FDA approvals; BP sensor system integrates in hearables, wearables

2020 is already busy with FDA approvals and clearances, most notably the approval of 3D-printed airway stents developed by Tom Gildea, M.D., a physician at the Cleveland Clinic who, along with his engineering team, use CT scans and proprietary 3D visualization software to 3D print patient-specific stents. In a time when health insurance companies are continuing the pressure to reduce costs, advancements such as this are answering while helping patients. In studies, the patient-specific stents lasted, on average, about a year versus 90 days for stock stents, and the patient-specific stents exhibited shorter procedure times. That’s a win for doctors, patients, and insurers.

There's a short video about the 3D-printed airway stents, but don’t skip over the rest of the news I’m offering up for brunch this weekend.

Another cool development released at the CES 2020 (Consumer Electronics Show) was Valencell’s blood pressure system, which the company will provide as a core technology to medical device and consumer electronics manufacturers for inclusion in their products. Yep, we have a video for this technology too.

So, enjoy the read, view some short videos, and enjoy the weekend!

FDA clearance of HA enhanced PEEK Interbody System, the EVOLha-DLIF

© Cutting Edge Spine | https://cuttingedgespine.com/

Cutting Edge Spine announced the 510(K) clearance and commercial launch of the latest addition to its bioactive portfolio of interbody systems, the EVOLha-DLIF direct lateral interbody fusion system.

The EVOLha-DLIF is made of PEEK-OPTIMA HA Enhanced material supplied by Invibio Biomaterial Solutions. Cutting Edge Spine implants made with this material have demonstrated early onset bone formation and apposition to its implants.

In addition to the EVOLha-DLIF, Cutting Edge Spine offers numerous other interbody fusion systems made with the PEEK-OPTIMA HA Enhanced material: EVOLha-C, EVOLha-ALIF, EVOSha. 

FDA approves Abbott heart pump alternative surgical technique, helping avoid open heart surgery

Abbott announced U.S. Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 Left Ventricular Assist Device (LVAD), the industry's leading heart pump.

© Abbott | https://www.abbott.com

Historically, heart pumps have been implanted via open heart surgery. With approval for an alternative surgical technique, Abbott's HeartMate 3 heart pump can now be implanted via lateral thoracotomy – a surgical approach where an incision is made between a patient's ribs to access the heart. Physicians believe that for many patients this technique has advantages over open heart surgery because it can result in less bleeding and a shorter recovery time for patients.

The approval is based on two studies – the ELEVATE study: a multi-center, voluntary, observational registry collecting post-marketing data, and the LAT Feasibility study: a single arm, prospective, multicenter study. Results of the two trials found that bleeding (requiring surgery), infection and arrhythmias were lower in the group implanted via the less-invasive surgical approach than those who underwent open heart surgery.

The HeartMate 3 received approval from the FDA in 2017 for patients with advanced heart failure whose hearts are unable to circulate blood through the body, and are waiting for a transplant, known as bridge to transplant. In 2018, HeartMate 3 was approved as a destination therapy for those individuals who are in need of a new heart but are not eligible for a transplant.

Valencell’s calibration-free blood pressure sensor system for hearables, wearables

Valencell announced the availability of the world’s first calibration-free blood pressure (BP) sensor system for integration in hearables and wearables. Valencell will provide the BP sensor system as a core technology to medical device and consumer electronics manufacturers for inclusion in their products. Embedded in an earbud reference design, the technology has demonstrated BP cuff-like accuracy through rigorous testing on thousands of patients and tens of thousands of datasets. The technology can recognize hypertension with 89% accuracy, which is more accurate than comparable technologies available today, and provides BP readings within +/-8mmHg for qualified datasets. In addition, the sensor system requires no calibration of any kind, meaning no BP cuff is ever needed to use this technology.

This breakthrough technology uses only photoplethysmography (PPG) and inertial sensors – no ECG, pulse transit time or other sensor modalities are used. It allows someone wearing an earbud to get accurate BP readings throughout the day, for example while they are at their desk at work, listening to music, or watching television, all without the hassle of putting on a BP cuff.

The BP sensor system was developed in partnership with Valencell’s strategic partner Sonion. Sonion and Valencell are also working on a version of this technology optimized for hearing aids and hearing health devices. Additionally, Valencell is conducting ongoing research and development to enable the technology in other form factors and body locations, including the finger and wrist.

FDA approves 3D-printed airway stents developed by Cleveland Clinic doctor

The U.S. Food and Drug Administration (FDA) has cleared patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea, M.D.

Until now, the patient-specific devices were being implanted under FDA’s compassionate use program, which allows patients who have failed all available forms of treatment to receive investigational ones not yet available to the public.

© Cleveland Clinic | https://my.clevelandclinic.org

The patient-specific stents developed by Dr. Gildea and his engineering team are designed using CT scans and proprietary 3D visualization software. The molds for the stents are then printed using a 3D printer and injected with medical-grade silicone. This process allows them to perfectly fit a patient’s anatomy.

“Breathing is something many people take for granted, but for many of these patients, every breath can be a struggle. It’s been gratifying to see patients receiving the customized stents feeling relief right away.” said Dr. Gildea, section head of bronchoscopy at Cleveland Clinic. “We are excited to be able to bring this technology to more patients across the country and grateful for the patients and donors who have worked with us to help pioneer this technology.”

Another advantage of the patient-specific silicone stents is they have the potential to be more tolerable than traditional silicone stents, which, in certain patients, may have to be frequently changed or cleaned due to problems from a poor fit. In studies, the patient-specific stents lasted, on average, about a year versus 90 days for stock stents. Furthermore, the patient-specific stents exhibited shorter procedure times and improved patient-reported symptoms, leading to a reduced need for stent changes and modifications.

Patient-specific products manufactured with 3D printing, including the airway stents, were named as one of the top 10 innovations at Cleveland Clinic’s annual Medical Innovations Summit in 2018. Dr. Gildea was also the recipient of the Outstanding Innovation in Medical Device award at the 2018 annual Inventor Awards Reception held by Cleveland Clinic Innovations.

With personalized medical devices more common in orthopedics, the patient-specific stent was developed and FDA cleared by an engineering team inside an orthopedic-focused Cleveland Clinic subsidiary. A new subsidiary named VisionAir Solutions will be formed around the technology with the sole mission of bringing more personalized medical devices to interventional pulmonologists and the patients who need them. By the end of the first quarter of 2020, this new spin-off company plans to begin providing the personalized stents to patients in a controlled launch at many of the country’s top medical institutions.