The global medical device industry enjoyed another dynamic year in 2019. The past 12 months were marked by a spectacular rise of new trends and technologies, notably across digital health, wearables and robotic surgery, as well as regulatory upheaval.
As the end of the year is coming closer, it is time to look back and see which were the major highlights across funding, innovations, clinical trials, mergers, acquisitions and regulatory approvals in our annual editors’ recap.
Innovations
Reliable and useful consumer-oriented ECG monitoring is no longer a thing of the past. Alivecor, a California-based medical device and AI company that develops hardware and software for mobile devices launched this year the world’s first 6-lead consumer ECG, the KardiaMobile 6L. The KardiaMobile 6L resembles a large USB memory stick with two electrodes on one side and one on the other, and comes at the very reasonable price of $149.
Another non-invasive device called Hummingbird increases daily activity of people with fibromyalgia, while reducing muscle pain as reported by its developer, North Carolina-based company Vital Motion. The device is placed under the front part of the feet and emits a gentle vibration, providing pain relief and up to 72.7% increase in daily activity levels in patients. Fibromyalgia is a long-term condition characterised by widespread sensation of pain, accompanied by fatigue, sleep, memory and mood issues. Nearly 6 million Americans are estimated to be affected by the condition.
Regulatory Approvals
Infections in the fluid surrounding joint replacements can lead to pain, swelling and decreased function and may require surgery for treatment and a new prosthetic implant. A new diagnostic tool to help determine whether swelling around a prosthetic joint replacement is being caused by an infection was cleared by the FDA earlier this year. The Synovasure test kit—manufactured by CD Diagnostics, which was acquired by Zimmer Biomet in 2016—takes a sample from the viscous, lubricating fluid that surrounds the joint and searches for antimicrobial proteins released by white blood cells. The test kit has been designed for patients under evaluation for a failing implant revision or replacement surgery.
Digital therapeutics firm Neurolief secured the European CE-Mark to market, sell and distribute its Relivion device as a digital migraine treatment. Relivion has been developed as a non-invasive, multi-channel brain neuromodulation technology that is said to deliver therapy similar to surgical implants. The cloud-enabled, system is linked to a mobile phone app and comes with an adjustable headset that simultaneously delivers modulated pulses through adaptive output channels around the head to six branches of the occipital and trigeminal nerves.
Mergers & Acquisitions
Boston Scientific moved into the orthopedics space with a $465 million buyout of spinal implant maker Vertiflex.
Siemens Healthineers agreed to buy US medtech Corindus for $1.1 billion. Massachusets-based Corindus builds surgical robots to assist surgeons with operations on veins and arteries.
Smith & Nephew closed its acquisition of Brainlab, boosting its orthopedic joint replacement business. Smith & Nephew will begin integrating the Brainlab platform into the next version of its robotic surgery platform, Navio 7.0.
Exactech expanded its reach in the foot and ankle market with the acquisition of medical device company EPIC Extremity, which designs bone and joint restoration products and biologic solutions for extremities, knees and hips.
Pharmaceutical giant AbbVie announced the acquisition of Allergan in a $63 billion deal. Combined, the companies would rank as one of the industry’s largest by revenue.
3M entered an agreement to acquire Acelity Inc. and its KCI subsidiaries worldwide for a total enterprise value of some $6.7 billion. Acelity is a global leader in advanced wound care solutions and specialty surgical applications marketed under the KCI brand.
Clinical Trials
Abbott announced the launch of the TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of the company’s TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). This is the first pivotal Investigational Device Exemption (IDE) trial in the U.S. to evaluate a catheter-based, non-surgical treatment for patients with severe TR – a condition in which the valve doesn’t close properly, allowing blood to flow backward into the heart, forcing the heart to work harder. In the U.S. alone, approximately one in 30 people over the age of 65 have moderate to severe TRiv.
A series of pilot clinical studies has indicated that non-invasive external stimulation of the vagus nerve alleviates disease symptoms in patients with rheumatoid arthritis (RA). Vagus nerve stimulation (VNS) involves delivering electrical impulses to the vagus nerve, one of the cranial nerves that connects the brain to the body. VNS devices can either be implanted under the skin in a pacemaker-style device which sits on the chest, or external devices which are held up to the neck and manually activated to deliver electrical impulses.
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