Finding Balance through Innovation

#1 Flexible Intralumenal Robotics:

This novel catheter-based technology allows precise remote manipulations within the intra-luminal space with precision and reproducibility that surpasses human capabilities. This technology is likely to have applications in urology, cardiology, cardiac surgery, and other specialties.

Increasing clinical experience has been acquired for this truly cutting-edge device technology in the past year, particularly in interventional cardiology. It has proven especially useful in electrophysiology applications to assist in catheter positioning during ablation procedures; however, this technology holds great promise for wide-ranging catheter-based technologies such as endovascular grafting procedures.

#1 Flexible Intralumenal Robotics:

A novel catheter-based technology has been developed that allows precise remote manipulations within the intra-luminal space with precision and reproducibility that surpasses human capabilities. This technology is likely to have applications in urology, cardiology, cardiac surgery, and other specialties.

Increasing clinical experience has been acquired for this truly cutting-edge device technology, particularly in intervention cardiology. It has been proven especially useful in electrophysiology applications to assist in catheter positioning during ablation procedures. However, this technology holds great promise for wide-ranging catheter-based technologies such as endovascular grafting procedures. Current device development is focused on improving precision, ergonomics, and reducing occupational radiation exposure. In a recently completed preclinical in vivo study, it was reported that vascular robot technology can provide catheter navigation in a much faster and less traumatic way compared with conventional manual catheterization.

#2 Percutaneous Aortic Heart Valves:

For high-risk patients, a technique has been developed that involves inserting a new expandable wire mesh valve with internal valve leaflets. The valve is inserted through a groin or small chest wall incision and then fed up through a catheter into position with X-ray screening. The balloon is inflated to secure the new valve.

The percutaneous insertion of aortic valve prostheses are quickly becoming a viable treatment option for high-risk cases, while increasing experience and improved instrumentation will lead to its adoption in elective cases as well. Different versions of this technology are now undergoing clinical trials in the U.S., while the total worldwide experience now numbers in the thousands.

#2 Percutaneous Aortic Heart Valves:

For high-risk patients, a technique has been developed that involves inserting a new expandable wire mesh valve with internal valve leaflets. These valves can be inserted through blood vessels in the groin and threaded into the heart or through a small chest wall incision.

The indications, benefits, and pitfalls of this technology are now being explored in numerous international clinical trials. In addition, major valve makers have made multiple strategic acquisitions of new supporting technologies to position their products for this promising market. Development of technologies for percutaneous valve replacement or reconstruction of the mitral and pulmonary valves has progressed as well. The FDA approved the first percutaneous heart valve in early 2010 under the Humanitarian Device Exception program.

#3 RNA-based Therapeutics:

This particular innovation uses RNA antisense technology to treat patients who are unable to reach their targeted cholesterol levels with statins alone or who are statin intolerant. The therapy is intended to reduce the production of ApoB-100, a protein that carries certain forms of cholesterol and triglycerides in the bloodstream.

This remains a compelling and very active area of research and development. Agents are in various stages of clinical trials for a diverse range of conditions, including viral infections, cancer, macular degeneration, and hereditary hypercholesterolemia.

#3 RNA-based Therapeutics:

This particular innovation uses RNA antisense technology to treat patients who are unable to reach their targeted cholesterol levels with statins alone or who are statin intolerant. The therapy is intended to reduce the production of ApoB-100, a protein that carries certain forms of cholesterol and triglycerides in the bloodstream.

Phase III trials are underway to evaluate the efficacy of RNA antisense-based technology on patients with familial hypercholesterolemia. Other clinical trials are also being conducted to examine efficacy in reducing low-density lipoprotein levels in high-risk hypercholesterolemia patients with encouraging early results. Clinical trials are also underway for this technology for a diverse range of conditions including viral infections, cancer, and macular degeneration.

#4 Convergence of Advances in Genome Scanning and Informatics to Support Clinical Applications:

New genetic testing can be used to develop personalized risk assessments and disease management plans for variety of genetically caused diseases.

There has been a very rapid development during the past couple of years, with the number of commercially available genomic tests growing by 25% annually; this has been especially evident in hematology and oncology. Concerns and uncertainty about reliability and interpretation of results remain an issue. Clinicians are trying to corroborate the findings yielded by this technology with clinical events.

#4 Convergence of Advances in Genome Scanning and Informatics to Support Clinical Applications:

Genetic testing that can be used for personalized risk assessment and disease management has undergone very rapid development during the past couple of years particularly in cardiology, with the number of commercially available genomic tests growing by 25% annually. Clinicians are trying to corroborate the findings yielded by this technology with clinical events.

Most of these tests look at a single gene and are used to diagnosis rare genetic disorders; however, whole genome scanning is also being developed in this increasingly competitive field. There is growing interest in the development of tests that look at multiple genes that may increase or decrease an individual's global risk for diseases such as cancer or diabetes.

#5 Oral anticoagulant Drugs for Treating and Preventing Thrombosiss:

Newer anticoagulant treatments are being introduced with the goal of curbing complications such as bleeding and thrombosis.

In the past year, increasing experience has been obtained with new generation oral anti-coagulants (such as anti-Factor X) in various stages of clinical trials. Compared to existing therapies, these agents continue to hold great promise for providing effective anticoagulation with decreased complications and easier monitoring.

#5 Oral anticoagulant Drugs for Treating and Preventing Thrombosiss:

New anticoagulant treatments are being introduced with the goal of curbing complications such as bleeding and thrombosis. Compared to existing therapies, these agents continue to hold great promise for providing effective anticoagulation for patients with atrial fibrillation or who are at risk for deep venous thrombosis. Early results of clinical trials with these new agents suggest that they may be used with decreased complications and easier monitoring compared with existing treatments.

The FDA approved dabigatran in 2010, while a Factor X drug was resubmitted in 2011 for review.

#6 Live Attenuated Influenza Vaccine for Children as Young as Two Years:

Nasal drops containing live attenuated flu can be used as a vaccine in lieu of needles, and provide effective protection from influenza for this high-risk population.

During the past year, studies have demonstrated the increased efficacy of live influenza vaccines, while the nasal route of delivery (bypassing needle administration) is especially valuable in children. This expanded the U.S. patient population by 10 million. However, use of live attenuated virus was not approved for children aged six months to two years.

#6 Live Attenuated Influenza Vaccine for Children as Young as Two Years:

Nasal drops containing live attenuated flu can be used as a vaccine in lieu of needles, and provide effective protection from influenza for this high-risk population. Beginning with the 2008/09 influenza season, annual vaccination for all children aged 6 months to 18 years was recommended.

A live attenuated influenza intranasal vaccine for the novel H1N1 influenza virus was approved by the FDA in 2009.

#7 Image Fusion for Diagnostic and Therapeutic Use:

This technology is used to diagnose medical problems, both anatomic and physiologic in nature, as well as to assist minimally invasive procedures-such as stent placement or tumor ablation.

SPECT/CT imaging in cardiovascular disease is still in development for most applications but holds promise for combined imaging of the myocardium and coronary arteries in ischemic heart disease or as a tool to determine the inflammatory nature of plaque burden in larger vessels. SPECT/CT continues to be useful in oncologic imaging, especially for neuroendocrine tumors or melanoma and can be a useful adjunct in localized inflammatory lesions such as infected orthopedic prostheses.

#7 Image Fusion for Diagnostic and Therapeutic Use:

This technology is used to diagnose medical problems, both anatomic and physiologic in nature, as well as to assist minimally invasive procedures-such as stent placement or tumor ablation.

Current development is focused on determining which applications of the technology produce the most benefit. SPECT/CT imaging in cardiovascular disease holds promise for combined imaging of the myocardium and coronary arteries in ischemic heart disease and as a tool to determine the inflammatory nature of plaque burden. SPECT/CT can be a useful adjunct in oncologic imaging, especially for neuroendocrine tumors or melanoma and may provide more detail regarding the extent of disease in these cases. SPECT/CT can also be a useful adjunct in determining the extent of disease in cases of infected device implants, such as infected joint prostheses.

#8 Implanted Device Allowing Neural Control of Objects by the Severely Disabled:

Novel communication interfaces are being developed for severely motor-impaired individuals to provide the ability to control devices and to potentially restore limb movements. This interface system is designed for individuals with spinal cord injuries, stroke, ALS, and other central nervous system injuries.

Devices remain in early clinical trials for the treatment of patients following spinal cord injury or those suffering from degenerative neurological diseases such as ALS (Lou Gehrig Disease).

#8 Implanted Device Allowing Neural Control of Objects by the Severely Disabled:

Novel communication interfaces are being developed for severely motor-impaired individuals to provide the ability to control devices and to potentially restore limb movements. This interface system is designed for individuals paralyzed by spinal cord injuries, stroke, amyotrophic lateral sclerosis, and other advanced central nervous system diseases. Current technology utilizes multiple electrodes incorporated into a tiny device that is surgically implanted into areas of the brain that control movement. The neuronal signature from these areas then undergoes decoding to direct the movement of a computer cursor and other assistive devices.

Pilot clinical trials are currently being conducted and a limited number of patients have demonstrated that they can indeed exert control of external devices with their thoughts and can direct communication technology-such as email-by visualizing the movement of their hand.

#9 Engineered Cartilage Products for Joint Repair:

Natural biomaterials have been developed to replace joint cartilage tissue damaged from injury or arthritis. The materials are surgically implanted into the joint with the intent to restore the damaged cartilage and avoid joint replacement surgery.

Second-generation products from several companies are undergoing FDA clinical trials with launches in the U.S. not likely until 2009.

#9 Engineered Cartilage Products for Joint Repair:

Biomaterials have been developed to replace joint cartilage damaged from injury or arthritis. The materials are surgically implanted into the joint with the intent to restore the damaged cartilage and avoid joint replacement surgery. Advancements are being made for technologies that employ autologous and synthetic materials used for cartilage substitutes in joint reconstruction. All replacement technologies must reproduce the delicate interplay between cellular, structural support and biomolecular elements that constitute normal cartilage.

New materials currently under development have been shown to be stronger and to possess the ability to better withstand pressure than materials used in previous generations of this technology.

#10 Dual Energy Source Computed Tomography (CT) Imaging:

The CT device features two X-ray sources and two radiation detectors, which allow for imaging of patients more quickly and with less radiation. The speed at which the dual-source scanner operates allows physicians to image patients with high or irregular heart rates, which used to be a significant limitation of this technology.

Increased speed in image acquisition provided by a dual energy source has greatly expanded the application of CT imaging in cardiac disease. The associated multi-row detection technology has improved device portability that allows real-time imaging to be performed to assist a vast number of applications in orthopedics, neurointervention, and in the ICU setting. The technology continues to improve, offering better resolution and lower radiation dose.

#10 Dual Energy Source Computed Tomography (CT) Imaging:

The CT device features two x-ray sources and two radiation detectors, which allow for imaging of patients more quickly and with less radiation. The speed at which the dual-source scanner operates allows physicians to image patients with high or irregular heart rates, which used to be a significant limitation of this technology.

Increased speed in image acquisition provided by a dual energy source has greatly expanded the application of CT imaging in cardiac disease. Clinicians are now applying this technology to vascular imaging, evaluation of renal disease, and CT colonography. Imaging protocols for dual energy source CT studies can now be performed with equivalent or even lower radiation exposure than before.