Vascular closure is a procedure performed for the closure of the puncture created in the arterial wall after the performance of the catheterization procedure by using the active or passive approximators which are designed to provide quick and reliable haemostasis of access site. Manual Compression is considered as the ‘golden standard’ for the haemostasis of the access site. However, limitations such as vascular access site complications and increased blood loss are the main causes of morbidity post catheterization procedures. Currently around 3.5 million cardiac catheterization procedures are performed in Europe and around 4 million procedures in U.S. that are increasing the use of vascular closure devices.
Vascular closure devices (VCD) offers advantages, such as, improved patient comfort, reduced post procedural care and short haemostasis and ambulation time. The physical closure of access site by use of nitinol clips, sutures, collagen and polymer plugs is done by the active approximators, whereas, closure of access site without direct contact of the arterial wall either by using compression devices or by the haemostatic pads/patches is done by passive approximation. Active approximators market is the fastest growing segment due to high efficiency rate and many companies are focusing on this segment to launch new products. For Instance, XPro suture mediated device by Medeon Biodesign, Inc, is one of the upcoming products in the active approximator segment, which is under trial for the closure of 8F-21F femoral access site and has completed its first in man studies in November, 2015.
The use of the vascular closure devices is seen in both the diagnostic and therapeutic interventional procedures. Diagnostic intervention through vascular closure devices is seen for internal organ imaging or diagnosis of the diseases that assess the presence and severity of coronary artery diseases, heart valve problems, heart muscle dysfunction, and congenital heart diseases. Therapeutic intervention is the latest and least invasive technique available for the treatment of conditions such as, stenting or percutaneous coronary intervention in order to minimize risk to the patient and improve health outcomes.
Vascular closure procedures are carried out for the femoral access sites and radial access sites. Femoral access is an age old technique and remains the gold standard for percutaneous coronary procedures because of better feasibility and short learning time along with increased manipulation and excellent visualization. But the complications like increased bleeding risk, obesity of patients and requirement of long term bed rest has given rise to radial access procedures. Radial access controls haemostasis, increases patient comfort, and safety after radial artery closure, which mostly utilizes passive approximators making it more cost effective method.
Due to increase in cardiovascular diseases worldwide, there is an increase in the use of minimal invasive surgery in turn reducing the volume of open heart surgeries performed. This is raising the market for the vascular closure devices aiding the closure of access site post catheterization procedure. Companies, which do not have products in this market, are acquiring start-up companies, small players, existing businesses or funding research. For instance, Cardinal Health acquired Johnson & Johnson’s Cordis business, global leader in cardiology and endovascular devices for $1,944 billion and also Access Closure, a leading manufacturer and distributor of extra vascular devices in U.S.
The most awaited product in the market is MANTA by Essential Medical, Inc an active approximators, which is intended for the use of femoral arteriotomy closure post percutaneous cardiovascular procedures and is awaiting CE Mark and other regulatory approvals. CLET ACD, an arterial closure device by Vasorum Ltd is also a femoral artery site closure device of 6F or 7F procedural sheath and currently the product is under clinical trials to study the safety and efficacy.
The major players operating in the Vascular closure devices market are Abbott Laboratories (U.S.), Advanced Vascular Dynamics (U.S.), B Braun Melsungen AG (Germany), Biotronik International (Germany), C R Bard (U.S.), Cardinal Health (U.S.), Cardiva Medical (U.S.), Morris Innovative (U.S.), Scion Biomedical (U.S.), St Jude Medical (U.S.), Terumo (Japan) and Vascular Solutions (U.S.).
Some of the emerging and start ups are: Merit medicals (U.S.), TZ Medical (U.S.), Z Medicals (U.S.), Hemoband Corporation (U.S.), Hemcon Medical Technologies (U.S.), Benrikal Services (Canada), W.L. Gore and Associates (U.S.), Arstasis, CradioDex (Israel), Beijing PuYi Medical Technology Co., Ltd (China), Endocor GmbH (Germany), Vivasure Medical (Ireland), CP Medicals (U.S.), Creganna Medical (Ireland), Inseal Medical (Israel), Marine Polymer Technology (U.S.), Baxter (U.S.), Medeon Biodesign Inc (China), Straub Medical (U.S.).