Saudi regulators revise medical device shipment requirements

By Stewart Eisenhart, Emergo Group

The Saudi Food and Drug Authority (SFDA) has published revised requirements for clearing imported medical devices at Saudi ports of entry.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Integer closes $600m sale of advanced surgical, ortho lines to MedPlast

Integer (NYSE:ITGR) completed the spinoff of its advanced surgical and orthopedics products lines to MedPlast for $600 million in cash. Announced in May, the deal will double MedPlast’s top line and bolster the balance sheet for Integer, which missed expectations with its first-quarter earnings.

Integer said it will apply the proceeds to reduce debt by about $550 million, which will include redeeming its 9.125% senior notes, paying off the balance of its revolving credit line and prepaying Term B loans. The company expects the divestiture will boost share prices because the lower interest expense from the debt reduction will more than offset the net income being divested, it said in a statement.

The deal does not include Frisco, Texas-based Integer’s portable medical line, the companies said previously. Integer said it will elaborate on the financial impact of the deal in its second-quarter results on Aug. 2.

“We believe this action has already created significant value for Integer shareholders and positions us to even more aggressively execute on our strategy,” said Integer CEO Joe Dziedzic in the statement. “Our operational strategy, comprised of six strategic imperatives focused on customers, costs and culture, is a multi-year roadmap to achieving excellence in everything we do.”

The divestiture leaves Integer a $1.2 billion company with higher margins, increased earnings, greater returns on invested capital, and significantly lower debt leverage, according to Dziedzic. ” We are executing our strategy to drive accelerated long-term growth and realize our vision of enhancing patients’ lives and earning a valuation premium for our shareholders,” he said.

It’s the third buyout in two years for privately held MedPlast, which bought Vention’s medical device manufacturing services division in March 2017 for an undisclosed amount and acquired medical device assembler Coastal Life Technologies three months later. The Tempe, Ariz.-based company has said its sales will near the $1 billion mark after the deal, which will also expand its footprint in Europe.

Integer’s stock closed yesterday at $65.80, up from $40.01 one year ago.

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CEL-SCI wins $2.9M in CRO legal battle

Score one for the little guy.

After a four-year legal battle, immunotherapy maker CEL-SCI Corporation has won the first-ever breach-of-contract case against a contract research organization, or CRO.

In a final and binding decision, an arbitrator concluded that CRO inVentiv knowingly and fraudulently misled CEL-SCI with regard to enrollment projections for a clinical trial of CEL-SCI’s immunotherapy treatment for head and neck cancer. The arbitrator also said inVentiv used “scorched earth” litigation tactics and awarded CEL-SCI $2.9 million in damages, according to a statement from Vienna, Va.-based CEL-SCI.

The arbitrator denied inVentiv all but one of its counterclaims against CEL-SCI, which was for $429,649 for certain unpaid invoices.

Get the full story on our sister site, Medical Design & Outsourcing.

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HeartFlow wins UnitedHealthcare coverage for FFRct analysis

HeartFlow said today that it won reimbursement coverage from insurer UnitedHealthcare, which will now cover its HeartFlow FFRct fractional flow reserve analysis for its 45 million members.

HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

The Redwood City, Calif.-based company touted that with the new coverage, its HeartFlow FFRct is available to 235 million individuals in the US.

“This decision by UnitedHealthcare underscores the significant value that the HeartFlow Analysis brings to payers, physicians and patients, from both a clinical and economic standpoint. Not only is the HeartFlow Analysis now accessible to tens of millions of additional people, but this advancement also positions HeartFlow as an integral part of the standard approach to heart disease diagnosis and treatment,” prez & CEO Dr. John Stevens said in a press release.

The company said that UnitedHealthcare also adopted a policy which allows for the use of coronary CTA as a first-line test for symptomatic individuals, and that its FFRct analysis is approved to further assess coronary disease seen on a coronary CTA.

In March, HeartFlow said it inked a collaborative research agreement deal with the Imperial College London for research in the areas of medical imaging and deep learning using the company’s FFRct technology.

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Can placental tissue implants limit back and leg pain?

Regenerative technology company StimLabs has enrolled the first patient in a clinical trial using shelf-stable placental tissue to reduce complications following herniated disc surgery.

The multi-center, randomized controlled trial will evaluate the safety and efficacy of Revita, StimLabs’ full-thickness placental allograft, which surgeons will place following lumbar microdiscectomy procedures. Microdiscectomy is a common, minimally invasive procedure to remove the herniated or protruding portion of the intervertebral disc that is compressing the traversing spinal nerve root. Common post-surgical complications include scar tissue formation and reherniation.

Get the full story on our sister site, Medical Design & Outsourcing.

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New clinical study personnel: How to manage the changes at your site

Melissa Wollerman, Clinical Research Associate, IMARC

As many of us monitors are aware, there is high turnover in the research industry and clinical sites aren’t exempt from this. Quite often, we are likely to receive an e-mail with very little information regarding the current study coordinator or other study personnel leaving a clinical site. We may possibly receive a sentence that consists of who will be taking their place, or perhaps no notification at all.

How do you go about handling the notification, or lack of notification?

  1. Stay calm. If a monitor has received many of these e-mails before, they know that this can be frustrating; having to train yet another coordinator or investigator that may not be with the site for very long. It’s important to keep your composure and respond to that e-mail expressing gratitude for the notification and for their time and efforts on the study.
  2. Keep in contact. A great way to avoid silence from the site is to often keep in contact with them. A consistent relationship can go a long way, and simply having a personable attitude will make the transition a lot smoother.
  3. Understand the site. Perhaps the site is one that rotates fellows every 6-7 months or has an intern that may only be on the study for the summer. Get to know the site at the first visit so that you can be prepared for these changes.
  4. Inform applicable personnel. The notification from the site may have only been sent to the monitor and no other team members. It’s important to also ensure that all appropriate study team personnel are aware of the change. A simple e-mail to the Sponsor and other members of the study team will ensure that everyone is notified and up-to-date with the personnel changes and can fast-track the training process.
  5. Properly train the new study member. It can be frustrating for the new study personnel who may be walking into a study that is unorganized with little hand-off training by the previous personnel at the site.   Also, being brand new to the study and not knowing the process and expectations can be challenging. Ensure that enough time is devoted to training the new member so that they feel comfortable with the study, possibly resulting in a stronger relationship with the monitor.

When you receive that e-mail from the site notifying you that there will be a change in contact, glance over the points above and think about how you can efficiently conduct the onboarding process to ensure you are prepared for this change and future changes.

Have you experienced high turnover at your sites? How did you proceed with the information you were given regarding the new study personnel? How can you make this process better and more efficient?

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Obalon touts gas-filled gastric balloon after FDA notice of deaths related to liquid-filled balloons

Obalon Therapeutics (NSDQ:OBLN) today touted that it has never received a report of a death related to the use of its Obalon six-month gas-filled gastric balloon system designed to aid in weight loss in light of a recent FDA notice warning of five deaths related to liquid-filled gastric balloon systems.

The San Diego-based company clarified that the FDA notice released earlier this week, which mentioned deaths related to the use of both Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS) liquid-filled gastric balloon devices, did not apply to its gas-filled balloons.

“Our first concern is for the patients and families, as well as the health care professionals that care for these patients, who are impacted by these adverse events.  Patient outcomes, especially safety, has always been the highest priority at Obalon. We believe we have a novel product that is performing very differently than the liquid-filled balloons and a team of people at Obalon who are responsibly and ethically building this important new therapy category for the treatment of obesity,” prez & CEO Andy Rasdal said in a press release.

Obalon touted its efforts to track adverse events related to the Obalon balloon system, and said that it will continue to track any issues with the system and will appropriately report them to the FDA and other regulatory bodies.

“Obalon has always believed that obesity is a serious chronic disease, which if left untreated, is the gateway to the progression of more serious health events, such as diabetes and cardiovascular disease. Based on the data collected in the Obalon Commercial Registry, as well as the low number of reported events, we believe the Obalon Gas-Filled Balloon is performing with the same strong safety profile as it did in our Pivotal Trial and provides an important treatment option for obese patients who cannot lose weight with diet and exercise alone,” regulatory affairs VP Amy VandenBerg said in a prepared statement.

In March, Obalon saw shares fall after posting fourth-quarter and full-year results that failed to meet both its own expectations and the consensus forecast on Wall Street.

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7 MD&M East exhibitors you need to know

MD&M East is a major medtech tradeshow on the East Coast of the U.S., showcasing some of the industry’s latest developments in packaging, automation, plastics, design engineering and quality.

The event houses over 750 suppliers with more than 8,000 attendees who are able to network, explore new career opportunities and find partners for projects.

The event will take place at the Jacob K. Javits Convention Center in New York, June 12–14.

Here are seven exhibitors you should check out at MD&M East this year.

Next >>

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Comparing drug and medical device clinical trials

Understanding the similarities and appreciating the differences between drug and medical device clinical trials is important for every trial participant—from the patients to the researchers. Whether the product being investigated is a drug or device, a well-organized, efficient clinical trial can save time and money for each individual and organization involved. Additionally, the faster and more accurately a trial is performed, the faster the new medication or clinical product can be introduced to the market and begins helping the community.

So, while the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the game goal:  to safeguard those research participants while bringing safe and effective products to the market as quickly as possible.

Please take time to download IMARC’s “Comparing Drugs & Devices: How are the Clinical Trials Regulated?”

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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FDA takes cautious approach to new regulations for OEM and third-party device servicers

By Joel Domanowski, Emergo Group

The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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