Life saving devices as defibrillators need to be accessible in public places and health centers. But in India, where public expenditure on health is hardly 1 percent of GDP, this remains a far cry.
It is a well-known fact that survival rates for sudden cardiac arrest are directly related to how soon victims are defibrillated. For every minute of delay, the chance of survival declines by 7 to 10 percent. But making defibrillators accessible is yet to become a priority of the ministry of health and family welfare.
Indian Market Dynamics
The Indian market for defibrillators in 2015 -16 was valued at 7500 units, at 99.85 crore. The year saw an increase across all segments, albeit the maximum growth continues to be exhibited by biphasic ones. Monophasic defibrillators are still in demand in smaller cities. The spiraling growth anticipated in the AED segment, will only happen once the government takes a firm decision to make this life-saving device available in all public places, as is happening in the western world.
The prices remained stagnant over 2015-16, unlike in 2014-15 and 2013-14, when they fell appreciably. The discerning buyer is no longer buying a defibrillator by itself; he is opting for one built into the patient monitoring system. The tenders from the government too showed preference for these.
2015-16 saw orders from the government of Rajasthan, Chattisgarh and West Bengal, PGI-Chandigarh, and Tamil Nadu Medical Services Corporation Ltd. (TNMSC). Private procurement included purchases by Apollo, AIIMS, Safdarjung Hospital, Fortis and Max Group.
Schiller and Philips continue to dominate this segment, with a combined market share in the vicinity of 65 percent. BPL, Mindray, and Nihon Kohden are aggressive in this segment. Zoll, Stryker – earlier Physio Control, GE, Cardiac Science (marketed by AMDL), Nasan, and Metrax are other players.
There have been several recent advancements in defibrillator technology to extend battery life improvements in patient monitoring to avoid needless shocks introduction of quadripolar lead devices to improve device programming and to improve therapy effectiveness and development of magnetic resonance imaging (MRI)-safe ICDs.
Several newer ICDs offer pacing functions, and many vendors offer wireless remote monitoring/interrogation of the device data with bedside units so patients do not need to come in for regular office visits.
Traditionally, patients with ICDs were unable to undergo MR exams, and underwent CT, cardiac catheterization, EKG, and X-ray exams instead. According to data from the University of California, Los Angeles, out of the more than 200,000 patients who have an ICD implanted per year, about 75 percent of them will have a medical situation in their lifetime that may benefit from MR.
Therefore, those patients whose physicians did not wish to entertain the presumed risks of MR with a defibrillator did not have the opportunity of having this superior diagnostic information that in turn could lead to a change in therapy and management.
But MR-compatible ICDs made out of non-ferrous materials have recently come to the market. In September 2015, Medtronic received FDA approval for its Evera MRI SureScan ICD System. In December 2015, Biotronik's Iperia ICD system won approval to be used during MR exams. Many studies have investigated the safety of using these devices during MR exams, but no one had investigated the value that MR brings to patients with ICDs.
Biederman and fellow researchers at AGH decided to pioneer research in this area. They evaluated 157 patients who were placed in one of the three implantable cardiac device case groups. There were 114 patients put into the neurological group, 36 in the cardiovascular group, and seven in the musculoskeletal group. In 88 percent of the neurology cases, MR provided value for the final diagnoses, and in 18 percent of the cases MR exam altered the diagnoses entirely. For the cardiac and musculoskeletal cases, the extra value percentage was even higher at 92 and 100 percent, respectively.
"There was a marked incremental value to perform the MR," says Biederman, "We knew that just because we could do the MR, didn't mean it was the right thing to do. In this case, however, we redirected appropriate care in a high-risk population comprising patients with neurosurgical, orthopedic, and cardiac pathologies." In late March, Biederman was referred to a patient at AGH who was believed to have had cardiac sarcoidosis for 15 years. One of the cardiologists at the hospital decided to have the patient, who had an ICD, undergo an MR exam, so they imaged his heart and found that he did not have the condition.
"In most cases, that information couldn't be obtained with cardiac catheterization, echo, or nuclear, so the MR added real value. Additionally, the patient did not have to have an open-heart-procedure or a biopsy of the heart muscle and [have the patient face] all of the attendant risks," says Biederman.
Even after 15 years of continuous research and studies, the S-ICD technology is still evolving and the EMBLEM S-ICD represents one of its most recent advances. However, future research and design improvements are still required to address various aspects. For example, a pediatric model of the S-ICD to be used in small children (e.g., <8 years, <30 kg) may be an alternative option in the future.
At least theoretically, subcutaneous defibrillation would require lower energies in these subjects due to their small cardiac mass and transthoracic impedance, and thus, a smaller pediatric model of the S-ICD with lower energy might be feasible. Ongoing improvements in detection algorithms, as with the recent algorithm to avoid TWOS, should further improve S-ICD performance and reduce inappropriate therapies. The possibility of simultaneously analyzing three, rather than one, available sensing vectors to define the rhythm status might be an advantageous feature to be considered and developed in the future.
Finally, the integration of the S-ICD system with leadless pacing, if proved feasible, could play an important role in defibrillation technology, enabling the expansion of the less-invasive S-ICD therapy to a larger cohort of ICD population.
Indian Market Dynamics is based on market research conducted by Medical Buyer in November 2016.