Friday 21 October 2011, Amsterdam
Emerging Technologies Such as Drug-eluting Balloons and MRI Compatible Pacemakers to have Substantial Impact on the Cardiovascular Devices Market
Drug-eluting Balloons (DEB) are one of the most successful technologies to emerge in the cardiovascular market in recent years. DEBs have introduced a new dimension to the way coronary and peripheral artery diseases are treated, and the greater adoption of this technology is bound to have a substantial impact on the interventional cardiovascular devices market.
It is estimated that that about 1.1 million percutaneous stenting procedures are done across the globe and approximately 25% of these patients suffer from In Stent Restenosis (ISR). The use of DEBs in this population is expected to drive the growth of the DEB market in the coming years.
DEBs are anti-restenotic drug coated PTCA (Percuatneous Transluminal Coronary Angioplasty) balloons which are intended to prevent the renarrowing of the coronary artery after stent placement. They are designed for intraluminal drug application in coronary arteries and peripheral vessels to treat ISR, bifurcations, small vessels, and long lesions. The use of drug-coated balloons appears to hold promise as a viable alternative to stand-alone balloon angioplasty and stent implantation for the treatment of coronary and peripheral arterial disease.
The global market for DEBs was $104.6m in 2010 and is forecast to reach $178m in 2017. Driven by positive results from various previous and ongoing clinical trials the acceptance of DEB as a suitable treatment option is increasing.
The major companies that market DEBs are B Braun (SeQuent Please), Medtronic (IN.PACT, with Invatec’s acquisition) and Eurocor (DIOR).
DEB as a technology is known to be much simpler and less invasive than other treatment options and has the potential to create interest among interventional surgeons to be used in niche populations for treating ISR and bifurcation lesions.
Magnetic Resonance Imaging (MRI) compatible devices are expected to experience a high adoption rate by surgeons and are expected to be the mainstay in cardiac rhythm management (CRM) over the years.
Conventional implantable devices for CRM do not offer compatibility with MRI, which is of importance in diagnosing events like stroke, cancer, problems with the spinal cord and brain and other conditions. There are about four million patients worldwide with pacemakers and over 75% of them require an MRI scan. About 20,000 patients in the US annually forego MRIs as they have a pacemaker implanted. This is an unmet need that many companies are trying to address through developing MRI compatible pacemakers that would allow patients with implanted devices to safely undergo required diagnostic imaging tests.
Medtronic, St. Jude Medical and Boston Scientific are key players who market MRI compatible pacemakers. The Revo MRI Sure Scan from Medtronic is the first MRI compatible pacemaker approved by the US Food and Drug Administration (FDA). St. Jude’s Accent has received the Conformité Européenne (CE) mark for sale in Europe, while Ingenio from Boston Scientific is still in the pipeline.
Application of Femtosecond Laser Therapy in the Treatment of Cataract – A Technology that Enhances Precision and Accuracy in Surgery
The application of femtosecond laser for cataract surgery has enhanced the outcome of the surgery by increasing precision and accuracy in the surgery. Use of this technology is seen to result in improved quality of life for the patient as pre-existing vision disorders such as presbyopia and astigmatism could be corrected with the use of premium Intra Ocular Lense (IOLs) after femtosecond laser therapy. This technology increases the accuracy, safety and reproducibility of corneal and capsular incisions that take out the cataract. With the help of the image guided femtosecond laser, correction of pre-existing and surgically induced astigmatism is possible. The use of femtosecond laser therapy has been approved by the US FDA in 2010.
Experts are of the opinion that the precision of femtosecond lasers in cataract surgery would enhance outcomes in areas of measurement. This would be a very important factor considering the fact that the usage of premium IOLs depends on a well-centered capsulotomy. Consistency of the capsulotomy is a key factor for ensuring optimal premium IOL implantation and for achieving targeted refractive endpoints. Exact placement of the lens is becoming increasingly important in treatment for accommodating lenses that require some optical-mechanical engagement of the ciliary body-capsular bag complex with a consistent movement and noncircular capsulotomies.
The adoption of femtosecond laser therapy in cataract surgery which provides near-perfect capsulotomy that is not possible by human hand is expected to receive a boost as the use of premium IOLs increases and patients become aware of the available technology that would greatly improve their quality of life.
Advances in Remote Patient Monitoring to Reduce Overall Healthcare Costs and Strengthen Management of Patient Data
Application of Remote Patient Monitoring (RPM) is leading to reduction in healthcare delivery costs. Wireless technology is helping doctors with real-time access to a patient’s medical history including treatments, medications, laboratory tests and insurance information. Wireless technology is not only increasing access to doctors but is also playing a role in improving the quality of life of the patients.
RPM would also address the problem of a shortage of doctors and medical personnel to some extent. With the facility of RPM, home based healthcare can be extended, with several patients being monitored remotely rather than having to wait at the physician’s office. According to The
American Academy of Family Physicians (AAFP), there will be a shortage of about 40,000 primary physicians by 2020 in The US. The European Commission also reports physician shortage across healthcare centers in Europe. The implementation of remote patient monitoring would provide a solution to this shortage and also help in restricting healthcare costs.
RPM is known to reduce the number of clinic visits and healthcare expenditure to a considerable extent which is why the government in the US has undertaken initiatives to encourage the use of RPM. In July 2010, the US FDA signed a Memorandum of Understanding (MOU) with the Federal Communications Commission (FCC) to manage regulatory processes for medical devices with wireless technology more efficiently, and to have set processes for safety and efficacy issues.
Advances in Orthobiologics to Increase their Application in Management of Several Orthopedic Indications
Technological advances in the field of orthobiologics are leading to these materials being used in treating many orthopedic indications that otherwise were treated conventionally. The advent of synthetic bone grafts using growth stimulators, Bone Morphogentic Proteins (BMP), Platelet Derived Growth Factors (PDGF) and tissue engineered scaffolds has found application in joint reconstruction, spinal surgeries and in treating sports injuries.
The most significant and striking application of bone graft materials has been in spinal surgery. Degenerative disc disease is treated by removing the damaged disc, introducing bone graft in its place and allowing new bone to act as a bridge between the two vertebras. It is estimated that about 75% of all bone grafts would be used for spinal fusion in The US. The number of spinal fusion procedures using bone grafts is increasing and advances in orthobiologics certainly auger well for the overall growth of the orthobiologics market.
Growth factors are being used for the repair of degenerative joint disease as these growth factors help in tissue repair. The degranulation process initiates cellular proliferation and tissue repair response, resulting in the growth of cartilage and increased joint mobility. Orthobiologics are fast finding a place in the repair of foot and ankle injuries too. It is estimated that more than 100,000 foot and ankle bone grafting procedures are done in the US.
Apart from these indications, orthobiologics finds application in treating sports injuries, orthopedic trauma and in joint reconstruction.
There is an unmet need for soft tissue reinforcement grafts, which if catered to would significantly increase the demand for orthobiolgics. Biomaterials that can effectively promote tissue regeneration for the treatment of soft tissue injuries hold tremendous promise as these soft tissue injuries are difficult to treat. Advances in orthobiologics have made possible the treatment of hard tissue injury. At the same time expansion of the use of these biomaterials for the treatment of soft tissue injuries such as the Achilles tendon, rotator cuff injuries and injuries to ligament and cartilage in the knee would see a tremendous increase in demand for orthibiologics.
