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Implantables: Market Challenged by Safety Concerns and Restricted Innovation

Thu, 12/19/2013 - 4:28pm
Melissa Barnes, Associate Editor, MDT

Implantable medical devices (IMDs) make up one of the most competitive and challenging markets in the industry, with issues of security and biocompatibility challenging the marketability of emerging products. The most established area for IMDs remains in the realm of cardiology, with the world market estimated at approximately $6.6 billion last year alone, according to IHS. Some of the more recent applications of implantable technologies include: orthopedics, drug delivery systems, and breast implants with integrated RFID sensors.

In the ever growing battle of healthcare costs, the industry is seeking new options to avoid device malfunctions and infections, and enhance overall safety, security, and biocompatibility. This means suppliers are more pressured than ever to create quality products that meet the extensively rigorous safety concerns implantable devices face.

Current trends in the ICD market show the possibility of combatting present challenges through the reduction of device size, an improvement in battery power, and material composition advancements.Implantable Cardiac Defibrillator Trends
Implantable cardiac defibrillator (ICD) devices make up the largest portion of cardiac related IMDs. Major players in the sector include: Medtronic, St Jude, Boston Scientific, Biotronik, and Sorin Group.

Current trends in the ICD market show the possibility of combatting present challenges through the reduction of device size, an improvement in battery power, and material composition advancements. MRI-safe ICDs are also striving for improvement; however, the stringent U.S. approval barriers makes for a slow, challenging atmosphere for diverse innovation.

An exciting new device known as a sub-cutaneous ICD from Cameron Health has been the first FDA cleared device of its kind, but due to the rigidity of the wire material involved, there is considerably less mobility and comfort for the patient.

“Longer term, the main trend will focus on methods of ‘leadless defibrillation,’ a trend also being investigated in the pacemaker market,” says Stephen Holloway of IHS.

Trials for various methods are currently underway, with promise shown using an ultrasound transmitter. Part of the device consists of an external component that straps onto the chest, sending signals to a receiving electrode, which converts the ultrasound to an electrical impulse.

“Other methods also being investigated include wireless RF stimulation and the use of magnetic field waves for energy transfer,” concludes Holloway.

Left Atrial Appendage Implantables
Atrial fibrillation patients are often treated with oral anticoagulants, which present unwanted results; however, left atrial fibrillation (LAA) closure offers an alternative treatment option to traditional pharmaceuticals.

“LAA closure devices represent a strong market opportunity for medical device companies,” says Sean Messenger, Millennium Research Group.

Epicardial LAA closure devices make minimally invasive procedures possible, with products such as the Lariat by SentreHeart. Endocardial LAA closure devices also offer minimally invasive transcatheter techniques, such as Boston Scientific’s Watchman, St. Jude’s Amplatzer, and Coherex Medical’s Wavecrest. Due to their position inside the heart, more detailed safety data is available for endocardial LAA closures, as they have been required to pass more extensive trials. Consequently, epicardial devices have received swifter approval, though their safety has not been as clinically established.

“As a result, physicians prefer endocardial LAA closure to epicardial LAA closure, as they are more familiar with the technology, safety, and effectiveness,” says Messenger.

Watchman has a great, proven track record in Europe, as it expects to gain U.S. approval in 2014. While other LAA devices are awaiting FDA approval, the potential market is expected to reach over $500 million within the next five years.

Solving Material Safety Concerns
One of the most pressing challenges facing the advancement of IMDs is that of safety and security. Aside from issues concerned with the general biocompatibility of certain materials used in implantable products, another major concern relates to infection management.

“Surgical site infections are a significant concern for surgeons. Approximately 600,000 interbody fusion surgeries are performed each year, and of those, up to 12% (or 71,000) will result in infection, costing hospitals an upwards of almost $7 billion dollars each year,” says Bryan J. McEntire, Chief Technology Officer of Amedica.

Anterior Lumbar Interbody Fusion Device: Anterior Lumbar Interbody Fusion Device, constructed of Amedica’s proprietary Si3N4 biomaterialThe risks involved in the use of IMDs is costly and dangerous, with the possibility of bacterial infections, which in turn can lead to improper internal fusions, implant loosening, complete device failure, and even death. Devices composed of compatible, safe material is one of the greatest means of reducing these risks. To address this, Amedica has developed interbody fusion devices made of Silicon Nitride (Si3N4), a proprietary biomaterial that has been shown to promote bone on-growth. More importantly, the material significantly minimizes a patient’s exposure to infection. This is due to the fact that silicon nitride exhibits less vulnerabilities to bacterial colonization in comparison to other traditional materials.

Another aspect proving the viability of Si3N4 is its strength. The biomaterial is the most fracture resistant ceramic commercially available. Si3N4 has also demonstrated osteointegrative characteristics, giving it greater clinical efficacy. The material is radiolucent, producing no MRI distortion or scattering under CT scans. This allows for optimum view for successful intraoperative placement and postoperative fusion assessment.

“The technology is on track to become the new standard of care for patients suffering from back pain and [for those] who require spinal fusion,” says McEntire.

Currently, Amedica is the only company with FDA clearance for the production of Si3N4 implants, with plans of integrating the proprietary material into other devices, such as hip and knee replacements and suture anchors. In particular, the Anterior Lumbar Interbody Fusion Device has received significant improvements through the use of Si3N4.

Conclusion
Aside from the latest concerns over device security, IMDs must overcome the primary risks related to cost, infection, power, and biocompatibility. The demand for implantable medicine is certainly growing, but true innovation remains stagnant, as designers seek to balance quality with safety, while striving to ensure cost efficiency. Upon analyzing current trends and demands, the real key behind overcoming these challenges appears to be in the exploration of entirely novel materials, components, and overall approaches.

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