Market Set for a Giant Leap

Growth is being driven by both, new cardiac centers primarily in Tier-II and Tier-III cities, and additional cath labs in existing setups in metro and Tier-I cities.

Indian MedTech industry is on the brink of breathtaking innovations with emerging smarter technologies that offer incredible cost savings and tremendous advances in patient diagnosis and treatment. The number of hospitals and nursing homes in the country is continuously increasing, and with it the demand for various medical equipment and devices.

The incidence of coronary artery disease in India is on the rise and it has been the single biggest factor contributing to increase in interventional cardiac procedures. With 32 million Indians having cardiac issues, of whom 15 million are from the urban areas, and 17 million from the rural parts of the country, the Indian cath labs market is expected to grow in coming years. The growth will also be driven by both new cardiac centers, primarily in Tier-II and Tier-III cities, and additional cath labs in existing setups in metro and Tier-I cities.

A number of Tier-II and Tier-III setups are looking for viable and reliable cath lab solutions for their low volume setups. Mobile cath labs are gradually becoming a preferred form of cardiac care as it decreases procedural costs, increasing its feasibility. In addition, there is also an increasing preference for flat-detector labs.

India stands at one-tenth of developed countries in the number of cath labs per coronary heart disease cases. There is a dire need for qualified technicians for interventional cardiology to ensure that the country catches up with rising disease occurrence and realizes the government’s vision Healthcare for All.

Indian Market
In 2016, the Indian cath labs market is estimated at 632 crore, with the imported segment at 295.75 crore and the indigenous and unorganized segment constituting 70 crore. The contribution of this segment is for the performance and value systems, which are more popular in Tier-II and now in Tier-III cities. The government continues to account for the top-of-the line models. The mobile systems are finding preference over the fixed ones in the value segment.

The differentiating factors between various brands are diminishing, with most systems on similar price points offering similar capabilities and features. Gradually, brand loyalty and other factors as prompt servicing, attitude of sales and marketing team, proximity with customers, etc., will be the determining factors for gaining market share. Undoubtedly, digital detector size, the smaller ones optimal for cardiac procedures and the larger ones used to perform run-offs, ablation techniques, or tumor/vein embolizations are major causes of price variation. On a similar note, swing labs, digital cath lab equipment that is suitable for both cardiac work and a variety of vascular and neurological applications, are gaining popularity.

Philips continues to lead the segment, with GE and Siemens offering stiff competition. Toshiba is more successful with the government, whereas Allengers is dominating the indigenous segment at Tier-II (and now Tier-III) cities. Shimadzu and Schiller are also aggressive in this segment.

Technology Update
The industry is witnessing a shift in technologies from the well-established procedures such as transcatheter closure of atrial septal defects (ASDs) and patent foramen ovale, balloon mitral valvuloplasty (BMV), and transcatheter alcohol septal ablation (TASH) for hypertrophic cardiomyopathy to next-generation coronary imaging technology and robotic-assisted percutaneous coronary intervention. With the advancements in the use of intracardiac echocardiography (ICE), 3-D echocardiography (3-DE), and multi-detector computed tomography (MDCT), with fluoroscopic overlay to produce 3-D images of intracardiac structures, operators can better visualize cardiac anatomy and provide real-time information to support a faster, more precise surgical workflow, optimize patient outcomes and minimize risk.

Advancements in angiography systems. Angiographic imaging system vendors have developed several new technologies to address emerging cath lab trends, including the need to reduce radiation dose, improve image quality, and enable advanced procedural image guidance. All three of these have become increasingly important as more complex procedures are attempted in interventional cardiology cath labs and hybrid ORs. These procedures include transcatheter aortic valve replacement (TAVR), MitraClip repairs, left atrial appendage (LAA) occlusions, atrial and ventricular septal defect closures, and new interventions for both electrophysiology (EP) and heart failure.

All major vendors have introduced new systems and technologies in the past few years to reduce dose and enhance visualization in the cath lab. The vendors have tailored their systems into various models for specific specialties and at various price points depending on the degree of functionality. Most vendors also offer software to enhance visualization of stents and other devices.

Newer imaging systems enable advanced 3-D imaging with rotational angiography, which uses a quick spin around the patient to create a computed tomography (CT)-like, 3-D image of the anatomy. This can all be done tableside in the cath lab. Some systems allow these images, or CT or magnetic resonance imaging (MRI) 3-D images, to be overlaid or fused with the live 2-D fluoroscopic images. This fusion technology is used with TAVR planning and navigation software to better guide precise device placement. Software also allows 3-D images to be integrated with EP electromapping systems to guide catheter ablation procedures without the need for live fluoroscopy, helping to reduce dose.

Next-generation coronary imaging technology. Optical coherence tomography is a next-generation coronary imaging platform that helps the physicians to analyze vessel characteristics. This information assists in stent selection using near-infrared light to create images that provide more details than angiograms alone, creating an even more effective cath lab.

Robotic-assisted percutaneous coronary intervention. The cath lab industry has been on a revolutionary edge right from the introduction of robotics in cath labs to successful implementation of robotic-assisted percutaneous coronary intervention procedures in hospitals. Recent reports have claimed the safety and feasibility of these robotic systems in the treatment of complex intervention, augmenting the ability to deliver treatment with robotic precision and significant reduction in radiation exposure. The technology has been used to wire coronaries for percutaneous coronary interventions (PCI) or pressure measurement, balloon/stent advancement or to complete a chronic total occlusion (CTO) intervention once crossed manually with the ability to measure anatomy with sub-millimeter precision and to position stents with 1 mm movements to potentially improve patient outcomes.

Monitoring dose in real time. The concern for modern research resides in real-time X-ray radiation dose monitoring for cath lab staff, where the detector badges relay live dose data to a display monitor in the cath lab. It has visual display, showing colored indications (red, yellow, green) to give each individual user insight about the current dose exposure. The accumulated dose per individual user also is captured and displayed on the touch screen display. The data is stored and can be viewed in a dose dashboard in the system’s dose manager software, which includes total dose history and easily generates reports for staff use and archives.

The intervention of these cutting-edge technologies and growing emphasis to transform the cardiology market with minimum cost inputs and high-quality outcomes is igniting the cath lab market. With an increase in the number of hospitals, there has been a sharp rise in the number of catheterization laboratories being put up. With the pace at which technologies are evolving, the next decade promises an even brighter scope for the cath lab industry to embark on a journey to reach new heights.

Challenges
High-end cath labs are indeed costly and are the main constraints for developing countries including India. In addition to financial constraints, major concerns have been raised over exposure to ionizing radiation. With a multifold increase in interventional cardiology procedures that rely on fluoroscopy, there is an exponential rise in the incidences of damages due to chronic exposure to ionizing radiation. Although the number of percutaneous coronary interventions (PCIs) has stabilized over the past several years, interventional cardiology teams face increasing amounts of scatter radiation exposure because of an increase in the number of complex and radial PCIs performed in the cath lab. Chunks of data show interventional cardiologists having higher rates of left-sided brain tumors, skin cancer, posterior sub capsular lens changes (a precursor to cataracts), thyroid disease, and neuro-degenerative disease.

Several methods reduce interventionalists’ exposure to ionizing radiation. One way is through the use of personal protective equipment (PPE). However, leaded aprons and other PPE exert continuous pressure on the spine, hips, knees, etc. In addition, interventionalists often have to place their bodies in awkward positions to view monitors or maintain positioning behind radio-protective shields, which intensifies the strain that PPE places on the musculoskeletal system. Orthopedic pain has been associated with work absences and some interventionalists have needed spinal surgery.

As more complex cases are being done on interventional X-ray systems, radiation dose for both patients and staff is a major concern and improvement area for vendors. More and more hospitals are now insisting on buying cath labs with grid switch tubes that help in lowering dose for the patients, technologists, and doctors.

The advanced procedures such as transcatheter structural heart procedures for repair of septal defects, left atrial appendage (LAA) occlusion, paravalvular leaks, and transcatheter aortic valve replacement (TAVR) are increasing dose exposure which is raising questions over their feasibility, and stability of these systems.

Although several potential makers have introduced platforms which offer real-time radiation dose-monitoring and dose-lowering technologies, these concerns still pose a challenge to the expanding cath lab industry.

Leveraging Data Analytics
Automation and data analytics allows the industry to transform data into actionable insights that lower costs, reduce waste, optimize efficiency, and boost the overall patient experience. Hospitals are looking to leverage radio-frequency identification (RFID) automation and inventory data to better align cath lab inventory with clinical use and promote cost savings.

Data analytics, which offers end-to-end visibility, is a key to optimizing efficiency for staff and controlling inventory supply management costs in the cath lab. Automated RFID inventory management and analytics allows hospital leaders to better predict, trend and analyze product utilization at every touch point along the enterprise, identifying areas to eliminate waste. The technology helps to ensure hospitals have the correct amount of cath lab inventory on hand and helps to prevent expired, obsolete or recalled products from staying on the shelves or mistakenly reaching patients.

RFID helps accurately document and capture charges at the point of use, including the unique device identifiers, which help track and report implantables for registries and Meaningful Use Stage 3, all while streamlining audit processes. Data analytics also enables supply chain leaders to speak a common language with physicians to drive evidence-based decisions.

The need for reliable data cannot be understated, whether in terms of patient volume potential for a new technology/technique or procedure, or for understanding the clinical, operational, and financial impact of an already-adopted advancement. Knowing the current situation in the cath lab and having the information readily available for determining the future impact of something new can make all the difference between success and failure.

Moving Forward
With coming of newer devices and technology, the market for cath lab is set for a giant leap. With declining coronary procedure volumes and many new interventional technologies, almost half of financial return from cardiac cath labs will come from non-coronary procedures by 2020. These will include trans-catheter valve repairs or replacements (TAVR) and left-atrial appendage (LAA) occlude placements to eliminate the need for warfarin in atrial fibrillation (AF) patients. There are a lot of forthcoming revolutions that will change the way physicians utilize their time in the cath lab. The next generation of advances will improve operator performance, enable more complex procedures, change the reimbursement system, improve patient and operator safety, and expand the use of minimally invasive cardiovascular procedures into new areas that were previously only the domain of surgeons.

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