Within the medical device technology industry, the cardiovascular sector is one of the largest and most stable, due to immediate demand and necessity. As with all areas in the field, engineers continuously strive to design more minimally invasive devices, but with cardiovascular diseases at the top of the list in a growing elderly population, there is an urgent need for continuous advancement. Furthermore, the high-risk procedures involved in cardiovascular repair means there is no room for device imperfection. The need for advancement is particularly strong in the areas of prevention and treatment of congestive heart failure and atrial fibrillation (AF).
Several new devices have emerged in recent months, proving effective and groundbreaking. Devices that are currently seeing the most market growth in the industry include pacemakers, coronary stents, implantable cardiac defibrillators, and angioplasty products. Medical device engineers are continuously challenged to create more biocompatible, minimally invasive, yet sturdy, long-lasting products. Perhaps one of the most exciting technologies to keep an eye out for are biocompatible products and devices such as bioabsorbable stents and devices coated with a bioengineered surface.
When it comes to devices that aid in the treatment of AF and other cardiac rhythm management, there is a need for longer-lasting products. "The current focus of development is on reaching lower defibrillation thresholds, which is likely to lead to conservation of energy and subsequently, enhance generator life," says Frost & Sullivan analysts. "Miniaturization is also being pursued actively, with efforts aimed at reducing the generator size and volume."
Remote Cardiac Monitoring
The cardiovascular device field is also showing itself capable of keeping up with the thriving remote health monitoring market, with a growing popularity of mobile heart monitoring devices. Several notable studies and trials are working to advance the implementation and success rates of these devices. UCSF has developed an online cardiovascular study that uses smartphones to monitor patients’ heart vitals while sending pertinent information to medical professionals who analyze the data, providing instant and often life-saving feedback.
Medicomp Inc. has also recently introduced the SAVI Air, a wireless event monitor, which gives analysis over the entire ECG. This capability makes the SAVI Air a novel device in the industry. "What makes the SAVI Air wireless event monitor truly stand out is our Diogenes algorithm, which resides on our entire line of monitors and is widely regarded as the most advanced artificial intelligence technology in the industry," says Dan Balda, M.D., Medicomp CEO.
Cardionet’s MCOT service is currently one of the most successful, widely used remote cardiac telemetry device, with over 300,000 patients monitored in real time since 2010. Telemetry devices of this kind are quickly surpassing the traditional Holter devices, due to their broader coverage and increased accuracy.
However, since it is a fairly new medical device technology, remote monitoring struggles to gain a wide foothold. “Despite strong technology advances in this area, development of the market continues to be hindered by changes to reimbursement,” says Nicola Goatman, IHS Analyst. “As reimbursement continues to decline, remote cardiac monitoring service providers struggle to stay afloat in an increasingly unpredictable market.”
Bioresorbable Vascular Scaffolding
Stents are one of the most traditional, well-established cardiovascular devices, but recent concerns over restenosis and late stent thrombosis (LST) have created a renewed need for further development. When drug-coated stents came along, there was a temporary solution to the problem; however, the polymer material that typically bonds the drug to the stent often causes the very LST it had originally sought to prevent. Following the trends of the more recent biocompatible materials, “disappearing stents,” or bioresorbable vascular scaffolds (BVS), were created. These types of devices are designed to dissolve in the body over time. The ABSORB BVS is one such absorbable device by Abbott Vascular, which was recently introduced to the European market. Plans to introduce the product in the U.S. are currently set for 2016.
Other products are currently testing biodegradable polymers in the race for FDA approval, including the EVOLVE II Synergy stent by Boston Scientific and the COMPARE II BioMatrix by Biosensors. CorMatrix Cardiovascular has been the most recent recipient of three U.S. patents for replacement heart valves that utilize a completely unique biomaterial called extracellular matrix (ECM). “Extracellular matrix is a naturally occurring substance that helps regulate cells and is present in all humans and animals,” said Robert Matheny, M.D., chief scientific officer for CorMatrix. “After sterilization and testing, CorMatrix ECM is an exceptionally strong, but very pliable and thin sheet that can be sewn onto the heart to facilitate the repair of different heart structures,” said Dr. Matheny.
Endovascular & Transcatheter: Replacement and Repair
Other areas seeing significant headway are devices that enable endovascular aneurysm repair. “The next frontier involves the treatment of aneurysms that are close to the renal arteries,” says Louise Murphy, of Millenium Research Group (MRG). “A new generation of grafts, termed fenestrated or branched grafts have cut-outs for the renals, with renal graft insertions, giving the stent graft arms.” These grafts are highly versatile, such as the Zenith Fenestrated, by Cook Medical, which are customizable for the physician, based on each patient’s anatomical map and need. Medtronic and Endologix are currently seeking to bring their more affordable and universally efficient off-the-shelf fenestrated stent grafts to the U.S. market.
In the quest for the most minimally invasive procedures, the treatment of aortic valve disease is often sought through endovascular methods, such as those used in transcatheter aortic valve replacement (TAVR). However, as with many new medical products, the introduction and approval of novel devices into the U.S. market is a challenging and oftentimes lengthy one. “The success of TAVR is leading the way for increased research and development for treating heart valve disorders percutaenously, with each of the other three valves, pulmonary, tricuspid and mitral, each having been successfully treated endovascularly,” says Murphy.
Transcatheter valves traditionally were constructed of metal or tissue-based materials, but these implants require invasive procedures. For elderly patients, these high-risk procedures are not an option. Implantable transcathater valves currently being developed are aimed at reducing procedural risks. Successful products seeing significant popularity growth include the Sapien valve by Edwards Lifesciences, and the CoreValve by Medtronic.
The most cutting-edge, novel cardiovascular devices worth further noting are still in the pre-marketing and development stages. The industry’s outlook is an exciting one right now, with several projects in the works. Many of these products are on the cusp of a new level of never-before seen advancement, proving that in the world of cardiovascular, the best is yet to come.