire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR guidewires are inserted through a diagnostic catheter during a coronary angiogram. While FFR was still used in only a small percentage of angiography procedures, it is useful in assessing whether or not to perform angioplasty or stenting on borderline blockages. FFR provides data that is complementary to information from standard diagnostic guidewires and imaging systems.
Interventional catheters are used by physicians in procedures for the placement of devices such as stents and balloons. There is a large variety of catheters, and their use depends on the size, shape and curvature of the lesion. Cardiologists tend to choose catheters based on their guidewire selection. Interventional catheters must be rigid without being stiff, because the device must adapt itself to the curvature of certain arteries. In addition, catheters must promptly react to a physicians movements, sometimes following zigzag patterns, without risking puncturing the lumen.
Vascular closure devices (VCDs) are used in both the peripheral and coronary markets for minimally invasive cardiovascular therapies, which has created a large market for post-procedural VCDs. The introduction of a catheter into the arterial system, to place a stent for example, is much less traumatic for the patient than a comparable surgical intervention, with only a hole created in the artery (generally the femoral) for access. This access hole will bleed profusely if unmanaged, and therefore some form of vascular closure is required.
The primary uses of balloon-inflation devices are to inflate dilation balloons for stent placement as well as to inject contrast agents for use in diagnostic procedures. Balloon-inflation devices usually consist of a syringe, and sometimes a pressure gauge and a tube to connect the inflation device to the balloon catheter. Balloon-inflation devices are commonly designed to be inflated and deflated with one hand, allowing them to be operated very easily by just one person. Sometimes balloon-inflation devices can be used with self-expanding stents to confirm that they are seated properly and in no danger of moving. In general, balloon-inflation devices (also known as indeflators) consist of a syringe with a manometer or pressure reading instrument and a mechanism that controls the emptying and filling of the syringe. It is possible for dilation balloons to be inflated manually through the use of a simple syringe instead of a balloon-inflation device. However, when dilation balloons are inflated manually, it is not possible to monitor and control the pressure inside of the balloon. Proper monitoring of the pressure inside the balloon is important. If the balloon pressure is too low, the stent may not be completely deployed. If the balloon pressure is too high, there is a risk that the balloon will rupture.
The first devices used in the field of interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA) balloon catheters. If it was not because of subsequent restenosis occurrences, they would still be the only device necessary for atherosclerosis treatment. Restenosis was the major problem plaguing interventional cardiology before stents were developed.
The full report suite on the Japanese market for interventional cardiology includes analysis on the coronary stent, coronary balloon catheter, balloon-inflation device, interventional coronary catheter, interventional coronary guidewire, introducer sheath, coronary vascular closure device, diagnostic coronary catheter and guidewire, fractional flow reserve (FFR) guidewire, intravascular ultrasound (IVUS) catheter, and optical coherence tomography (OCT) catheter markets.
The Chinese market for vascular access devices and accessories includes implantable ports, port needles, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), peripheral intravenous catheters (PIVCs), and dialysis catheters.
The South Korean market for vascular access devices and accessories includes implantable ports, port needles, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), peripheral intravenous catheters (PIVCs), and dialysis catheters.