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Articles from 2019 In February

Loose tea brews up recyclable barrier pouches

Loose tea brews up recyclable barrier pouches
Created by a collaboration among three firms, Harney & Sons new flexible pouch is 100% recyclable while still meeting the brand’s criteria for moisture and oxygen protection, performance and aesthetics.

Tea producer Harney & Sons has introduced multilayer stand-up pouches for its loose-leaf and herbal-infusion products that are a first for the category. Created by TC Transcontinental Packaging in collaboration with Dow Chemical and Charter NEX Films, the pouches feature an ethylene vinyl alcohol (EVOH) barrier and reportedly are 100% recyclable.

Emeric Harney, marketing director for Harney & Sons, says packaging sustainability is a priority for the company.

“Our company is a member of 1% For the Planet, an organization that assists us in donating 1% of our gross profits to non-profits,” he says. “Additionally, as a forward-thinking company and an innovator, we are trying to push the envelope where the packaging industry and the tea industry overlap. For many years, there wasn't a lot of available technology to change elements of our packaging. But now there is.”

Rebecca Casey, vp, marketing and consumer market development, TC Transcontinental Packaging, says while pouches have popped up bearing claims of full recyclability, the new Harney & Sons pouch stands out.

“The pouch is a multilayer barrier stand-up pouch, 100% recycle ready for in-store drop off,” she says. “A multilayer, flexible barrier film was not currently commercialized for a food product. A multilayer, coextruded film is essential to preserve the delicate flavor of tea by protecting the product’s natural oils that give tea leaves a smooth flavor and finish.”

Casey adds that while food-product pouches tend to contain polyethylene (PE) to guard against moisture and EVOH to block gases, the combination made recycling the packages impossible. “We developed one of the first commercialized packages for food that hits all notes: 100% recycle ready for in-store drop off, EVOH barrier for product preservation, seal strength and durability,” she says.

The pouches’ recyclability is made possible by Dow Chemical’s proprietary Retain resin technology. The technology compatibilizes the barrier, allowing the multilayer film to be recycled. Charter NEX provided its GreenArrow recyclable films. The two companies and TC Transcontinental Packaging collaborated on extruding, laminating and converting the materials to create a 100% recyclable barrier pouch.

According to Casey, coming up with a pouch that met the brand owner’s standards for product protection, flavor and aroma preservation and looks—all while being fully recyclable—presented a list of challenges.

“There is a smaller operating window for sealing, varying both the temperature and speed—too much heat can distort the seal profile, and too little heat can lead to possible leakers, most commonly found in the zipper and gusset crush area as discovered through our testing process,” Casey says. “Transcontinental Flexstar has put in place procedures, equipment and know-how to produce this in-store drop off fully recyclable pouch.”

The films are converted into premade pouches at Transcontinental Flexstar. Each pouch features a Presto Fresh-Lock zipper, made of PE to meet requirements for in-store drop-off recycling.

Harney & Sons launched the recyclable pouches in its stores in November. Harney says as the pilot continues, employees will continue to educate customers on the pouches’ innovative recyclable structure.


Jenni Spinner

Freelance writer and former Packaging Digest senior editor Jenni Spinner is a trade journalist with more than two decades of experience in the field. While she has covered numerous industries (including construction, engineering, building security, food production and public works), packaging remains her favorite.


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What can you learn from great packaging designs and concepts?

Photos supplied by brand owners New packages introduced in 2018

Where do you get ideas for new packaging designs? For the third year in a row, you can search through a free database of new packages posted on Packaging Digest over a full year. Packaging professionals looking for design ideas can review nearly 200 items posted in 2018 from more than a dozen different markets.

The database is designed for easy scanning yet provides a link to each article so you can get all the details you want. Short summaries succinctly explain what is most compelling about the package. Color photos and captions showcase and describe critical details.

Learn from major brand owners like PepsiCo, Chobani, Medtronic, GlaxoSmithKline and Procter & Gamble, as well as from entrepreneurs taking daring steps in high-growth markets like Cannabis, Beverage and Toys.

Copies of identical databases from 2017 and 2016 are also still available for free downloads:

2017: “166 new packages to inspire you”

2016: “2016 parade of new packages showcases great design”



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So, When is the GE Healthcare IPO Happening?

Don’t look for General Electric to spin out its healthcare unit just yet. The Boston, MA-based company said an IPO for its healthcare business was going to be put on hold while it sells of its pharmaceutical unit to Danaher for $21 billion.

During an interview with CNBC, General Electric’s chairman and CEO said that an IPO of for GE Healthcare in 2019 is “unlikely at this point.”

The firm made waves in June of 2018, when it announced it would spin out GE Healthcare. During that time, the company said the IPO could occur sometime this year. The reason behind the move was it would give the company a chance to get back to its roots and focus on aviation, power, and renewable energy.

General Electric’s plans called for it to sell about 20% of the health business and spin off the rest to its shareholders. The healthcare unit has long been a bright spot for General Electric. In 2018, GE Healthcare generated about $19 billion in revenue with $3.4 billion in profit.

General Electric isn’t the only company that has been in the process of restructuring and divesting businesses. Shortly after the company announced the healthcare spin out, Bovie Medical revealed a plan to sell its electrosurgical offerings to Specialty Surgical Instrumentation, a subsidiary of Symmetry Surgical, for $97 million.

Johnson & Johnson has been very active in shedding off units in the past few years.

In early 2017, the New Brunswick, NJ-based company made a huge splash when it was announced it was selling its Codman Neurosurgery Business to Integra Lifesciences for $1.05 billion. J&J had then announced plans to shut down Animas Corp., which once provided insulin pumps to 90,000 patients. J&J said those insulin pump users would have the option to transfer over to Medtronic pumps.

The company capped off its divestitures by selling off its LifeScan Diabetes unit to Platinum Equity for $2.1 billion.

Medtronic Keeps DES Market Hot with New Indication

Rumblings in the Drug-Eluting Stent market continued this week after Medtronic said it has obtained FDA approval for an additional indication for its Resolute DES platform and the Resolute Integrity.

The Dublin-based company’s new indication is for the treatment of patients with coronary disease who have de novo chronic total occlusion (CTO), a complex vessel condition involving complete blockage of a coronary artery. CTO is considered more difficult to treat with percutaneous coronary intervention (PCI) due to a greater risk of complications.

The expanded CTO indication was supported by data from the PERSPECTIVE Study, a single-center, observational study of 183 CTO patients who underwent a stent procedure with the older-generation Resolute IntegrityDES. Results showed that patients treated with the Resolute DES exhibited low rates of repeat revascularization (1.1%), cardiac death (2.2%) and minimal stent thrombosis (0.6%) at one year.

"This expanded indication will allow physicians the option to treat these more complex CTO cases with the Resolute Onyx DES, which has shown strong clinical performance across a variety of vessel sizes and anatomies," Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, said in a release.

Approved in the U.S. in 2017 following Resolute Integrity DES, the newest-generation Resolute Onyx is the first and only DES to feature Core Wire Technology, a unique Medtronic method of stent manufacturing that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent.

News of the expanded indication comes on the heels of Biotronik receiving approval for its DES system.

How Endologix Is Winning Customers Back One Procedure at a Time

Endologix might not be out of the woods yet, but the company does appear to be moving in the right direction.

"We are shifting from a defensive position to an offensive position," CEO John Onopchenko said during the company's fourth-quarter earnings call on Monday, as transcribed by Seeking Alpha.

The company reported sequential sales growth of its Ovation system in the fourth quarter, which management said gives them confidence that the platform will return Endologix to growth in the second half of 2019.

But to fully appreciate that projection, investors have to look back at where the Irvine, CA-based company was just two years ago.

The company's revenue dropped 6.1% in the fiscal year 2017 compared to the fiscal year 2016 after a manufacturing glitch interrupted sales of its top-selling device for abdominal aortic aneurysms (AAA), the AFX. This and other issues led to former CEO John McDermott's resignation last year. Onopchenko was promoted to fill the CEO seat in July.

Another setback came earlier this year when Endologix initiated a voluntary recall of the existing inventory of its Nellix endovascular aneurysm sealing system. The company decided to limit the device to use under clinical protocol with pre-screened patients that adhere to the current indications. The company's CE mark for the Nellix system was subsequently suspended.

During the earnings call, Onopchenko stressed that the suspended CE mark will have minimal impact on the company's U.S.-based Nellix trials. Clinicians will continue to treat patients under investigational umbrellas, including the EVAS2 IDE, he said. Enrollment in that trial is expected to wrap up in the third quarter of this year.

As for the company's AFX2 business, CFO Vaseem Mahboob said he expects AFX2 sales to stabilize in the second half of the year as Ovation sales continue to grow and return the company back to growth in the second half.

"The return to growth, that road begins with AFX2 stability," Onopchenko said. "We've been invited back to cases where customers had previously discontinued the use of AFX2 over type III endoleaks. And upon being invited back, they've specifically commented that having data from our LEOPARD RCT gives them the confidence that we've addressed the issues."

Onopchenko also noted that the company has received feedback that the procedural safety and device performance demonstrated in LEOPARD matches what physicians have seen in their own practice with AFX2. 

"That, in combination with renewed confidence and positive prior experiences, that's starting to allow us to win back a number of customers, and it's opened the door with others," Onopchenko said.

On the Ovation side, Onopchenko said he recently participated in a key account visit with a tertiary care teaching institution which had two physicians use the Ovation once last year.

"They get to understand not only who we are and our strategy and plans but take a deeper dive in terms of how we produce the product, how we ensure the safety of that product," Onopchenko said.

Visits like that also give Endologix an opportunity to correct misperceptions that some customers might have about the products.

"And in that particular case, I'm pleased to say that in the month of February, we've already done two cases with a total of five cases planned in that one account," Onopchenko said. "Not all of them go this way, but ... this campaign upmarket is kind of [one] account at a time and brick by brick, but we're making real progress."

Alphatec Brings Home 510(k) for Neuromonitoring System

Alphatec Holdings has received 510(k) clearance FDA for its automated SafeOp neuromonitoring system for use in real-time intraoperative nerve location and health assessment.

The Carlsbad, CA-based company said the next-generation technology of the SafeOp system represents a “significant advancement” in two intraoperative neurophysiological monitoring (IONM) modalities: somatosensory evoked potential (SSEP), and electromyography (EMG). SSEP assesses the functional health of the spinal cord and nerves, while EMG enables surgeons to test nerves for their location, proximity, and conduction. The SafeOp automated SSEP technology has been successfully used in more than 1,000 surgeries to identify potential nerve injury from patient positioning, and has demonstrated reliability in monitoring peripheral nerves in spine surgery. The current 510k clearance expands the system to include more advanced algorithms for EMG.

The SafeOp system’s initial focus will be on resolving the significant unmet clinical need in minimally invasive lateral procedures, but it can and will be leveraged into multiple Alphatec surgical approaches.

Alphatec said it expects full commercial launch of the SafeOp system in Spring 2019. It is the first solution delivered as part of the Alpha Informatix platform, which the company plans to expand to provide surgeons with intraoperative information beyond neuromonitoring.

Do You Consider the Recyclability of Your Packaging?

When medical device packaging engineers research customer needs during “voice of the customer” studies, they don’t necessarily ask, “How’s this package going to be disposed of?” explains Nicholas Packet, a packaging engineer and MDM specialist for DuPont. But he’d like that to change.

“My hope is that engineers start to consider the recyclability of their flexible packaging designs and materials,” he told MD+DI. “This may not be the top priority on new products, but as part of their sustaining engineering projects, I hope it encourages them to evaluate their packaging materials, consider its recyclability, and impact the materials may have on the consistency of the waste stream.”

Packet will be speaking about medical packaging recycling during the upcoming HealthPack presentation, “Flexible Packaging Material: Challenges and Opportunities for Recycling.” He and co-speaker Tristan Steichen, project manager for the Healthcare Plastics Recycling Council, will share the results of a study on flexible plastic packaging materials conducted by HPRC and the University of Massachusetts–Lowell.

Packet said there does “seem to be more efforts and activities taking place at healthcare facilities, hospitals, and MDMs to recycle their healthcare plastics. I think this is being driven by a number of factors—awareness, disposal costs, and organizations simply wanting to find another place for this plastic waste than the landfill. I think people are starting to recognize that healthcare plastics, many of which are virgin materials, can have value in a secondary life.”

But as expected, end-of-life considerations such as recycling and disposal aren’t the first considerations for packaging engineers. “Medical device packaging engineers face a number of different requirement and expectations for their package design. Maintaining the products’ protection, sterile integrity, and product use rise to the top of the list,” said Packet. “I think one of the challenges is how engineers can account for a requirement that helps facilitate the recyclability of their packaging and balance this with their other requirements so it doesn’t fall to the bottom of the list.”

Package optimization has been an ongoing trend for some time. “Engineers are continuing to drive package size reductions, material consolidation, and the redesign of old packages that may be inefficient or use undesirable or materials of concern,” said Packet.

But engineers are also pretty conservative when it comes to material selection. “Packaging engineers working in new product development tend to be more risk adverse, so they gravitate to existing materials that have a proven track record and passed previous validations,” he said.

HPRC does offer suggestions for engineers with its “Design Guidance: Best Practices for Recyclable Products and Packaging.” It’s hard to say how much of an impact such guidance has had, but Packet says that “the council, often through our healthcare advisory board members, bring insights and awareness to things that are not being considered when it comes to the selection and use of plastic packaging materials.”

The study results Packet and Steichen will share at HealthPack could offer further insight. “Engineers probably make assumptions based on their own consumer experiences and how we go about disposing the plastic waste we generate, which in many cases is that rigid plastics can be recycled but flexible packaging like shopping and bread bags can’t go into your municipal recycling stream,” Packet said. “I feel this same notion holds true with how they expect and is often the reality of how hospitals handle medical packaging waste. Rigid trays are more likely to be recycled if there is a collection process set up, but flexible packages are not accepted and go to the landfill or incineration because many recyclers don’t accept flexible materials.

“This is where I see the importance and impact that the flexible packaging recycling study will have on the industry,” he continued. “Until this point, we didn’t really have a sound set of data or experience recycling these flexible and mixed materials. The study with UPENN in 2014 was a great initial set of data and now with the UMASS study completed we have a good idea on how the material will process, what its attributes will be as a second life material, and what some of the challenges will be.”

Packet said that “one of the most interesting parts of this study is the work and collaborative efforts that went into the collection process of accumulating the material for this study. I think packaging engineers are always interested in their end-use customers, and the work that was done with our healthcare advisory board and hospitals that participated in the study will bring some unique insights.”

He didn’t want to give too much away before the presentation, but he did say that researchers “didn’t see significant issues with material impurities, but flexible packages are often made up of multiple materials and multilayer films, which present some unpredictability in terms of material consistency entering the waste stream. I realize this isn’t going to be solved overnight and will always be a challenge with flexible packaging, but if engineers work to develop packages that are made of homogeneous materials, it will bring more consistency and potential value to this second life material stream.”

HealthPack attendees will also be given a “glimpse at what different types of packaging makes up the flexible waste stream and see some state-of-the-art recycling equipment,” he added. “And if you’re technical and like data, we’ll share the performance characteristics of the recycled material.”

Packet hopes the presentation will also get engineers “to start thinking about the circular economy. These [recycled] materials would not be used for product-contacting primary packaging, but I hope it inspires them to think about these second-life materials and where they may able to be used in their process or operations. Finding end-use applications is one of the keys to the success of the healthcare plastic flexible packaging recycling stream.”

6 Emerging Cardiology Solutions in Late-Stage Research at Georgia Tech and Emory University

Biotronik Has a New DES Added to its Repertoire

FDA has just signed off on Biotronik’s Orsiro drug-eluting stent (System). The Lake Oswego, OR-based company claims the stent is the first and ultrathin DES to outperform Abbott Laboratories’, Xience stent, which is known as the clinical standard.

Biotronik said its first implants will occur this week and that it will be available in health systems in the early part of this year. The company has had CE mark for Orsiro since 2011.

Perhaps the biggest selling point of the technology is the ultrathin strut design.

“Thinner struts are different in that they potentially create less disruptive flow in the arteries,” Amy Culley, Biotronik Director of VI Clinical Studies, told MD+DI. “That equates to less internal injury and improved endothelialization. This is important in reducing the risk of restenosis and thrombosis, both outcomes that we want to avoid in our patient population.”

Orsiro and Xience’s effectiveness were compared in the BIOFLOW-V pivotal trial. Biotronik’s Orsiro stent demonstrated significantly lower rates for target lesion failure and target vessel myocardial infarction at 12 months in comparison to Xience. The study looked at about 1,344 patients.

At two years, treatment with Orsiro further improved event rates in comparison to Xience, including a significant reduction in target lesion revascularization (TLR) and spontaneous MI. The two-year-results were presented at TCT 2018 and published in the Journal of the American College of Cardiologyshow a 37% lower TLF rate in favor of Orsiro (7.5% vs. 11.9% TLF rate, p-value=0.015), a 47% lower ischemia-driven TLR rate, and a 70% lower rate of spontaneous MI (landmark analysis 31 days to two years follow-up).

“I think the 2-year data unequivocally demonstrated the ability of Orsiro to secure low event rates [in] TLR, Target Vessel MI, and definitely differences that are meaningful for patients,” Culley said.

The news comes on the heels of Biotronik becoming the exclusive US distributor for InfoBionic's MoMe Kardia external cardiac diagnostic monitor. MoMe is designed to increase early detection and diagnosis of cardiac arrhythmias by providing physicians with the ability to access near real-time electrocardiographic data.

Abbott has also been keeping busy with its Xience family of stents. In April of 2018, the company initiated the ILUMIEN IV trial, to evaluate the long-term outcomes of patients who undergo stent implantation guided by optical coherence tomography (OCT) when compared to angiography. Abbott said up to 3,650 patients will be evaluated and will be randomized to either OCT-guided or traditional angiography to guide placement of one or more Xience everolimus-eluting coronary stents.