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Articles from 2017 In February

How A New Blood Test Could Forecast Heart Attacks

Data published in the Journal of the American College of Cardiology shows a new blood test detected a significant coronary obstruction 90% of the time, and also tipped doctors off to a patient's risk of a future heart attack.

Amanda Pedersen

A Massachusetts General Hospital cardiologist said Prevencio Inc.'s multi-protein blood test could represent a new standard of care for diagnosing heart disease and predicting heart attack risk. 

A new blood test could change the way doctors diagnose heart disease, and potentially offer a heads up about future heart attacks. According to data published in the Journal of the American College of Cardiology, the test is substantially more accurate for heart disease diagnosis compared to standard diagnostic methods like ECG and nuclear stress testing, and results are delivered in just two hours.

Kirkland, WA-based Prevencio Inc. developed the multi-protein blood test with researchers from the Massachusetts General Hospital to diagnose a patient's likelihood of having coronary artery disease (CAD), which could require invasive intervention to prevent a possible heart attack or death.

James Januzzi, a cardiologist at Massachusetts General Hospital and a professor of medicine at Harvard Medicine School, led a team of researchers that tested more than 900 patients for the presence of obstruction of 70% or more in at least one major coronary artery, which is the threshold for medical intervention. A positive result with the new test indicated the presence of significant coronary obstruction 90% of the time, and also tipped the clinicians off to a patient's risk of a future heart attack.

"These are significant results which have the potential to establish a new standard of care and the potential to save millions of lives," Januzzi said.

He said better diagnostic and predictive methods could lead to earlier therapy and lifestyle changes, which in turn could prevent heart attacks and improve a patient's quality of life.

Prevencio said standard diagnostic methods such as ECG and nuclear stress tests are problematic because they can be inaccurate in women and obese patients, and nuclear tests expose patients to ionizing radiation. These standard methods are not cheap either. A cardiac CT angiogram procedure runs about $2,000 on average, and a cardiac catheterization costs roughly $47,000 on average in the United States. Pointing to other research published in the New England Journal of Medicine, almost 65% of patients are needlessly referred for invasive coronary catheterization.

In addition to the Hart CAD test for diagnosis, Prevencio is developing blood tests for predicting, and ideally preventing, the likelihood that a patient will have a heart attack, stroke, or cardiovascular death within one year.

Prevencio is developing its standardized lab test for Hart CAD and plans to conduct FDA trials in 2018, then file for European and FDA approval between 2018 and 2019.

Current cardiac blood tests are designed to analyze one individual protein at a time, but Prevencio's tests are designed to analyze multiple proteins and algorithmically scores a patient to determine the absence or presence of heart CAD, as well as predict their one year risk for heart attack, stroke, or cardiovascular death.

While the ultimate goal of Prevencio's tests is to prevent heart attacks, other companies are working on ways to improve the diagnosis of heart attacks that are already happening. Last year, for example, Philips introduced a heart attack detector that runs on one drop of blood.

Amanda Pedersen is Qmed's news editor. Contact her at

[Photo courtesy of Pixabay]

Updated Blood Collection Device Draws 510(k) from FDA

FDA cleared Velano Vascular's PIVO needle-free blood collection device, which attaches to a peripheral IV system.

Nancy Crotti

The PIVO advances an inner tube via a slider mechanism through the peripheral IV catheter system.

Velano Vascular has won 510(k) clearance for a next-generation version its blood-draw device aimed at reducing painful needle sticks.

The PIVO, formerly called TIVA, is a  single-use, needle-free blood collection device that attaches to a peripheral IV system.The device, which comes in 20- and 22-gauge sizes, advances an inner tube via a slider mechanism through the peripheral IV catheter system. PIVO possesses a proximal flexible tube with female luer that attaches to a blood transfer device or syringe, into which a blood sample is collected.

FDA, which helped with development of the original device through a grant to the New England Pediatric Device Consortium, approved the first version in early 2015. The San Francisco--based company spent 18 months working on updates that would make it easier to use and scalable for global distribution, according to co-founder and CEO Eric Stone. The PIVO is simpler and requires fewer steps for nurses, phlebotomists, and medical office staff.

"We removed a significant number of components," Stone told Qmed. "We removed an adhesive with multiple bonds, and we redesigned for full automation."

The device is in use in six or seven hospitals or health systems in the United States, he noted. Both versions have received the CE mark, and Stone said the company would be ready to discuss global distribution later this year.

The 20- and 22-gauge PIVO devices may be used with adult patients, while the 22 works with some children and with adults. Velano is working on developing a 24-gauge size for smaller children.

"The results in pediatrics are certainly promising," Stone said. "I very much expect we will develop this procedure as standard of care for pediatrics."

Stone knows how much pain and anxiety needle sticks can cause patients, especially pediatric patients. As a child with Crohn's disease, he underwent multiple hospitalizations and many needle sticks.

The company designed the first version of PIVO to show that it could come up with an effective technology to produce strong blood draws from a peripheral IV, according to Stone. Now that it has done so, Velano wants to make that technology more widely available.

"First and foremost, to develop a new standard of care requires observing, listening, asking, learning, and iterating," Stone said. "In order to establish the standard of care for such a broad-based and pervasive procedure, the technology has to be scalable from a usability perspective and from a manufacturing perspective, so we can meet demand."

Nancy Crotti is a freelance contributor for Qmed.

[Photo credit: Velano Vascular]

Medical Device Executives on ACA Uncertainty and More

Well-known medtech executives discussed the potential impact of specific policy changes that may be implemented under the Trump administration.Marie ThibaultAs medtech companies reported their quarterly earnings over the past month, executives were asked repeatedly about the potential impact of specific changes that may come out of Washington, D.C. This includes the possibility of “repeal and replace” of the Affordable Care Act, a border tax, corporate repatriation, and other issues.Read on to learn what the biggest names in the medtech industry are saying about these potential changes.[Image courtesy of PUBLICDOMAINPICTURES/PIXABAY]

Well-known medtech executives discussed the potential impact of specific policy changes that may be implemented under the Trump administration.

As medtech companies reported their quarterly earnings over the past month, executives were asked repeatedly about the potential impact of specific changes that may come out of Washington, D.C. This includes the possibility of “repeal and replace” of the Affordable Care Act, a border tax, corporate repatriation, and other issues.

Read on to learn what the biggest names in the medtech industry are saying about these potential changes.


Medtronic Solitaire Passes Muster In The Real World

Real-world experience with Medtronic's Solitaire stent retriever in patients suffering acute ischemic stroke shows the device can perform just as well in the real world as it did in four separate clinical trials.

Amanda Pedersen

Registry data presented at the International Stroke Conference showed Medtronic's Solitaire stent retriever performed as well in real-world clinical settings as it did in four separate randomized controlled trials.

No matter how well a device performs in clinical trials, the true test of its effectiveness is how well it performs in the real world, outside of the strict confines of a well-designed study. Medtronic's Solitaire stent retriever recently stood up to that test by demonstrating that the results from four pivotal randomized controlled trials can be replicated in a pragmatic, real-world setting for patients suffering acute ischemic stroke (AIS).

Study investigators presented the results from the Systematic Evaluation of Patients Treated with Neurothrombectomy Devices for Acute Ischemic Stroke (STRATIS) registry last week at the International Stroke Conference in Houston. The STRATIS registry confirmed earlier results from the Dublin-based company's SWIFT PRIME, ESCAPE, EXTEND IA, and REVASCAT trials.

"In medicine, you see a lot of times that when trials are run they're incredibly stringent, and patients get incredibly good follow up, and then you find out that that trial, the way it was run, is not always applicable in the real world," Curtis Given, co-director of neurointerventional services at Lexington, KY-based Baptist Health, told Qmed. "So this was really important because STRATIS was close to 1,000 patients in 55 centers and it showed that you couold have the same outcomes, the same effect on patients' lives, with this device in the real world and not under the confines of a clinical trial."

Medtronic said the STRATIS registry examined the impact of treatment delays on patient outcomes when treated with the Solitaire stent retriever and intravenous tissue plasminogen activator (IV-tPA), if eligible. In the study, 984 patients were enrolled at 55 U.S. centers, with 64% treated with the Solitaire stent retriever and IV-tPA and 36% treated with the Solitaire stent retriever alone. The study showed that inter-hospital transfer was associated with significant treatment delays and significantly lower chance of functional independence at 90 days (60% compared to 52.2%, p=0.02).

Also, patients treated with a balloon guide catheter had higher rates of functional independence at 90 days (61.8% compared to 50.2 percent, p=0.002) with fewer passes (1.7 compared to 2.0, p=0.0008) than patients treated with a distal access catheter.

There are currently several different devices on the market designed to treat stroke, but Given said the Solitaire stent retriever stands out from the rest of the pack as the most studied device of its kind and the one that is supported by the most randomized data.

"One of the problems with devices in general in stroke therapy is there are lots of things that can remove blood clots from the head," Given said. "And often we judge and say 'okay, we removed the blood clot, that's great, this device works great.' But then when you look at the thing that's important, which is 'did removing the blood clot, did restoring the blood flow, and how you removed the blood clot, did that actually result in a positive benefit to the patient? Solitaire is by far the device that has been studied the most in that aspect."

Solitaire has achieved good clinical outcomes beyond the ability to restore blood flow, Given said.

It came as no surprise to Given that the STRATIS registry data also highlighted the importance of first responders being able to recognize patients with large vessel occlusion and massive strokes and transporting them not to the nearest hospital, but to the nearest hospital capable of removing their clot and restoring blood flow.

Amanda Pedersen is Qmed's news editor. Contact her at

[Image credit: Medtronic plc]

7 M&A Trends from 2016 and Predictions for the Year Ahead

Medtech companies do not appear to be letting off the M&A gas pedal any time soon. Based on EvaluateMedTech data, EP Vantage recently released its annual report, Medtech 2016 in Review, offering an analysis and expert commentary on M&A deals, venture financing, initial public offerings, and FDA approvals in the industry during 2016. The report also offers some key predictions for the year ahead.

Medtech companies do not appear to be letting off the M&A gas pedal any time soon. Based on EvaluateMedTech data, EP Vantage recently released its annual report, Medtech 2016 in Review, offering an analysis and expert commentary on M&A deals, venture financing, initial public offerings, and FDA approvals in the industry during 2016. The report also offers some key predictions for the year ahead.

How a Brain Implant Helped Three People Text

Stanford engineers and neurosurgeons have developed a new experimental brain-controlled technology designed to help paralyzed patients channel thoughts into movement and speech.

Kristopher Sturgis

Stanford's Jaimie Henderson and Krishna Shenoy are part of a consortium working on an investigational brain-to-computer hookup.

A project nearly 15 years in the making is beginning to come to fruition for a group of Stanford researchers who have been working tirelessly to create a new brain-computer interface (BCI) device that can be implanted into the brain to help restore speech and movement abilities to patients suffering from paralysis or severe movement disabilities.

The device has been introduced to three movement-impaired individuals as part of a new clinical trial, and has already begun to produce remarkable results. The device, which measures about the size of a baby aspirin, was implanted into the brain of each participant to record signals from their motor cortex -- the region of the brain that controls muscle movement. The signals were then transported to a computer and translated by algorithms that could guide a cursor to characters on a keyboard. The end result was a technique that enabled all three patients to compose and send text messages through the power of thought.

After some brief training, each participant was able to master the technique enough to outperform the results of any previous BCI technique designed to enhance communication for movement-impaired patients. The group also noted that these patients achieved these unprecedented typing rates without the use of any automatic word-completion assistance, a common electronic keyboard application that could eventually boost their performance even further.

Efforts to explore brain-computer interface technologies have continued to expand over the years as researchers aim to leverage new technologies as a means to bypass brain and spinal injuries that impair movement. In 2015 doctors from Case Western Reserve University in Ohio were able to use a wireless brain-computer interface system in tandem with electrodes implanted into the arm of a patient to restore movement to a once-paralyzed limb. The project marked a significant advancement in BCI technologies, specifically those using wireless transmitters to execute thought-based commands.

While this new technology uses a cable to transmit signals from the brain to a computer, the algorithms that translate the signals to point-and-click commands are what enable the patients to control cursor movement with unprecedented speed and dexterity. Researchers say the approach could even be applied to a bevy of different computing devices without significant modifications, including tablets and smartphones.

Despite the success of the recent trials, the group maintains that a significant amount of work lies ahead, as they intend to expand the types of devices people can operate with the BCI implant. Their goal is to eventually create a device that can enable movement-impaired patients to use a variety of off-the-shelf assistive devices to help them interact with the world around them. In time, the researchers believe the device could completely change how we treat paralysis, nervous system disorders, and other movement disabilities, improving their lives unlike ever before.

Kristopher Sturgis is a Qmed contributor.

[Image credit: Paul Sakuma, Stanford]

Check-Cap Is Ready for the Next Phase

Check-Cap Is Ready for the Next Phase

As Check-Cap starts its clinical trial for CE Mark on its prep-free C-Scan imaging capsule for colorectal cancer screening, the company's CEO discusses the technology's potential.

Good news for--well, all of us. Check-Cap's C-Scan system for colorectal cancer screening without the need for a bowel prep is ready to enter the clinical performance phase of development.

After being swallowed in capsule form, the C-Scan system's ultra-low-dose X-ray technology is used to produce a 3-D map of a patient's colon. The system differs from capsule technology already on the market by eliminating the need for a bowel prep prior to ingestion and examining the colon in its natural state without distention.

In January, the company announced it had enrolled its first patient in a trial to support a CE Mark. According to the press release and a recent company presentation, this 100-person, multi-center prospective trial is focused on safety and clinical performance--polyp detection--of the system.

Learn about emerging medtech technologies at Advanced Design & Manufacturing Cleveland, March 29-30.

"We've put a lot of work into getting the technology to a very stable and reliable place and moving past the technology risk. We are now entering the phase to assess the clinical performance, which we're very happy to be in," Bill Densel, CEO of Check-Cap, told MD+DI during a January interview.

Check-Cap anticipates submitting the C-Scan system for CE Mark by the end of the first half of 2017, Densel said. Although Check-Cap has just started its CE Mark trial, the trial timeline may move quickly, since there aren't months of follow up needed. After all, patients just need to receive the C-Scan system and receive a colonoscopy to study the technology's polyp detection capabilities.

"There is no three months, six months, nine months [follow up]," Densel said. "We can proceed, hopefully, and move quickly through that."

After receiving CE Mark, the company will likely conduct a postmarket clinical study to increase the body of evidence on the system's performance. Densel explained that this data would be used to support commercialization, which Check-Cap hopes to undertake with a partner in Europe. "We wouldn't be looking to do that on our own," he said. 

A commercial launch of the C-Scan system could come as soon as the first half of 2018, according to a recent company presentation, though that timeline would depend on factors including regulatory go-ahead, capital needs, and a strategic partnership.

The C-Scan system doesn't require patients to take laxatives and undergo bowl prep before taking the capsule because the ultra-low-dose X-ray technology can see through the contents of the colon. Patients take a small amount of contrast agent while the capsule moves through the gastrointestinal system. This means that the colon wall can be set apart from any food in the colon.

The system produces a 3-D contour map of the colon that can be viewed in different ways to look for polyps, including a "tube" view (seen in the image at right), a flat "fillet" view, or even the outside of the surface of the colon wall. There's other data from the system that may help clinicians detect polyps too, including Compton backscatter, X-ray fluorescence, and pressure data. If polyps are seen, a colonoscopy would likely be prescribed.

Check-Cap is making moves toward the U.S. market, too. In December, the company's management met with FDA to discuss a pathway toward regulatory approval. That discussion was the first step toward determining whether the C-Scan system will be a PMA or 510(k) de novo technology. A U.S. pilot trial could start as soon as the third quarter of 2017.

Densel envisions the C-Scan system filling a void for those patients who aren't being served by current commercial options for colorectal cancer screening. While there are convenient options for screening, those tests don't offer the high accuracy level of a colonoscopy. Then again, a colonoscopy brings with it issues of bowel prep, sedation, a day off work, and other inconveniences, he noted.

"We'll bring something that's more convenient, less uncomfortable, less anxiety-producing, less invasive, but [has] a high accuracy toward pre-cancerous polyps," Densel said.

"We have a lot of support from patient advocacy, other important leaders, to say that this just makes so much sense. Why wouldn't we look to help people get this option? . . . I think our story makes sense to a lot of people," Densel said.

[Image courtesy of CHECK-CAP LTD.]

How to Exempt Your Firm from Cybersecurity Reporting Requirements

Cybersecurity is a concern for connected medical devices, but not all risks are apparent--or materialize--until after a product is on the market. FDA therefore expects manufacturers to address cybersecurity "throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device," the agency wrote in its December 2016 guidance, "Postmarket Management of Cybersecurity in Medical Devices." 

The guidance clarified FDA's enforcement plans and urges industry collaboration, but one of its recommendations--participation in an Information Sharing Analysis Organization (ISAO)--wasn't necessarily available for medical device manufacturers. Until now.

The agency stated in the guidance that if you're a member of an ISAO, certain reporting requirements may not apply. "But there weren't any ISAO's focusing on medical device manufacturers, so we decided to form one," Frances Cohen, president of Promenade Software Inc., told MD&DI.

In January, Promenade Software launched MedISAO (, an Information Sharing and Analysis Organization dedicated to improving the cybersecurity of medical devices through education, awareness, and advocacy, the company explained in a statement. Individuals and companies involved in design, manufacturing, or support of medical devices are invited to join MedISAO to collaborate and distribute information about cybersecurity threats and vulnerabilities that may affect device integrity and security.

To run such a community, Promenade set up a "forum and Web site and put processes in place," Cohen explained. Members receive ongoing cybersecurity risk and threat information. Given the firm's experience developing embedded medical device software, "We know exactly how certain software patches apply to medical devices, and we can filter out patches so that only the serious ones are included," she explained. 

The community is designed for both experts and novices. "It is a place to share information that would be protected," Cohen says. The community will help members evaluate vulnerabilities, share applicable response approaches, and promote best practices.

MedISAO's mission seems to be in keeping with FDA's expectations. According to the guidance, "ISAOs are intended to be: Inclusive (groups from any and all sectors, both non-profit and for-profit, expert or novice, should be able to participate in an ISAO); Actionable (groups will receive useful and practical cybersecurity risk, threat indicator, and incident information via automated, real-time mechanisms if they choose to participate in an ISAO); Transparent (groups interested in an ISAO model will have adequate understanding of how that model operates and if it meets their needs); and Trusted (participants in an ISAO can request that their information be treated as Protected Critical Infrastructure Information. Such information is shielded from any release otherwise required by the Freedom of Information Act or State Sunshine Laws and is exempt from regulatory use and civil litigation if the information satisfies the requirements of the Critical Infrastructure Information Act of 2002."

Voluntary participation in an ISAO "is a critical component of a medical device manufacturer's comprehensive proactive approach to management of postmarket cybersecurity threats," wrote FDA. "For companies that actively participate in such a program, and follow other recommendations in this guidance, the Agency does not intend to enforce certain reporting requirements of the Federal Food, Drug, and Cosmetic Act."

FDA offered several examples of device vulnerabilities associated with both controlled and uncontrolled risks of patient harm. In one example, "a manufacturer is made aware of open, unused communication ports," and "analysis determines that the device's designed-in features do not prevent a threat from downloading unauthorized firmware onto the device." In this narrative, "the manufacturer communicates with its customers, the ISAO, and user community regarding the vulnerability, identifies and implements interim compensating controls, develops a remediation plan, and notifies users within 30 days of becoming aware of the vulnerability," FDA explained. "If the manufacturer actively participates as a member of an ISAO and shares information about the vulnerability within the ISAO, FDA does not intend to enforce compliance with the reporting requirements in 21 CFR part 806. For class III devices, the manufacturer does submit a summary of the remediation as part of its periodic (annual) report to FDA."

When it comes to ensuring cybersecurity, Cohen told MD&DI that "FDA is putting the responsibility on manufacturers, not on hospital IT departments. Some companies have been nailed for vulnerabilities."

She has heard companies push back, making statements such as "I'm a small guy, do I care? Will I be targeted?"

She responds by saying, "If you're part of the ecosystem, you are making everyone vulnerable."


Daniel Beard, Director of MedISAO and Vice President of Technology for Promenade Software, said in a statement that "as medical devices become connected to networks, mobile platforms, and the cloud, security becomes paramount. Cybersecurity vulnerabilities create risks for patients and the community. As Director of MedISAO, I am committed to helping preserve patient safety and trust."

Promenade Software spoke with MD&DI just before MD&M West 2017, where the software provider demonstrated "Parlay." The solution is designed specifically for the needs of medical devices to provide secure connectivity between the instrument, mobile (Andriod and iOS), and cloud. It embeds instrumentation and remote diagnostics capabilities into the system at every level, giving developers, researchers, testers, manufacturers, and field service technicians the ability to "see" into the inner workings of the device and diagnose or characterize system behavior, the company stated.

For perspectives on medical device development, plan to attend the conference at Advanced Design & Manufacturing Cleveland March 29-30. You'll learn about the journey from product conceptualization to market entry as well as the emerging technologies that are changing the future of the healthcare landscape.

Shareholders Punish Boston Scientific For Latest Lotus Recall

Boston Scientific pulled all of its Lotus valves from the market based on reports of a mechanical mishap with a pin connecting the valve to the delivery system. The recall could delay the U.S. launch of the Lotus Edge valve by about six months.

Amanda Pedersen

Boston Scientific's latest Lotus problem could delay the U.S. launch of Lotus Edge by about six months

Shareholders didn't hold back on punishing Boston Scientific after the company removed all Lotus valves from the market after getting reports of a mechanical problem with a pin that connects the valve to the delivery system. The stock (NYSE: BSX) plunged 9.4% ($2.37) to $22.79 in premarket trading, but to $24.14 by midday.

The premature release of a pin connecting the Lotus valve to the delivery system is similar to the problem Boston Scientific had last year with its Lotus Edge valve system. Like with the Lotus Edge recall, the Marlborough-based company said in an SEC filing that the current problem is believed to be caused by excess tension in the pin mechanism introduced during the manufacturing process. The Lotus Edge received a CE mark last September, about a month after the company previously recalled the device.

Boston Scientific said it expects to bring the Lotus valve platform back to market in Europe and other regions where the device is approved in the fourth quarter. The company said it also plans to file for FDA approval of the Lotus Edge valve in the fourth quarter, and is now aiming for a U.S. launch of the transcatheter aortic valve replacement (TAVR) system in mid-2018, about six months later than previously expected.

Mike Matson, a medtech analyst at Needham & Company, said the latest Lotus problems are disappointing, but he thought the stock sell-off was overdone. "We still expect Lotus to be a differentiated share-taker," Matson said in his report Thursday.

The Lotus valve has achieved very low paravalvular leak rates 

Pin problems are not the only thing plaguing Boston Scientific this week. On Tuesday the U.S. Supreme Court rejected the company's appeal of a Maryland state court jury verdict in 2014 ordering the device maker to pay $308 million in royalties and damages to Bethesda, MD-based Mirowski Family Ventures for breaching a licensing agreement related to implantable cardiac devices. Guidant Corp. had licensed the patents before Boston Scientific's $27 billion acquisition of Guidant in 2006.

Boston Scientific first appealed to the Maryland Court of Appeals but the appeals court refused to hear the case last July. Then, Boston Scientific turned to the Supreme Court, asking the justices to hear its appeal and arguing that the Maryland court made mistakes applying patent law. The judge in the Maryland Circuit Court refused to interpret the meaning of one of the patents, the company said.

Amanda Pedersen is Qmed's news editor. Contact her at

[Image credit: Boston Scientific Corp.]

J&J to Swallow Up GERD-Prevention Device Maker

Torax Medical makes a magnetic device that keeps stomach acid in place.

Nancy Crotti

A subsidiary of Johnson & Johnson is buying a small company that makes a surgical solution to gastrointestinal reflux disease (GERD).

Cincinnati-based Ethicon, Inc. announced the purchase of competitor Torax Medical, Inc.,a privately held company in Shorewood, Minn., for an undisclosed sum. Torax makes the Linx Reflux Management System, a minimally invasive device made of interlinked titanium beads with magnetic cores. The ring-like device augments the action of the lower esophageal sphincter, which keeps stomach acids from entering and damaging the esophageal lining. GERD is associated with a condition known as Barrett's esophagus, which increases the risk of esophageal cancer.

Keep track of who bought who in the medical device and diagnostic industry last year with our free Medtech Mergers and Acquisitions of 2016 report.

Developed at the Mayo Clinic, the Linx device landed FDA approval in 2012. Linx is used by physicians in more than 300 hospitals in the U.S. and Europe, according to a statement by Ethicon.

Linx provides an alternative to laparoscopic Nissen fundoplication surgery, in which the upper curve of the stomach, known as the fundus, is wrapped around the esophagus and sewn in place. The procedure leaves the lower portion of the esophagus to pass through a small tunnel of stomach muscle.

Torax also makes the Fenix continence restoration device that treats fecal incontinence, also using magnetic titanium beads. Implantation of Fenix requires a surgical procedure. The most common cause of fecal incontinence is damage to the muscles around the anal sphincter from vaginal childbirth or functional disorders such as diabetes.

FDA approved the Fenix device for humanitarian use in December 2015 for patients who are not candidates for, or have previously failed, medical or other surgical options.

Torax has an estimated annual revenue of $15.9 million, according to a report by the Cincinnati Business Courier. The company announced last August that it had completed a $25 million round of Series E financing that was led by J&J. Other investors included Sanderling Ventures, Thomas McNerney & Partners, Accuitive Medical Ventures, Kaiser Permanente Ventures, Piper Jaffray Companies, and Mayo Clinic Ventures, according to a company statement. Torax used the funds to scale its products, the report said.

Ethicon said it decided to acquire Torax as part of a strategy to invest in areas of unmet medical needs, such as esophageal health. The company expects the transaction to close during the first quarter of 2017. Torax did not respond to requests for comment.

Nancy Crotti is a freelance contributor to Qmed.