Medical Technology News in 2018: 510(k) Reform and New Cardiovascular Devices

While the healthcare industry enjoyed significant advances in oncology drug development and cancer care in 2018, it also saw major improvements in medical technology.

FDA Modernizes 510(k) Program

In 2017, the FDA cleared 3,173 medical devices through the 510(k) pathway, which is the most commonly used and oldest regulatory pathway for low- to moderate-risk devices. To improve the safety and efficacy of these increasingly complex technologies, the FDA took steps this year to reform and modernize the 510(k) pathway. One of the FDA’s major concerns is the incidence of sponsors comparing their devices to those that are more than 10 years old to demonstrate safety and effectiveness.  According to a recent FDA statement, this scenario means that some devices may not be continually improving.

MedTech globe image, Medical Device, FDA cleared medical devices through the 510(k) pathwayAmong the FDA’s new initiatives, subject first to public feedback, is a potential plan to list on its website cleared devices that demonstrated substantial equivalence to older predicate devices. Their goal is to encourage developers to use more modern predicates; accelerate innovation that brings safer, more effective products to market; and ultimately improve patient care and outcomes. In early 2019, the FDA intends to release new guidance establishing an alternative 510(k) pathway that makes it easier for manufacturers of common device types to support new products using more modern criteria. They outlined their vision in their Medical Device Safety Action Plan.

The iPhone is one device that may enter this alternative pathway. Last June, Apple released their ResearchKit 2.0 update, enabling an iPhone to serve as a digital medical assistant. The update enables researchers to build and maintain apps that track health data and makes it easier for these apps to collect data from speech, hearing tests, and vision tests. ResearchKit could also make it easier for patients to report health events during clinical trials.

If you’d like to learn more about the potential and considerations relevant to digital health devices such as iPhones in clinical trials, please read our blog post.

Investigational Devices Aim to Neutralize Key Cardiovascular Threats

2018 introduced new data on a litany of investigational cardiovascular devices, with several achieving varying levels of success.

In September, Abbott shocked the industry by releasing data on a new medical device that helps patients who have heart failure and severe functional mitral regurgitation. If these patients’ transcatheter mitral valves were repaired with Abbott’s MitraClip®, they experienced fewer rehospitalizations (the primary goal), and also decreased mortality two years after surgery. The results were so surprising as three weeks prior, the company announced that a previous MitraClip trial failed to show any benefit of the device. The lead investigator, Jean-François Obadia, said the more recent trial worked because the patients were in a more severe disease state and had already maxed out on their medications. He added, however, that the previous trial with less stringent enrollment criteria was more relevant to a real-life context. More testing is necessary to elucidate MitraClip’s true benefit.

Last May, Cerenovus announced the 510(k) clearance of MEBOTRAP™ II Revascularization Device, a stent retriever that can be used to capture and remove life-threatening blood clots from the brain following an ischemic stroke, the most common type of stroke. In clinical trials, physicians were able to restore blood flow within three passes in 80 percent of patients, and more than two-thirds of patients were functionally independent 90 days after treatment.

Ten days after this announcement, MicroVention announced the premarket approval of its LVIS® and LVIS® Jr. stents for stent-assistant coil embolization of intracranial aneurysms. The stent provides a channel through which small wires can be guided to the weakened spot of an artery to form a blockage (embolism) that will help prevent the blood vessel from rupturing. These stents are the first PMA-approved stents for stent-assisted coil embolization and the second PMA-approved device designed to treat intracranial aneurysms.

Another device undergoing clinical trials is ReCor Medical’s Paradise Ultrasound Denervation System. ReCor Medical announced their new pivotal study for the device, which is intended to treat hypertension, in July. The study is expected to finish in 2024.

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