Monday, September 29, 2014

Medical Device Sales: “Fascinating, Captain!” Part 6

By Rick Fromme

Photo credit:
The diversity of new, innovative medical innovations never ceases to amaze me. If you can think of a human physiological condition, malady or extenuating circumstance involving health and wellness, chances are there’s a research team or firm somewhere in the world that’s working on it. 

This month’s edition of “Fascinating, Captain!” our ongoing series on new medical technologies, readily evinces this. (For more editions of this series, see our previous blogs, "Fascinating Captain!” Part 5 through Part1.)  From advancements in ultrasound technology, to a newly improved spinal disc implant, to an implantable device to improve memory, to a European-invented monitoring system to prevent driver fatigue, I think you’ll agree that the breadth of medical device inventions are indeed, to quote Star Trek’s Mr. Spock, “Fascinating, Captain!”

Advancement in Ultrasound Allows for Assessment of Soft-Tissue 

Photo credit:
A new method of ultrasound is being developed to examine soft tissue, including tendons and ligaments. Vanderby, MS, PhD, of the University of Wisconsin-Madison (UW-Madison), is commercializing an ultrasound technique that can analyze the condition of soft tissue. The method was created as a result of insight from Hirohito Kobayashi, Vanderby’s former PhD student, who “had an analytical insight into the way waves propagate,” according to Vanderby.

Dr. Vanderby works in orthopedics. He and Kobayahi developed equations that described the physics of sound waves in living tissue. 

Vanderby has since patented the resulting processes through the Wisconsin Alumni Research Foundation, which has licensed the technology to Echometrix. The software can be loaded on to a laptop and employs images from any ultrasound instrument. 

In ligaments and tendons, stiffness changes are dependent on whether tissue is intact, healing, or damaged. Dr. Vanderby says, “We can measure from the ultrasound image how physically compromised it is.” The software was approved by the FDA in 2012 and is currently being used in human studies to monitor treatment of injuries to hand tendons, the Achilles tendon, and the plantar fascia.

However, examining ligaments and tendons are not the only applications of this technology. Vanderby explains that any stressed, soft tissue could exhibit similar physical behavior. The new technology could be used to detect changes ―for example in tumors or in atherosclerosis ― where stiffness would evince degradation of the blood vessels.

Medtronic’s PRESTIGE LP Cervical Disc System Now Available in U.S.

Photo credit:
The FDA has approved Medtronic’s PRESTIGE® LP Cervical Disc System, an implant intended to treat single-level diseased discs, whether from radiculopathy and/or myelopathy.

The PRESTIGE LP Disc is a titanium ceramic composite device with two articulating components (ball on top & trough on the bottom) that are attached to the vertebral bodies. This ball-and-trough design provides for replication of normal motion. The device is available in a variety of sizes to allow surgeons to closely match patients’ anatomy.

This is an upgrade to the PRESTIGE disc Medtronic released in 2007, which featured a ball-and-trough socket that maintains natural bending, rotation, and translation of the two components relative to each other.

This newer, LP version uses different materials and an improved fixation mechanism that utilizes two rails that press into pre-drilled apertures, instead of the commonly used bone screws. Medtronic says its proprietary titanium-ceramic composite has demonstrated slower wear, while producing less visual scatter during MRI scans when compared to stainless steel. The device has been available around the world for a decade now, with the FDA finally issuing approval following a prospective, multicenter, historical-controlled IDE trial in the U.S.

While a fusion with an anterior cervical plate allows most patients to return to normal activities within a very short period of time, the artificial disc may provide an alternative solution for those patients suffering from degenerative disc disease.

 DARPA/UCLA Project to Restore Brain Injury Patients' Memories 


As part of a major federal initiative, UCLA has been awarded $15M to create a wireless, implantable device that could restore memory to millions.
Photo credit:

UCLA has been tapped by the Defense Advanced Research Projects Agency (DARPA) to spearhead an innovative project aimed at developing a wireless, implantable brain device that could help restore lost memory function in individuals who have suffered debilitating brain injuries and other disorders.

According to the Centers for Disease Control and Prevention (CDC), traumatic brain injury (TBI) is a major cause of disability and death in the U.S. and contributes to around 30% of all deaths related to injury. TBI can have effects such as impaired thinking, movement, sensation, emotional functioning and memory.

TBI can be caused by a bump, blow or jolt to the head. Not all blows to the head result in a TBI, yet when they do, normal functioning of the brain can be disrupted. In 2010, about 2.5 million emergency department (ED) visits, hospitalizations, or deaths were associated with TBI.

The four-year effort, to be led by UCLA's Program in Memory Restoration and funded by up to $15 million from DARPA, will involve a team of experts in neurosurgery, engineering, neurobiology, psychology and physics who will collaborate to create, surgically implant and test the new "neuroprosthesis" in patients.

Innovative System Anticipates Driver Fatigue to Prevent Accidents

Photo credit:
Instituto de Biomecánica de Valencia (Biomechanics Institute - IBV) has worked on the development of a system with seamlessly integrated smart textiles that can measure heartbeat and respiratory rate to help prevent driver fatigue and sleepiness at the wheel. This is being researched and developed in the framework of a European project, called Harken.

This non-invasive sensor system measures heartbeat and respiratory rate embedded into the seat cover and the seat belt of the vehicle. Up to now, no system was capable of measuring those vital constants in a car non-invasively.

When people go into a state of fatigue or drowsiness, modifications appear in their breathing and heart rate; the Harken system can monitor those variables and therefore warn the driver before the onset of symptoms of fatigue.

The outcome of this project is a fully functional prototype that monitors the physiology of fatigue-associated symptoms vis-a-vis breathing and heart rate, with the aim of reducing the number of sleep- induced accidents.

The innovative Harken device, developed by companies, universities and technology centers of the consortium, measures both variables on a scenario affected by vibrations and user movements, by means of intelligent materials embedded into the seat cover and the seat belt. The system detects the mechanical effect of the heart beat and the respiratory activity, filtering and cancelling the noise caused by the moving vehicle elements (vibrations and body movements), and by calculating the relevant parameters that will be integrated into future fatigue or somnolence detectors.

The system is based on three main components: the seat sensor, the seat belt sensor and the signal-processing unit (SPU), which processes the sensor data in real time. Because of its integration possibilities, these sensors are invisible to the driver.

In this sixth edition of our ongoing series, “Fascinating Captain!” I shared with you some of the innovative medical devices that have recently received FDA approval or that will one day find their way into the ever-expanding medical device and consumer marketplaces. The diversity of medical device inventions throughout the world helps many of us to" live long and prosper.” If you found this article interesting and useful, please share it with your colleagues and friends. As always, I’m eager to read your comments and questions below.

Rick Fromme combines entrepreneurial enthusiasm with an insider's knowledge of the medical industry to co-found Both his drive and perspective helps provide health care professionals with a superior mechanism with which to communicate, network and market their strengths. Prior to founding, Rick operated a highly successful medical device distributorship. Other milestones in his 12-year career in the medical industry include a key position at a medical device start-up company that was later sold to the Ethicon Endo division of Johnson & Johnson. You may also reach Rick by connecting with him on FacebookTwitterGoogle+LinkedIn and YouTube.