More device shortages pegged to sterilization plant shutdown

Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health)

More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant.

Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned.

The letter from Cardinal Health (Dublin, Ohio) said that the company expects a shortage of its Kendall Accu-Trace intrauterine pressure catheter until early August. This device is placed inside a pregnant woman’s uterus to monitor uterine contractions during labor. The letter from Guerbet (Villepinte, France) said that disposable power injectors used with its Optistar, Optivantage and Illumena contrast delivery systems may experience shortages. Officials from those companies did not immediately respond to requests for comment.

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Medtronic taps Lennon as CIO | Personnel Moves – April 9, 2018

Medtronic CIO Sean Lennon

Medtronic (NYSE:MDT) said that it named Sean Lennon as its new chief information officer, set to take effect April 29.

The Fridley, Minn.-based medtech giant said that Lennon will take over for Mike Hedges, who is retiring from the position after 19 years with Medtronic, including 10 as CIO.

Prior to joining Medtronic, Lennon served as CIO with Allergan (NYSE: AGN), the company said. He has previously held senior leadership positions with pharmaceutical companies including Watson/Actavis, Novartis (NYSE:NVS) and Schering-Plough.

 Clearside Biomedical appoints Lasezkay as interim CEO

Clearside Biomedical (NSDQ:CLSD) said yesterday that it named George Lasezkay as its new interim CEO, effective immediately.

Lasezkay will succeed Daniel White, who resigned as prez, CEO and as a board member to pursue other opportunities, the Alpharetta, Ga.-based company said.

Prior to joining Clearside, Lasezkay acted as exec VP and GC for novel ophthalmic therapeutics maker Acucela and as prez of Horizon Pharma Group. He has also acted as corporate dev corp VP for Allergan, the company said.

“We believe there is tremendous potential in our proprietary suprachoroidal space injection platform, as evidenced by the acceptance of our new drug application for Xipere for suprachoroidal injection. We want to thank Daniel for his visionary contributions, including licensing the original scientific technology, building our versatile therapeutic platform, leading our IPO and other financings, and hiring an experienced team to bring these important innovative products to market. We are at an important stage in the evolution of our company, so we are pleased to have Dr. George Lasezkayserve as CEO on an interim basis as we conduct a search for our next CEO. George has broad expertise in ophthalmology established during his tenure at Allergan, Inc., where he served on the company’s executive committee. With proven management experience and substantial industry knowledge, we believe George will help lead our team as we prepare for commercialization of our first product and look to leverage our unique platform through pipeline expansion and partnerships. We expect to benefit from his combination of clinical, legal, business development and executive expertise, and his diverse experience working with a number of emerging biopharmaceutical companies,” board chair William Humphries said in a press release.

Clearside Biomedical said that it is initiating a search for a permanent replacement.

“We are excited about our suprachoroidal drug delivery platform and potential approval of our first agent for the treatment of macular edema associated with uveitis, which would be a significant milestone for Clearside. We also believe the platform has broad applicability in other eye diseases and continue to explore utilizing suprachoroidal administration with other small molecules and gene therapy. I am confident in the capabilities of the Clearside team and look forward to working with them to ensure the long-term success of Xipere, prudently build our ophthalmic pipeline, and work with potential partners to leverage our platform and provide international reach,” Lasezkay said in a prepared statement.

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 SynCardia Systems promotes COO Webber to CEO

SynCardia Systems said last week that it promoted current chief operating officer Don Webber to CEO, and that it tapped Peter Spadaro as its new prez & CCO.

Prior to joining Syncardia last year as COO, Webber served as COO at OptiScan and held a manufacturing operations VP position with C.R. Bard, an operations VP position with Ekos and as prez & CEO of Mitralign, Tuscon, Ariz.-based SynCardia said.

Before taking the position with SynCardia, Spadaro held a position as cardiac surgery senior sales director at Medtronic, after having spent nearly 30 years with St. Jude Medical, the company said in a press release.

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 iHear Medical names Shennib as CEO

iHear Medical said last week that it named founder & board chair Adnan Shennib as its new CEO.

The San Leandro, Calif.-based company said that Shennib had spent more than 30 years of experience in founding and leading hearing tech companies, including ReSound and InSound Medical.

iHear Medical also said that Varun Bhardwaj joined the company as operations VP, having previously held the position of chief innovation officer.

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 LumeNXT names co-founder Rhyne as CEO

Surgical device maker LumeNXT said last week that it named co-founder Paul Rhyne as its new CEO.

Prior to co-founding Boston-based LumeNXT, Rhyne spent time with Intarcia Therapeutics, the company said. Rhyne also spent 11 years at Coloplast Corp., holding positions including Canadian country manager.

“We are proud to name Paul as CEO here at LumeNXT. His wealth of experience and insight into the interaction between the commercial business sector and healthcare space is valuable during this growth stage in our company,” board chair Marc Beer said in a press release.

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Mick Jagger is giving TAVR a boost: Here’s how

Mick Jagger TAVR

Mick Jagger during a concert in Warsaw, Poland in 2018 [Image by Jerzy Bednarski – Own work, CC BY-SA 4.0]

A successful transcatheter aortic valve replacement (TAVR) recovery for rock icon Mick Jagger could be good news for companies such as Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) that make devices for the procedure, according to analysts following the medical device industry.

The Rolling Stone frontman tweeted Friday that he was feeling better and on the mend after undergoing the procedure at a New York hospital.

“We think Mick Jagger’s TAVR procedure will likely raise awareness of aortic stenosis and potentially lead to more TAVR procedures which should benefit the TAVR manufacturers,” Wells Fargo analysts Larry Biegelsen, Lei Huang, Adam C. Maeder, Shagun Singh said in an equity research note dated yesterday.

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

Medtronic touts economic data for HeartWare HVAD

Medtronic's HeartWareMedtronic (NYSE:MDT) today touted more data on the HeartWare left-ventricular assist device it acquired in 2016, saying economic analyses of prior trials showed its cost effectiveness.

The Fridley, Minn.-based medical device giant said one analysis, of data from the Lateral thoracotomy study showed that patients implanted with its HVAD pump incurred lower hospitalization and medical supply costs than patients implanted via sternotomy. The average total cost per thoracotomy patient was $204,107, compared with $260,492 for traditional median sternotomy. Lateral also showed an 87% survival rate at two years and a 30% in length of hospital stay for thoracotomy patients, compared with sternotomy patients.

The second analysis studied HVAD as a bridge to heart transplant or as a so-called “destination therapy” for patients too sick to undergo a transplant, using data from four studies, Medicare and Seattle Heart Failure Model estimates. Incremental cost effectiveness in bridge-to-transplant patients was ⅔ lower ($69,561) for HVAD patients, compared with $226,300 in 2014. In destination therapy patients, the ICER was $102,499 for the HVAD device, compared with $209,400 to $802,700 for competitive LVADs.

Results from both analyses were presented in London last week at the annual meeting of the International Society for Heart & Lung Transplantation.

“These economic analyses illustrate the value of the HeartWare HVAD System for patients with advanced heart failure,” cardiac rhythm & heart failure CMO Dr. Rob Kowal said in prepared remarks. “Most important are the patient benefits – shorter hospital stays and improved survival – with the less-invasive thoracotomy approach, but there are also healthcare system benefits tied to patients spending fewer days in the hospital and their related supply costs.”

“These studies help us understand the cost effectiveness and economic value of the HVAD System, demonstrating a greater level of cost effectiveness than previously reported for LVAD therapy,” added Dr. Scott Silvestry of Orlando, Fla.’s AdventHealth Transplant Institute. “The progress toward greater cost effectiveness is an important advance that will support wider adoption of LVAD therapy for indicated patients.”

Last week Medtronic touted a retrospective analysis of two studies showing that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.

Medtronic, BCBS Minnesota ink value-based diabetes deal

Medtronic logo updatedMedtronic (NYSE:MDT) said today that it inked a deal with Blue Cross & Blue Shield of Minnesota on an outcomes-based program for diabetes patients.

The plan gives BCBS Minnesota members access to Medtronic’s Guardian Connect continuous glucose monitor via a pharmacy benefit, with payments pegged to how long patients spend in a targeted blood glucose range. The deal also includes access to the company’s Inner Circle patient engagement program, which aims to use gamification to improve outcomes, for people using Guardian Connect and Medtronic’s MiniMed 670G pump.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic touts new targeted drug delivery study results

Medtronic logo updatedTargeted drug delivery and conventional medical management have shown to have a reduction in healthcare use and costs for cancer patients in comparison to conventional medical management alone, according to a new study from Medtronic.

The study found that there were significant cost savings to payers and fewer inpatient visits with shorter inpatient stays. It also showed that there were fewer emergency department visits for people who used targeted drug delivery (TDD) and conventional medical management (CMM).

Medtronic suggests that TDD therapy had a significant average overall cost savings of $63,498 with fewer opioid prescriptions per patient. The company says that TDD, when delivered through Medtronic’s SynchroMed II Infusion System, could be an alternative to oral opioids.

Get the full story on our sister site, Drug Delivery Business.

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Medtronic touts stroke data for HeartWare LVAD

Medtronic logo updatedA retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.

The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.

The 465-patient Endurance Supplemental study compared 308 patients implanted with the HeartWare HVAD and 157 patients implanted with arch-rival Thoratec‘s HeartMate II device; the HVAD-treated cohort was also managed with a pre-specified blood pressure strategy to try to cut the stroke rates seen in earlier trials.

Endurance Supplemental’s primary endpoint was the rate of transient ischemic attack or stroke with 24-week residual deficit at 12 months. Secondary endpoints included a composite of freedom from death, disabling stroke and device replacement or urgent transplantation and a comparison of stroke or transient ischemic attack between the HVAD-treated cohorts in Endurance Supplemental and the original Endurance trial.

Although Endurance Supplemental missed the primary endpoint, with a 14.7% stroke rate for the HVAD cohort and 12.1% for the HeartMate II group, HVAD patients a 76.1% rate of freedom from the secondary endpoint’s adverse events compared with 66.9% for the control arm. Stroke rates were 24.2% lower for the HVAD cohort in the second trial compared with Endurance and hemorrhagic cerebrovascular accident was reduced by 50.5%.

Today Fridley, Minn.-based Medtronic said the two-year rate of freedom from disabling stroke for the HVAD group was 91%. Patients with the HeartWare device who had a stroke of any severity showed a lower rate of stroke-related mortality than patients implanted with HeartMate II, at 17% compared with 27%, respectively, the company said.

And there was a 23% reduction in total strokes, a 36% reduction in disabling strokes and a 39% reduction in stroke-related mortality in the HVAD arm of Endurance Supplemental, compared with the same arm in Endurance.

“This analysis shows that stroke severity is an important determinant of outcomes, and the use of the HVAD system with a guidelines-based blood pressure management strategy can, in addition to reducing overall stroke rates, reduce the occurrence of disabling stroke and improve survival in patients who experience strokes,” Dr. Jeffrey Teuteberg, of Stanford University, said in prepared remarks. “We also found that patients with a stroke in the HVAD cohort had better survival than those who received the control device. These results reinforce the importance of blood pressure management with the HVAD for end-stage heart failure patients.”

Medtronic said it’s also running a pair of real-world studies on the HVAD device, a 300-patient post-approval review of destination therapy patients called DT PAS and Apogee, which is designed to examine best practices in blood pressure management, anticoagulation/anti-platelet therapy and implant procedure in a DT PAS subset.

“Medtronic aims to advance the field of mechanical circulatory support and, consequently, the overall management of heart failure patients who can benefit from the therapy,” added cardiac rhythm & heart failure CMO Dr. Rob Kowal. “Continuing to define and drive best practices that reduce pump-related adverse events in a real-world setting is central to this patient-first strategy.”

Medtronic paid $1.1 billion in August 2016 for HeartWare, after cross-town rival St. Jude Medical paid $3 billion for Thoratec in October 2015; Abbott (NYSE:ABT) paid $25 billion for St. Jude in January 2017.

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The 10 largest orthopedic device companies in the world

skeleton bones orthopedic device companies orthopedics ortho

[Image courtesy of Unsplash]

Robot-assisted surgery continues to generate headlines in the orthopedics space. But there is so much more going on among the world’s largest orthopedic device companies.

Go to our sister site Medical Design & Outsourcing and discover what’s new among the 10 largest companies in the medical device industry’s ortho sector.



Note: Medical Design & Outsourcing drew on research for its annual Big 100 list of largest medical device companies to create the 10 largest orthopedic device companies list.


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Medtronic seeks another bite at the apple in $24m patent loss to spine doc inventor

Medtronic logo updated

Medtronic (NYSE:MDT) asked a federal appeals court for a full-bench review of its nearly $24 million loss in a patent infringement lawsuit brought by a physician inventor.

In February 2014, Dr. Mark Berry alleged that Fridley, Minn.-based Medtronic infringed on three patents covering a “system and method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions.”

In November 2016, a jury in the U.S. District Court for Eastern Texas sided with Barry, awarding $15.1 million for infringement of one patent, more than $2.6 million for infringement on the second and $2.6 million for overseas infringement. In January 2017 a judge reduced the $20.3 million verdict by $2.6 million, ruling that Barry did not present sufficient evidence on the overseas violation but upholding the U.S. infringement claims. Later that year, the court awarded total damages of nearly $24 million.

In January the U.S. Court of Appeals for the Federal Circuit issued a split 2-1 opinion affirming the lower court’s decision. In a March 27 filing, Medtronic asked the appeals court to seat its full complement of judges for a review of the case, arguing that the dissenting judge’s argument on one of the patents should carry the day.

“In Dr. Barry’s case, all of the foregoing considerations – the lack of records indicating experimentation, the normal fee charged, the control exercised, and the failure to inform customers of experimental purpose – would look the same if the surgeries were for commercial purposes. The only thing that affirmatively suggests these surgeries were experimental is that Dr. Barry said they were – after the fact, during litigation. As a matter of law, that is insufficient to show experimental purpose,” Judge Sharon Prost wrote in the dissent. “The record in this case shows that Dr. Barry waited too long to file for the ‘358 patent and that the on-sale bar applies.”

“Rehearing is warranted to reaffirm that such post hoc testimony, unsupported by contemporaneous objective evidence, cannotsave otherwise-invalid patent claims from operation of the statutory on-sale and public use bars,” Medtronic wrote in its rehearing petition.

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Sterilization plant closures: Here’s why you need to care

(Image by Jose Fontano on Unsplash)

The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant.

Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. With a Viant sterilization plant in Grand Rapids, Mich. slated to close later this year, the FDA is warning of spot shortages, and smaller medtech companies may be the hardest hit.

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

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