Medical Devices (Part 6)

Medical Devices

Sidne Voice Activation System 2003         

As the first FDA-approved Bluetooth-ready medical device, Sidne represents where the future of Bluetooth is headed in the device industry. The system, which stands for Stryker integrated device network, uses voice recognition to give surgeons control over endoscopy equipment in the operating room without touching a button. Bluetooth technology eliminates tangled cable wires from the control unit to devices on the operating table, and a wireless headshot gives surgeons the freedom to move, as well as answer and dial calls through the hospital. The device is also modular, allowing hospitals to customize the control package based on their needs.

LifePort Organ Transporter 2003

          The method of storing and transporting organs has traditionally involved placing an organ in a cooler filled with ice until the LifePort Organ Transporter came into the picture. The product uses mobile machine perfusion to improve transplant outcomes, allowing the use of more organs and lowering the number of organs discarded. The process involves pumping a cold solution through the organ to reduce tissue damage even while the organ is in transport. The LifePort started as a transporter for kidneys and has been so successful that the product is branching out into use for the heart, pancreas, liver, lung, and intestines.

Pinnacle TPN Management System 2007

In an improvement on patient safety, the Pinnacle system provides a safe and easy way to check, compound, and deliver total parenteral nutrition (TPN) to patients. The device controls intravenous formulations using amino acids, dextrose, electrolytes, and lipids for patients who rely on tube feeding or can't tolerate oral intake of food. The Pinnacle system streamlines the TPN process by combining automated compounding technology with a safety verification system and special software. The system can accurately measure and combine up to nine nutritional compounds and prepares one liter of TPN solution in less than one minute. Its safety-check software and bar coding ensure that solution is going to the correct patient.

Impella 2.5 Circulatory Support System 2008

The Impella 2.5 is a minimally invasive, percutaneous cardiac assist device that allows the heart muscle to rest and recover. Impella is designed to actively unload the left ventricle, reduce heart muscle workload and oxygen consumption, and increase cardiac output and coronary and end-organ perfusion. Impella received FDA 510(k) clearance in June 2008 and has been used to treat heart attack patients, patients undergoing high-risk angioplasty, peripartum cardiomyopathy, and viral myocarditis. It is ¹∕100 the size of the heart. The device is approved in more than 40 countries, has been used to treat more than 1700 patients worldwide, and has been the subject of more than 50 peer-reviewed publications. The device was the recipient of a 2007 Medical Design Excellence Award.

        Many key technologies got their start before MD&DI's inception and before current regulations. Here are a few that have made a significant contribution to the way medicine is practiced.

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Medical Devices (Part 5)

CyberKnife Robotic Radiosurgery System (1999)

The CyberKnife is a miniature linear accelerator mounted to a robotic arm. It noninvasively delivers concentrated beams of radiation to a targeted tumor from multiple positions and angles. The tumor receives a cumulative dose of radiation high enough to control or kill the tumor cells while minimizing radiation exposure to surrounding healthy tissue. It delivers to almost all parts of the body, particularly for surgically complex tumors. In 1999, the device was approved for treatment of tumors in the head and base of skull. In 2001, FDA cleared enhancements to the CyberKnife System for tumors anywhere in the body.

da Vinci Surgical System (1999)

          The da Vinci surgical system has made it possible to treat a broader range of conditions with a minimally invasive approach. The system's microchip technology and 3-D optics enable surgeons to perform complex procedures by making tiny incisions. The da Vinci offers users greater precision, an increased range of motion, improved dexterity, and enhanced visibility. Because of the device, patients may experience less pain, less scarring, reduced risk of infection, and a faster recovery time. The surgical system has been used to treat heart conditions, prostate cancer, endometrial cancer, morbid obesity, and mitral valve regurgitation.

PillCam (2001)

Is your digestive tract ready for its close-up? The PillCam is a capsule that houses a miniature video camera, lights, a transmitter, and batteries. Once a patient swallows the pill and it passes through the digestive tract, it takes photos of the small intestine and sends them to a small recorder affixed to the patient's belt. This technology has helped patients avoid invasive and painful endoscopic diagnostic procedures just by swallowing a pill. It also allows the entire small bowel to be viewed (endoscopes allowed physicians to see only the upper part of the small bowel).

OraQuick Advance Rapid HIV-1/2 Antibody Test (2002)

Major progress has been made since the first AIDS-related diagnostic test was commercialized in 1988. In 2002, the OraQuick Advance Rapid HIV-1/2 Antibody Test became the first rapid HIV test to earn FDA approval. In clinical studies conducted by the manufacturer, OraSure Technologies Inc., the test correctly identified 99.6% of people who were infected with HIV-1 and 100% of people who were not infected with it. The test provides results for patients in about 20 minutes. This is key because with previous tests, which took several days to process, a significant number of patients never returned to the clinic to learn whether or not they were infected. The test can be stored at room temperature, requires no specialized equipment, and can be used in both laboratory and nontraditional clinical settings.

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Medical Devices (Part 4)

Medical Devices

Digital Hearing Aid (1987) 

 

A digital hearing aid isn't automatically superior to analog devices. But starting with the creation of the Nicolet Phoenix the first digital hearing aid in 1987, the devices have become increasingly sophisticated. Much of this owes to digital signal processing technology, which has allowed manufacturers to enhance features and provide users with more comfort and higher-quality hearing. For example, digital hearing aids can drastically reduce feedback while the listener is wearing the device and enhance speech based on temporal or spectral content. The Lyric is the only extended wear hearing device on the market it can be worn continuously for up to 120 days.

Ventricular Assist Device (1992)

          A ventricular assist device (VAD) is a mechanical pump that helps a weak heart pump blood through the body. It is often called a “bridge to transplant” because it can help patients survive until they get a new heart. The BVS 5000, a biventricular assist system manufactured by Abiomed, was the first VAD to earn FDA approval. It has supported thousands of patients since entering the market. Most recently, VADs have evolved to provide long-term support to patients with congestive heart failure.

Medical Lasers (1995)

 Even now, many industry observers say that the surface has only been scratched with medical lasers and their potential. Medical lasers (light amplification by stimulated emission of radiation) use focused light sources to treat or remove tissue, and they are used for a variety of vision, dental, cosmetic, and general surgery procedures. One benefit for surgical procedures is less bleeding; heat from lasers cauterizes blood vessels, which leaves medical personnel with less blood to deal with compared with scalpels. Perhaps the most popular application is LASIK, a type of refractive laser eye surgery to correct myopia, hyperopia, and astigmatism. LASIK surgery has transformed outcomes for patients suffering from these conditions. FDA approved the first excimer laser in 1995.

LightCycler Real-Time PCR (1998)

Molecular diagnostics have paved the way toward individualized medicine. The technology enables point-of-care diagnoses for infectious diseases, meaning infected patients can be identified quickly, enabling immediate treatment and protection for those at risk. One of the best-known devices is the LightCycler Real-Time polymerase chain reaction (PCR) System from Roche Diagnostics. Using PCR, scientists can take a specimen containing a minute amount of genetic material, repeatedly copy a selected region from it, and within hours, generate a sample sufficient to perform a variety of tests. PCR is versatile. Many types of samples (e.g., blood, skin cells, saliva, hair) can be analyzed for nucleic acids. Any sample used for PCR must contain the DNA strand encompassing the region to be amplified.

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Medical Devices (Part 3)

Medical Devices

Angioplasty Balloon Catheter (1980)

In the 1970s, German cardiologist Andreas Gruentzig pioneered coronary angioplasty with the development of the double-lumen dilation catheter that used an inflatable balloon. The angioplasty balloon catheter, used for percutaneous coronary intervention, has both saved and improved the lives of patients. Before it hit the market in 1980, vessel bypass surgery was the most viable way to repair blocked vessels but carried more risks, pain, and cost. In addition to relieving chest pain and helping to prevent heart attacks, the device's significant potential has pulled dozens of medical device companies into the catheter space.

Personal Glucose Meter (1980)

The first portable glucose meter was approved in 1969, but improvements to the technology cannot be emphasized enough. One of the most significant steps in the treatment of diabetes was moving the glucose testing from the hospital to the home. The first personal glucose meter was developed by Miles Laboratories Inc. (later purchased by Bayer). Since the early 1980s, these home-use devices have experienced steady improvements. For example, portable glucose meters with memory have become critical to diabetes care, because they enable diabetics to keep a record and observe trends and patterns. Event markers, digital user interfaces, and no-coding technology have also advanced the treatment standard. The modern meter, such as the True2go glucose meter shown here, can weigh less than an ounce.

Pulse Oximeter (1981)

 The first pulse oximeter was introduced in the United States in 1981. Rather than drawing blood, the device provided a noninvasive way to measure a patient's oxygen saturation level via wavelength measurements. In the 1980s, manufacturers of pulse oximeters introduced much smaller technology that was less expensive and easier to use. The Nellcor Pulse Oximeter (pictured) has evolved from its beginnings 25 years ago into a range of different products, from handheld devices that conduct spot check measurements to compact monitors that use nonadhesive specialty sensors for patients with fragile skin.

Laryngeal Mask Airway (1981)

In 1981, anesthesiologist Archie Brain invented the Laryngeal Mask Airway (LMA), a device that establishes an unobstructed airway in unconscious patients or patients under anesthesia. Brain was looking for a device that could replace endotracheal intubation, a procedure that can cause trauma or unwanted reflux responses in patients. Since Brain's LMA was first used in a hospital in 1988, it has become a staple in operating rooms and ambulances. Many versions of the device exist today including the AuraOnce Disposable Laryngeal Mask (pictured above), which comes in a variety of sizes to fit a range of patients. LMAs have been used in millions of procedures. 

Automated External Defibrillator (1985)     

The automated external defibrillator (AED) has been instrumental in saving lives since it was first developed in 1985. Studies have shown that early defibrillation with an AED can dramatically increase survival rates up to 70%. The device, which uses electricity to stop cardiac arrhythmia and help the heart reestablish a solid rhythm, has become so valuable that CPR training courses often include a segment on their use. These days, AEDs are ubiquitous: commercial aircrafts as well as police, fire, and EMT vehicles usually carry them. FDA approved the first home-use AED in 2004.

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