Advanced Technologies and Upcoming Product Launches will Boost the Market of Cardiac Assist Devices
Cardiac assist devices (CAD) are mechanical circulatory support devices used to treat end-stage heart failure, refractory angina pectoris, post-cardiopulmonary bypass shock, myocardial infarction, myocarditis, etc. Heart failure is a chronic disease that occurs when degeneration of the heart muscle, causes the heart to become too weak to pump blood at a level sufficient to meet the body’s demands. Heart failure is commonly seen among aged population as they are more prone to the diseases mentioned above and as per projections of WHO, the population of those above 60 years is expected to reach 22% of the overall population by 2050 and by 2020 the number of aged (i.e. 60 and above) would surpass that of the population of 5 years or less. It is also estimated that about 40% of all deaths in the age group of 60 and above will be due to diseases associated with cardiovascular conditions.
Ventricular assist device (VAD) are mechanical pumps designed to support one or two ventricles of the failing heart and depending on supported cardiac chamber the devices are classified as left (LVAD) to augment left ventricle, right (RVAD) for right ventricular support, or both heart ventricles is replaced by Bi-Ventricular Assist devices (BiVAD). The indication for VAD use is an acute cardiogenic shock (post cardiac surgery, myocarditis and massive myocardial infarction) and chronic heart failure. The Total artificial heart is a mechanical assist device for persons with biventricular heart failure and heart transplant candidate. Intra-aortic balloon pump (IABP) or counterpulsation circulatory assist device helps the heart to pump more blood by reducing the workload on the heart and improves the function of the left ventricle as this is the chamber that pumps blood into the aorta. IABP is used in conditions of acute mitral valve regurgitation or severe heart failure, left ventricular failure, unstable angina, etc. It is also used during preoperative, intraoperative, or postoperative cardiac surgeries.
According to IQ4I Analysis, CAD market is expected to reach $4,255.5 million by 2024 and grows at a double digit CAGR. Increasing incidence of heart failure, increase in the prevalence of cardiovascular disorders due to rise in aging population, shortage of heart donors, the rise in the number of clinical studies performed, and technological advancements are some of the drivers of the market. Increasing funding for CAD research, a vast number of pipeline products and growing healthcare budgetary allocation are some of the opportunities that are propelling the growth of the market.
The advanced technologies in Cardiac assist devices are miniaturization of implantable cardiac assist devices, advancement in blood flow technology in case of Ventricular assist devices and Total artificial heart (TAH), minimally invasive technologies or percutaneous approach and incorporation of wireless technology in VAD. VAD and TAH are getting miniaturized so that the devices are suitable for wide range of patient’s group. For instance, the HeartWare Left Ventricular Assist System (LVAS) from Medtronic is a third-generation continuous flow blood pump for the treatment of advanced heart failure. It features a miniaturized centrifugal device, which is small enough to be implanted above the diaphragm in all patients. Likewise, TAH is miniaturized from 70 cc to 50 cc to treat pediatric patients and is approved with CE mark.
The advancement in blood flow technology is the use of Full MagLev Flow technology which is a rotor advancement developed by Medtronic. This technology allows the device’s rotor to be suspended by magnetic forces rather than mechanical bearings and does not cause any damage to blood cells. The development of percutaneous devices or minimally invasive devices over intracorporeal has proven to be more successful as percutaneous implantation is performed without the need for surgery and thereby replacing lengthy hospital stay, the insertion of percutaneous devices generally is technically less difficult. Two percutaneous devices are currently available for short-term mechanical circulatory supports (MCS) which are minimally invasive in nature are the TandemHeart and Abiomed Impella. Similarly, these advantages have made the development of minimally invasive IABP and VAD.
Wireless technology is developed to power VADs which reduces the chances of infections as the cables are not having an entrance point into the body. For instance, ReliantHeart, Inc., and Dualis MedTech GmbH, a provider of wireless energy and charging technology, entered into a partnership to implement a wireless, Transcutaneous Energy Transfer system (TET) exclusively for the HeartAssist5 Ventricular Assist Device and the device has CE approval. Dualis plans to integrate its wireless energy transfer technology MedBase with the HeartAssist5 VAD.
Various cardiac assist devices are in different stages of development and are going through clinical trials in order to provide vigorous clinical data on the safety and efficacy. CorWave, a France based company is developing an LVAD offering considerable advantages when compared to the currently available devices. The VAD available at present uses high speed rotating pump with the continuous flow without pulsation and puts stress on red blood cells. Due to its small size and low power consumption, the device can be fully implanted with the use of wireless energy transfer technology. The upcoming product launch in blood flow technology is the development of centrifugal TAH from Bivacor Company who have approached Japanese researchers for refining the magnetic levitation system used in their TAH and currently in preclinical trials.
Cardiobridge GmbH based in Germany has developed a percutaneous intra aortic circulatory support device for treating acute heart failure and renal impairment. The product is in clinical studies. Likewise, Procyrion’s aortix is a catheter-based small and continuous heart pump for heart failure patients, designed to help assist the heart muscle and boost localized blood flow, instead of operating in heart, it is perched in the aorta. Procyrion’s aortix device is not yet commercially available and requires regulatory approval from FDA.
Scandinavian Real Heart AB, a Sweden based medical device company is developing a total artificial heart with advanced functions and with an outer shell made of titanium as it is not rejected by the body. In May 2017, the company successfully completed phase I pre-clinical animal operations and planning to initiate clinical trials on humans by 2020. The company is also developing heart pump control software that will alter the power and speed of pump depending on the blood pressure of the patient. Likewise, the company Carmat expects surgeons to implant its Carmat heart in about 20 patients by the end of 2017 and hopes that its artificial heart will be certified as a permanent replacement device for Europeans in 2018.
For research, government funding is an important criterion and apart from government funding many private companies and global leaders are contributing the funds for research and development of cardiac assist devices. For instance, in Feb 2017 Duke University school of medicine is currently developing centrifugal-flow left ventricular assist device, the research is funded by Medtronic, plc. (Heartware International, Inc.). BiVACOR Inc., a medical device company working on developing an artificial heart with magnetic levitation (MAGLEV) technology received $250,000 fund from Australian Advance Queensland – Ignite idea fund, to develop a reliable heart pump and wearable controller. Hence funding for research and development will create opportunities to innovate new technologies in cardiac assist device market and advanced technologies and upcoming product launches would further boost the this market
The major players operating in Cardiac Assist Device market include Abbott Laboratories (U.S.), Medtronic (Ireland), Syncardia Systems Inc (U.S.), Teleflex Incorporated (U.S.), Zeon Corporation (Japan), Gettinge Group (Sweden), Berlin Heart GmbH (Germany), ReliantHeart, Inc. (U.S.), Fresenius Medical Care AG & Co. KGaA Care (Germany) and Abiomed, Inc. (U.S.). Some of the other emerging companies operating in Cardiac Assist Device global market include Procyrion (U.S.), Calon Cardio-Technology Ltd (U.K.), CardioBridge GmbH (Germany), Cleveland Heart, Inc. (U.S.), CorWave (France), BiVACOR, Inc. (U.S.), Carmat SA (France), Scandinavian Real Heart (Sweden), Senko Medical Instrument Mfg. CO., LTD (Japan), etc.