Are You Really Ready For MDR?

Pixabay Are You Really Ready For MDR?

Audrey Turley doesn’t shy away from speaking about biocompatibility topics related to medical devices. Turley serves as a senior biocompatibility expert for Nelson Labs. The Salt Lake City, UT-based lab serves as an independent consultant that can help navigate these changes for firms.

Turley will be speaking at MD&M Minneapolis today about Assessing Biocompatibility for Medical Devices. During an interview with MD+DI, she pointed out two main changes in the biocompatibility – the move to the new European Medical Device Regulation (MDR) and the switch from animal to in vitro testing.

“The first is about changes happening in the biocompatibility realm of medical devices and how to address those changes,” Turley told MD+DI. “The second one is about assessing biocompatibility in medical devices in general, where I’m just going to outline the overall approach.”

As it stands now, all medical devices must comply with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD). But by 2020, this will change and new medical device products distributed within Europe must comply with the new European Medical Device Regulation (MDR).

“Some of our biggest issues are the new MDRs that are coming out that are asking for recertification from every medical device that is marketed in Europe,” Turley said. “This isn’t just for new [devices] but for existing ones too. Europe is doing away with the grandfather clause where you can grandfather in medical devices as they change regulation. It’s amazing to do this on such a grand scale where its affecting everything on the market. That’s the biggest topic right now in biocompatibility.”

It has been said that Europe’s MDR is the most significant change to the regulatory framework in the medical device industry since CE Marking was introduced in 1993.

In an article published in MD+DI, Feb. 12, 2018, its author Peter Rose wrote that combined with the complexity and breadth of the required changes, it is imperative that medtech companies put their compliance plans into motion now.”

Nelson labs is gearing up for the deadline and the increased volume of companies it can help.

“We’re ramping up our services and making sure we’re available to meet these really tight deadlines,” she said. “The goal really from a medical device company standpoint is the hope as we see as a laboratory is that they will start sooner rather than later.”

Turley will also talk about how testing is moving more toward in vitro models.

She noted that in vitro methods for testing have been used for years for cosmetics and chemicals. However, the difficult thing about medical devices fully adapting in vitro models over animal testing is that it’s not always known what the patient exposure is going to be.

“We can state everything that’s in that medical device but we don’t know what’s coming off the device into the patient,” she said. “It’s a very complex system to understand and then try to predict a biological response. When we think about it like that and understand the complexity, it’s not a straightforward approach as far as finding an in vitro or alternate method.”

Turley said the creation of bench top models has removed some of the complexity of testing.

“A great test to talk about is the Irritation Assay,” she said. “We have found that there is an in vitro model that uses three-dimensional skin. What happens is that they can take a layer of cells and grow it in a way that the cells will differentiate into the types of skin cells as we have as humans. It’s great because we can take out the issues of variability.”

Financing Allows Endotronix to Take Big Step in Treating HF

Pixabay Financing Allows Endotronix to Take Big Step in Treating HF

Endotronix just received a huge shot in the arm when it comes to supporting the commercialization of its heart failure system. The Lisle, IL-based company just closed on a series D financing round of $45 million.

This financing supports the commercialization of the Cordella Heart Failure System (Cordella System) and clinical development of the Cordella Pulmonary Artery Sensor (Cordella Sensor) through CE Marking and a PMA.

The product platform consists of a comprehensive remote patient management software solution coupled with an implantable pulmonary artery sensor to streamline heart failure care management and provide early detection of worsening heart failure.

The company said the patient management software is approved for use in the US and the system is currently in commercial use . Endotronix is on track to have CE Mark on the patient management system in 4Q18. The Cordella PA Sensor, is in an on-going first-in-human study in Europe. The company plans to start a CE Mark study in 4Q18 and have an IDE study in the US in early 2019.

"We are thrilled with the world-class leadership and support of LSP and our existing investor group as we launch into the next phase of our company,"  Harry Rowland, CEO of Endotronix said in a release. "This financing accelerates our U.S. and E.U. launch of the Cordella System and supports our upcoming landmark randomized, controlled clinical study, PROACTIVE-HF, to demonstrate the safety and effectiveness of proactive heart failure management."

Just Where Does Apple’s New ECG Fit into the Market?

Pixabay Just Where Does Apple’s New ECG Fit into the Market?

The inclusion of two heart monitoring apps with the upcoming Apple Watch 4 is causing quite a stir in the wearable device market. Last week, Cupertino, CA-based Apple revealed it received nods from FDA for its wearable watch to include an ECG app, that can classify whether there are signs of atrial fibrillation (AFib), and another app that analyzes pulse rates for irregular rhythms.

Earlier this year, MD+DI reported that Apple was working on an FDA submission. The agency has gone on record and said Apple’s solution isn’t designed to replace "traditional methods of diagnosis or treatment.”

The response from the industry regarding the new medical apps vary and there are still many unanswered questions about the technology and the potential impact it could have on the wearable device market.

“It is exciting to see FDA working hard to foster innovation this way,” Brian Chapman, a principal with ZS, wrote in a research note. “There of course are some hurdles to be met to move from consumer product to true diagnostic medical device so these will be key going forward.”

Chapman added, “there is still some distance between a consumer device with the capability of finding a signal and a medicalized diagnostic solution that guides therapy.”

Something New or the same old Thing?

Apple’s medtech apps might have made headlines and gained a lot of attention, but there are other similar technologies out there on the market.

“From a regulatory standpoint there isn’t much new here,” Bradley Merrill Thompson, a member of the firm at Epstein Becker & Green, P.C., told MD+DI. “The actual ECG clearance is only marginally different from what AliveCor has been doing for years.”

 Last year, AliveCor obtained a nod from FDA for the KardiaBand ECG accessory. The Mountain View, CA-based company’s technology is compatible with the Apple watch. The KardiaBand is a clinical grade wearable ECG that replaces the Apple Watch band. The company said the accessory provides accurate and instant analysis for detecting AFib and normal sinus rhythm in an ECG. The company has also developed Kardiamobile, which is compatible with Android devices.

 AliveCor’s product is more robust and is more of a clinical application, but Charles Wolfus, head of digital health and technology at MyoKardia, argues that Apple’s upcoming heart monitoring apps still carry a high level of importance and could attract more consumers.

 "I do take this as a game changer, but I also recognize that different parts of the industry have a different perspective on its relative importance,” Wolfus told MD+DI. “I think it’s a game changer because this type of a tool is going to be available to millions of people at a time. This is going to help people have better discussions with their caregivers and their physicians about their bodies and their health.”

 Another company that sits firmly in the wearable ECG market space is IRhythm Technologies, which was a finalist for Medtech Company of the Year in 2016. The San Francisco-based company received FDA clearance for Zio Patch, a wearable that offers ambulatory monitoring of a patient's heart rhythm for up to 14 days, back in 2011.

 The firm gave some clarity on whether or not Apple’s technology could be looked at as competition to the Zio patch.

 “[Apple’s Apps] ha[ve] the potential to drive awareness of cardiac monitoring to the consumer population, such that any consumer who might have [AFib] detected by their watch would subsequently be encouraged to visit their physician,” iRhythm Technologies told MD+DI via email on Friday. “Those physicians will still need to prescribe Zio for these patients to fully diagnose and characterize the burden of any arrhythmias, giving us a broader reach than we have today.”

 The company added, “we’d also note that the technology [Apple’s ECG] remains relatively limited and not in any direct competition with Zio. A 30-second snippet of on-demand ECG is not sufficient to fully diagnose or characterize a patient’s ECG burden. This is essentially the same as event monitor technology which has been around for some time, but now can reach a broader group of patients.”

 Jason Mills, an analyst with Canaccord and Genuity mostly agreed with iRhythm Technologies’ assessments.

 “Ultimately, we view the addition of ECG monitoring capabilities to Apple’s new watch (along with an overall growing consumer wearable market) as a potential market expander for Zio/A-ECG devices, as wearable devices further highlight the benefit of prophylactic monitoring, helping funnel patients into physicians’ offices, which we think, over the long-term, will lead a) physicians to prescribe dedicated, continuous monitoring devices that ascertain long-term ECG data/AFib burden, thereby b) driving increasing diagnosis of AFib (among other arrhythmias and conditions), and c) potentially augmenting long-term growth in AFib ablation procedures,” Mills wrote in a research note.

 The Apple Watch Series 4 is set to hit the market on Sept. 24.

6 Products that Could Help Tackle Pain

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FDA Approves First New Device for Heart Vessel Tears in 17 Years

Biotronik FDA Approves First New Device for Heart Vessel Tears in 17 Years
Biotronik's PK Papyrus Stent System is a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated heart vessel using a balloon catheter. Once the stent is implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle.

Cardiologists have a new tool for handling a rare but potentially life-threatening complication during percutaneous coronary intervention (PCI) procedures.

FDA approved Biotronik's PK Papyrus Covered Coronary Stent System as a treatment for tears in the coronary arteries that can occur during heart vessel procedures. The PK Papyrus System is the first device FDA has approved for this indication in 17 years. The device has been CE marked for sale in Europe since 2013.

"The PK Papyrus Covered Coronary Stent System provides healthcare providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure," said Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in FDA's Center for Devices and Radiological Health.

During PCI, a thin flexible tube with a balloon on the end is inserted into a narrowed coronary artery. Once inserted, the balloon expands the artery, and then a small mesh stent is placed to hold the artery open and increase blood flow to the heart muscle. On very rare occasions, a deep tear occurs in the wall of the treated coronary artery during the PCI procedure. In some coronary perforations, blood can leak out through the tear leading to a life-threatening collection of blood in the sac surrounding the heart.

Biotronik has developed a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated coronary artery vessel using a balloon catheter, similar to the one used during the PCI procedure. Once the new stent is implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle. Successful sealing of a coronary perforation with the PK Papyrus System can be a life-saving procedure without the need for open-heart surgery, FDA noted.

The agency reviewed data for the PK Papyrus System through the humanitarian device exemption process. To qualify for a humanitarian device exemption, a device has to be intended to benefit patients by treating or diagnosing a disease or condition that affects 8,000 U.S. patients a year or fewer.

To support the approval, Biotronik submitted real-world survey data from 80 patients who received the device to treat coronary artery perforations. The stents were successfully delivered to the perforation site in 76 of the 80 patients (95%), and the stent successfully sealed the perforation in 73 patients (91.3%). Two patients died during the procedure, and seven patients had a fluid collection around their heart that had to be drained. After the procedure, six additional patients died in the hospital (five were patients whose perforations had been successfully sealed by the new stent, and one was a patient whose perforation was not successfully sealed by the device).

FDA said patients who are not considered candidates for standard PCI procedures should not be treated with the PK Papyrus System.

Hologic Heard FDA's Vaginal Rejuvenation Warning Loud and Clear

Hologic Heard FDA&#039;s Vaginal Rejuvenation Warning Loud and Clear

FDA recently began cracking down on manufacturers of laser and energy-based devices that, in some cases, have been inappropriately marketed for vaginal rejuvenation procedures. In July the agency sent "it has come to our attention" letters to several manufacturers of these devices and it seems at least one of those manufacturers got the message loud and clear.

After receiving a letter from FDA in July about its MonaLisa Touch laser device, Hologic decided to suspend the marketing and distribution of a different device, the TempSure Vitalia handpieces and single-use probes, even though the agency's letter didn't specifically mention the Vitalia product. The MonaLisa Touch, on the other hand, is still on the market. Both products are sold by Hologic's Cynosure division.

It may seem odd that the company took this action on a product that was not specifically mentioned in FDA's letter (Vitalia) while leaving the product that was the subject of the letter (MonaLisa Touch) on the market, but the decision likely was based on clinical evidence and how each device is typically used. There is much less clinical data for Vitalia than for the MonaLisa Touch, according to Mike Matson, a medtech analyst at Needham & Co. He also noted that Vitalia is typically used for "vaginal laxity" whereas the MonaLisa Touch is more often used for vaginal dryness. 

"Despite the near-term financial impact, we think that the Vitalia suspension was the right thing to do and over the longer run, this should serve to improve [Hologic's] image and brand in the aesthetics market," Matson said in a report Thursday.

This week Hologic updated investors on the anticipated financial impact of its decision to suspend the Vitalia products. The company disclosed on an SEC filing that the TempSure Vitalia system suspension could impact fourth-quarter Cynosure revenue by $15 million due to refunds. The good news for the company and investors is that strong performance in Hologic's other businesses should keep the company's fourth-quarter revenue within the previously guided range of $800 million to $815 million.

Hologic acquired Cynosure last year for about $1.65 billion. Back when that deal was first announced, Hologic CEO Steve MacMillan told investors that one of the things that attracted the company to Cynosure was that it had used business development smartly to add to its portfolio. "For example, Cynosure is the exclusive distributor for the MonaLisa Touch device, a novel CO2 laser for vaginal rejuvenation," MacMillan said.

The company just launched the TempSure Vitalia system in North America this past July, touting the advantage of the system's Therapeutic Logic Control, a time and temperature monitoring system that ensures treatment timing will begin only when the target tissue is at a therapeutic temperature. This helps deliver repeatable treatment results, the company noted.

"TempSure Vitalia responds to customers who expressed a need for a consistent and effective intimate wellness therapy that takes the guesswork out of radiofrequency treatments," said Kevin Thornal, president of the Cynosure division. "It also expands the offerings on our TempSure radiofrequency platform. We are pleased that in just six months, we were able to launch an additional handpiece while simultaneously providing a solution to patients who have experienced changes in their vaginal health over time."

Supplier Stories for the Week of September 9

This is a compilation of the latest news from suppliers in the medical device industry.If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

AngioDynamics Acquires RadiaDyne for an Undisclosed Sum

Pixabay AngioDynamics Acquires RadiaDyne for an Undisclosed Sum

It continues to be a busy week for M&A in the medtech industry. This time around AngioDynamics is making a play to acquire RadiaDyne, the developer of a radiation dose monitoring platform, for an undisclosed sum. The deal is set to close at the end of September.

This transaction expands Latham, NY-based AngioDynamics’ growing Oncology business by adding RadiaDyne’s early-stage, OARtrac real-time radiation dose monitoring platform and other market-leading oncology solutions, including the IsoLoc/ImmobiLoc and Alatus balloon stabilizing technologies.

The acquisition follows AngioDynamics’ acquisition of the BioSentry Tract Sealant System from Surgical Specialties for an undisclosed amount in August.

“The acquisition of RadiaDyne, combined with our recent BioSentry asset purchase, delivers on our commitment to build a world-class oncology portfolio,” Jim Clemmer, president and CEO of AngioDynamics said in a release. “We believe that together, these disruptive, patient-focused technologies will deliver safer, clinically-relevant, economically-favorable solutions for patients. This combination will significantly expand our value proposition and meaningfully change how care is delivered.”

During a July earnings call, AngioDynamics CEO Jim Clemmer assured investors the company was able to execute M&A opportunities either in terms of acquisitions or divestitures.

“As we have discussed in recent quarters, one of our top strategic priorities has been portfolio optimization both internally and through value creating M&A,” Clemmer said, according to a transcript from Seeking Alpha. “Our portfolio optimization will focus on the continuum of care within oncology as well as disruptive and patient focused technologies that are differentiated and truly changing healthcare has delivered. We will continue to seek out acquisitions focused on products and technologies that fulfill unmet needs in large addressable markets and generally have high margin profiles.”

AirXpanders Is Pumped for Anticipated Growth After Recent Financing

AirXpanders Inc. AirXpanders Is Pumped for Anticipated Growth After Recent Financing

The company responsible for the first major change in breast tissue expansion in almost 40 years is getting strong support from investors.

San Jose, CA-based AirXpanders recently closed a rights offering in Australia to raise roughly A$15.7 million, along with a U.S. placement to raise about $3.4 million (A$4.6 million), equivalent to a total of about $15 million before transaction costs. Vivo Ventures invested $3.3 million of the U.S. placement and the company's board chairman invested $500,000.

"We are confident of the outlook for the company and the successful closing of our A$20.3 million raising places us in a sound financial position to deliver on our anticipated growth over the coming year," said Frank Grillo, the company's president and CEO.

AirXpanders, which is on the Australian Securities Exchange, developed the AeroForm Tissue Expander System. As MD+DI reported last year, FDA has granted de novo clearance to the device. The AeroForm is a  needle-free, patient-controlled, wireless, tissue expander system for women who choose to have reconstructive surgery following a mastectomy. The device was a gold winner in the 2018 Medical Design Excellence Awards in the category of implant and tissue-replacement products, and also won the award for best in show.

The device has an interesting backstory, as it was inspired by a flat tire. Daniel Jacobs, a plastic surgeon in San Jose, CA, pulled out a carbon dioxide cartridge to fill a bicycle tire and began to wonder if he could use the same technology in a breast tissue expander. 

Following a mastectomy, the AeroForm tissue expander is placed underneath the chest muscle to enable the chest wall to be stretched to make room for a permanent breast implant. The device contains a reservoir of compressed carbon dioxide. Using a hand-held, wireless dose controller, the patient can release 10cc of CO2, up to three times a day, to gradually inflate the expander. This can be done from home or work, and only takes a few seconds, according to the company.

It's an alternative to the traditional method of saline-based tissue expansion, which requires multiple medical office visits and can be painful. Each injection of saline, which can be up to 60 cc, may be painful because it stretches the skin so much, Jeffrey Ascherman, MD, of the Columbia University Department of Surgery, told MD+DI in a 2016 interview. Ascherman was the principal investigator in the company's XPAND trial.

Apple Gains FDA Clearance for ECG App for Apple Watch Series 4

Apple Gains FDA Clearance for ECG App for Apple Watch Series 4
Image source: Apple Inc.

Apple Watch Series 4 will feature two new medical apps marketed with FDA’s blessing, thanks to De Novo classifications. The new watch will offer an ECG app, a software-only mobile medical application that can classify whether there are signs of atrial fibrillation (AFib), and another software-only mobile medical app analyzing pulse rates for irregular rhythms. (Neither is intended to replace "traditional methods of diagnosis or treatment," FDA stated in the notices.) These features are scheduled to be available in the United States later this year, Apple COO Jeff Williams said during the company’s September 12 launch event.

And, with a next-generation accelerometer and gyroscope, Series 4 can now detect falls to alert consumers and summon emergency services if needed.

These features (along with enhanced design, aesthetics, and other consumer conveniences) can allow consumers to create what Williams called “the ultimate health and fitness watch.” 

Apple Watch has offered an “optical heart sensor” from its beginnings, he said, but “we wanted to do even more in this space, so we are launching three new heart features.” Powered by that optical heart sensor, Apple Watch Series 4 will be able to detect and notify users of a low heart rate and of an irregular heart rhythm. A new electrical heart sensor uses new electrodes added to the watch’s back crystal and digital crown to allow consumers to take an electrocardiogram (ECG).

“The entire process takes just 30 seconds, and at the completion of the ECG recording, you will receive a heart rhythm classification,” Williams said. All ECG recordings, their classifications, noted symptoms are stored and can be shared with a doctor, he added, calling the built-in electrical heart sensor an “industry first.”

For detecting falls, the next-gen accelerometer and gyroscope feature “twice the dynamic range, measuring up to 32 g-forces, and can sample motion data 8 times faster,” he said. The technology allows Apple “to do something new. One of the leading causes of injuries worldwide is falls . . . . now Apple Watch Series 4 can detect a fall,” he said. Apple conducted studies with thousands of consumers to better understand motion patterns and more to develop the fall-detection capabilities.

Apple Watch Series 4 “is the ultimate guardian for your health, the best fitness companion, and the most convenient way to stay connected,” Williams said.

FDA weighed in on the advances the same day, issuing a joint statement on “agency efforts to work with tech industry to spur innovation in digital health” from FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren. “Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients,” they wrote. “With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch.”

The agency worked with Apple during software development and testing, added Gottlieb and Shuren.

Earlier this year MD+DI reported that Apple was working on an FDA submission.