The idea of postmarket surveillance for medical devices isn’t new, but it did hit its stride this year. After a series of reports and meetings, a Medical Device National Evaluation System for health Technology (NEST) is starting to take shape. Creation of the system is one of CDRH’s Strategic Priorities for 2016-2017.
Earlier this year, the Duke-Margolis Center for Health Policy released a planning board report detailing the role of a Coordinating Center that would create the NEST. Then, in September, FDA awarded the Medical Device Innovation Consortium $3 million to lead the Coordinating Center—a strong sign that the reports are turning into reality.
CDRH director Jeffrey Shuren has described NEST as ideally using a neural network approach, “activating different kinds of networks depending upon the question that needs to be addressed.”
Real-world data and postmarket surveillance also played a role in a few key device approvals this year. Shuren pointed out that Edwards Lifesciences’s Sapien 3 transcatheter aortic valve received FDA approval and CE Mark for an expanded indication into intermediate risk patients several days apart—a far cry from the timelines for the original FDA approval, which followed CE Mark by more than four years. Real-world data was evaluated as part of that label expansion.
Patients with Diabetes
This year brought a few device approvals and launches that are meaningful for patient management of diabetes. In September, FDA approved Medtronic’s MiniMed 670G system, the first hybrid closed-loop system for insulin delivery, a big step toward the ultimate goal of an artificial pancreas. While not completely automated, the system is intended to keep patients within their target range for glucose levels as much as possible.
The MiniMed 670G is the fourth step in Medtronic's six-stage bid to create a closed-loop artifiical pancreas.
The same day, FDA also approved another futuristic device, the Abbott FreeStyle Libre Procontinuous glucose monitoring (CGM) system. Patients wear a sensor, which continuously measures glucose levels and records readings every 15 minutes, for as long as 14 days. This data is accessed and analyzed by their doctor during a visit. A consumer version is under FDA review.
In another positive for patients, traditional diabetes device companies have been partnering with tech giants to offer advanced capabilities. Medtronic teamed with Qualcomm Life this year while Dexcom partnered with Verily in 2015. Both duos are working on next-generation CGM systems. Medtronic and IBM Wat son Health also debuted their Sugar.IQ app, which identifies patient patterns and makes predictions.
The shift away from fee-for-service healthcare in the United States is not going to be easy, nor will it be complete any time soon. But CMS’s Comprehensive Care for Joint Replacement model is proof that the medical device industry can and will aid in the shift to value-based care.
CJR mandated that 800 hospitals near 67 urban centers around the country receive bundled payments for 90-day episodes of care around lower extremity joint replacement procedures—the most common inpatient surgeries covered by Medicare. The intention was to get stakeholders across the continuum of care to cooperate to help reduce costs and improve outcomes.
Device makers have answered the call. Orthopedics players, including Stryker, Zimmer Biomet, Smith & Nephew, and Johnson & Johnson, have rolled out tools ranging from lower priced implants to patient engagement programs and analytics platforms in an effort to help hospitals cope with bundled payments.
Next up, we’ll see what cardio companies can do. New rules proposed in July seek to expand the bundled payments model to cardiac care.
Edwards Lifesciences, MD+DI’s 2016 Medtech Company of the Year, has continued to push forward innovation in the transcatheter aortic valve replacement space.
Edwards's third-generation TAVR device, Sapien 3, won an expanded indication for use this year.
This year, data from the PARTNER II trial showed that the company’s Sapien 3 TAVR system demonstrated superiority over surgery in intermediate-risk aortic stenosis patients. A few months later, FDA approved an expanded indication for use of Sapien 3 in intermediate-risk patients; CE Mark for the label expansion followed weeks later. An IDEstudy of low-risk patients started this year, too.
Beyond TAVR, Edwards has set its sights on being first to the transcatheter mitral valve replacement (TMVR) opportunity, thought to be as large as four-and-a-half times the size of the TAVR market. In 2015, the company acquired CardiAQ Valve Technologies. An early feasibility study of the Edwards-CardiAQ TMVR platform is underway in the United States, and a CE Mark trial is expected to start before the end of the year.
The one downside of repeated successes? After numerous stellar quarters, the company posted third quarter sales results that missed analyst estimates. That miss resulted in a stock pullback, but most analysts continue to expect strong future TAVR growth.
Virtual reality is having a moment, and it’s not just for gamers anymore. From providing pain management and medical education to treating mental illness and guiding patients through physical therapy, perhaps the best use of this immersive technology is in the realm of healthcare.
This year brought a number of notable developments that prove virtual reality applications in medicine are starting to inch into the mainstream. Consider Boston-based startup SyncThink’s Eye-Sync virtual reality device for diagnosing concussions, which won FDA clearance in April. Users don the headset and follow a moving dot with their eyes. The device measures their eye movement to detect jitters that could signify a brain injury.
Earlier that same month, a London surgeon used Google’s Cardboard virtual reality headset to live-stream a 360-degree view of a surgical procedure to remove a tumor from a patient’s colon. Then, in July, West Hollywood, CA-based Applied VR partnered with Cedars Sinai Medical Center in Los Angeles to bring its Pain RelieVR virtual reality platform for to patients in the hospital’s spine, orthopedic, and surgery centers.
When Abbott Laboratories in January announced its plans to spend $5.8 billion to acquire Alere, the medical device giant seemed set for a major expansion of its $4.6 billion-a-year diagnostics business. Analysts, though, soon noted that Abbott might have challenges extracting real value out of Alere. Then came Alere’s March announcement that it had received a grand jury subpoena from the U.S. Department of Justice related to a U.S. Foreign Corrupt Practices Act investigation. Abbott officials—now also handling a proposed $25 billion acquisition of St. Jude Medical—started to show cold feet. Abbott even offered up to $50 million to walk away from the proposed merger, but Alere’s board rejected the offer. Abbott and Alere’s management have now taken the merger dispute to court. Alere has even gone as far as to claim that Abbott CEO Miles White threatened to make life a “living hell” for Alere if it didn’t accept the $50 million and walk away.
Count the U.S. Affordable Care Act as a major loser now that Donald J. Trump has been elected the next president of the United States. Trump has vowed to get an Obamacare repeal passed through Congress as soon as he is inaugurated, replacing President Barack Obama’s greatest legislative achievement with a to-be-determined program.
Some of the ACA’s more popular features, though, may end up being preserved. Trump told media outlets in the days after his election victory that he would like to see people with preexisting medical conditions keep their coverage, and he wants to work to keep the provision that allows young adults to stay on their parents’ health plans.
Time will tell whether other Obamacare measures affecting the medical device industry will remain, such as the push for more value-based payment methods under Medicare.
St. Jude Medical
In the first half of this year, St. Jude Medical looked like a winner, as it was scooped up by Abbottfor $25 billion.
The Unify Quadra CRT-D was among the St. Jude devices impacted by battery problems.
But in the second half of the year, the company was the subject of a research note claiming its cardiac devices were especially vulnerable to cybersecurity attacks and ought to be recalled. The research company, Muddy Waters, stood to profit from shorting St. Jude Medical’s stock and MedSec, a cybersecurity company that collaborated on the research, was to be compensated by the transaction. St. Jude Medical soon filed a lawsuit alleging false statements, false advertising, conspiracy, and the related manipulation of the public markets. The battle between the two sides has continued.
Battery issues have also beset the company. In October, doctors and patients were told that premature battery depletion had been observed in 0.21% of St. Jude Medical ICDs and CRT-Ds. Importantly, the absence of defibrillation therapy was also associated with two patient deaths. St. Jude Medical later voluntarily halted implants of its Nanostim leadless pacemaker because of a battery problem that led to loss of pacing and telemetry in seven of approximately 1400 devices.
TransEnterix was supposed to enter the U.S. robotic surgery market this year with its SurgiBot System, one of the hotly anticipated devices of the year. That system was expected to receive FDA 510(k) clearance in the first quarter of 2016, but in April, the company announced the agency had found the system not substantially equivalent to the predicate device.
TransEnterix's SurgiBot System was expected to receive 510(k) clearance this year but did not.
After the disappointment of not receiving 510(k) clearance, TransEnterix turned its focus to its ALF-X System, which it acquired from SOFAR S.p.A in 2015. The company had originally anticipated submitting a 510(k) for the ALF-X System, which has CE Mark, in the fourth quarter of 2016 and moved forward with that plan while continuing discussions with FDA about SurgiBot.
In September, ALF-X was rebranded as the Senhance Surgical Robotic System. TransEnterix management told analysts on the company’s November earnings call that more work is being conducted on usability studies of the Senhance System to improve the FDA 510(k) submission. That filing is now expected in early 2017, with FDA clearance still expected in 2017.
SurgiBot is still waiting in the wings. Management believes future 510(k) clearance is possible for that system, though any plans will be considered after the Senhance submission.
Ovarian Cancer Screening Tests
During September—ironically, Ovarian Cancer Awareness Month— FDA published a warning against the ovarian cancer screening tests on the market. The agency wrote that “there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results.”
Abcodia, maker of the ROCA ovarian cancer screening test, sold the test in the UK and in many U.S. states. The test was marketed as a way to determine the likelihood of ovarian cancer in postmenopausal women from 50 to 80 years old and women with a higher risk between 35 and 85 years old. The ROCA test was studied in more than 200,000 patients during the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Data on the test includes detection of 85.8% of ovarian cancers, 99.8% efficacy in determining women who do not have ovarian cancer, and detection of twice as many ovarian cancers as the CA-125 blood test.
Following FDA’s safety communication, Abcodia announced it would voluntarily and temporarily suspend U.S. commercial availability of the ROCA Test. The company also announced it would temporarily limit availability of the test in the UK. Abcodia reiterated its confidence in the test’s clinical utility and emphasized its use as a risk estimation tool, not a standalone diagnostic test nor for general population screening.
In a statement, a group of UKCTOCS trial investigators outlined the evidence on the test, including the significant increase in detection of early stage cancers using multimodal screening versus no screening.