Structural heart diseases are acquired through wear or birth. The most common are issues regarding the valves that separate each chamber of the heart (mitral, aortic, tricuspid, and pulmonic) and stop blood going back to the chamber it comes.
- Leaky heart valve or regurgitation. It is a born-with disease in which the patient has a hole in the valve. For example, Mitral Regurgitation affects the mitral valve, allowing blood to leak backward into the left atrium. It can be solved with a Mitraclip procedure.
- Heart Valve Stenosis. It is a disease compromising one of the valves, which does not open properly because of the thickness, stiffen or fuse of its flaps. A solution for this condition is a valve replacement (Transcatheter Aortic Valve Replacement, TAVR) or repairing the valve (Balloon Valvuloplasty)
In Vitro Diagnostics (IVD)
IVD are medical devices and accessories which are used to perform a test on samples of the human body. These samples are pulled out of the human body and analyzed in vitro. Some of the examples of tissue that this kind of medical device is used could be blood, urine, and fat tissue.
The propose of IVD medical devices is to give information about a physiological or pathological state, a congenital abnormality, or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures.
Atrial Fibrillation is an irregular or abnormal heart rate that can increase your risk of strokes and heart failure.
- Laser catheter ablation is a current method of treatment for atrial fibrillation. The catheter is guided to the heart and destroys areas of heart tissue that are causing rapid and irregular heartbeats.
- Maze procedures. The doctor uses a scalpel to create a pattern of scar tissue that interferes with stray electrical impulses causing atrial fibrillation.
- Atrioventricular node ablation. The procedure involves using a catheter to deliver radiofrequency energy to the pathway (AV node) connecting the upper and lower heart chambers.
Ophthalmology is the branch of medicine that deals with the physiology, anatomy, and diseases of the eye. Ophthalmic devices are primarily used for treating various eye conditions and infections.
Ophthalmic Devices include a wide range of design types and applications: glasses, contact lenses, intraocular lenses, implants, diagnostics, laser, and surgical solutions. Diagnosis, surgery, and vision care are the primary applications.
Deep Brain Stimulation is a technology that acts on brain cells. The technology involves modulation of brain cells activity by delivering electrical or pharmaceutical agents directly to the target area. Neuromodulation medical devices can stimulate a response where there was previously none. There are a significant number of disorders that can be treated with it, like spinal cord injuries and Parkinson’s disease, among others.
Spinal Cord Injuries
Patients with a Spinal Cord Injury (SCI) have a daily challenge living with reduced or without mobility. Advances in technology are empowering those with SCI and enabling them to live fuller and more active lives, as everyday activities become more comfortable and more accessible.
Applying technology to rehabilitation is helping to restore the abilities to use arms and legs immobilized, as well as to control bladder function. Other advances are related to neuroprostheses, which delivers electrical stimulation to the brain areas where the function has been lost. Virtual Reality is being used in robotic exoskeletons and wheelchair driving performance.
Hypertension continues to be a significant contributor to global morbidity and mortality, with an abundance of patience with uncontrolled blood pressure despite the multitude of pharmacological options available. The target now is to use device-based therapies.
- Renal denervation (RDN). It is a minimally invasive procedure to treat resistant hypertension. The procedure uses radiofrequency ablation to burn the nerves in the renal arteries. This process causes a reduction in nerve activity, which decreases blood pressure.
- Baroflex activation therapy (BAT). It is a therapy that uses an implanted device to electrically stimulate baroreceptors in the carotid sinus region, which elicits a reflex response through the sympathetic and vagal nervous systems that reduce blood pressure.
- Carotid body ablation. Carotid bodies are peripheral chemoreceptors that regulate sympathetic tone and respiratory minute ventilation in response to stimuli such as hypoxia or acidosis. The ablation of the carotid body (CB) function has been proposed as a target for circulatory regulation.
- Central iliac arteries anastomosis. It is a therapy that intends to reduce effective arterial volume, systemic vascular resistance (SVR), and cardiac afterload, lowering blood pressure.
Implant and Digital Dentistry
Digital implant surgery or digital navigation implant surgery consists in using a 3D computer simulation to check the conditions of bone and nerve position.
It is possible to put the new dental implant and decrease the pain and the recovery time with a minimal and precise incision. It also reduces the risk of infection. With this technology, you can avoid sensitive zones and any damage to them.
CAD-CAM prosthesis. It is a technology that helps to improve the design of artificial teeth replacing missing teeth or another dental treatment.
It is necessary first to scan the tooth or dental implant in the study model to be worked on, a scan of the antagonist, and the bite. Then, the computer design prosthesis using 3D software (which helps calculate the insertion axes). The last step is the robotic manufacturing of the dental pieces, based on the design information of the prosthesis in a short time.
Endocrinology and Diabetes
Diabetes is a systemic disease that affects the entire vascular system.
Diabetic patients have an increased risk for restenosis, and their clinical follow-up is characterized by a higher incidence of death, myocardial infarction.
This makes diabetes management as a relevant matter to solve. Some of the solutions that the industry is providing are related to drug dispensers and self-monitoring of blood glucose.
Sepsis is a life-threatening organ dysfunction due to a dysregulated host response to infection. It is necessary to get antibiotics. But you may need other treatments depending on the symptoms: ventilator to help you breathe, surgery to remove areas of infection or another treatment in an intensive unit.
AI/Machine Learning SaMD
Medical device manufacturers are using these two technologies to change their products to assist health care providers better and improve patient care. They have the advantage to adapt and optimize medical devices used in real-time to improve health care for patients continuously.
- Artificial Intelligence is the engineering of making intelligent machines, especially intelligent computer programs (McCarthy, 2007). All of these using different techniques based on a statistical analysis of data and machine learning.
- Machine Learning SaMD is a kind of software as a Medical Device since it is an artificial intelligence technique that can be used to design and train software algorithms to learn from and act on databases.
Minimally Invasive Surgery
Laparoscopy Surgery is done through one or more small incisions, using small tubes and tiny cameras and surgical instruments. Laparoscopy Surgery was one of the first types of minimally invasive surgery. Another type of minimally invasive surgery is robotic surgery. It provides a magnified, 3D view of the surgical site, and helps the surgeon operate with precision, flexibility, and control.
Endovascular Aortic Repair Treatment (EVAR)
This type of endovascular surgery is used to treat the pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA). The procedure involves the placement of an expandable stent graft within the aorta to treat aortic disease without operating directly on the aorta. In 2003, EVAR surpassed open aortic surgery as the most common technique for repair of AAA. When it is used to treat a thoracic aortic disease, the procedure is then precisely termed TEVAR for “thoracic endovascular aortic/aneurysm repair”.
Percutaneous Coronary Interventions (PCI)
PCI is a non-surgical procedure to treat Coronary Artery Diseases. Besides, it improves blood flow, decreases angina pectoris, and helps in several heart diseases.
The catheter is inserted into the blood vessels to place a small structure in the heart to open blood vessels where the coronary artery has been narrowed. When the tip is in place, a balloon tip covered with a stent is inflated. The balloon tip compresses the plaque and expands the stent. Once the plaque is compressed, and the stent is in place, the balloon is deflated and withdrawn. The stent stays in the artery, holding it open.
Transcatheter Aortic Valve Repair (TAVR)
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure to replace the aortic valve for patients with severe and symptomatic aortic stenosis (narrowing of the aortic valve opening). TAVR is performed on a beating heart and does not require a large surgical incision or the support of a heart-lung machine.
Neurovascular Mechanical Thrombectomy
Neurovascular Mechanical Thrombectomy is the removal of thrombus that is obstructing blood circulation in the brain, using a Stent.
A catheter is inserted into the leg artery, and the catheter advances to the place where the thrombus is located. There the stent is released and then proceeds to remove the thrombus and unclog the artery.