Glaukos touts 5-year study of glaucoma stents

Glaukos  (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said.

The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two iStents achieved a 35.3% reduction in mean intraocular pressure (IOP) to 16.5 mmHg. The prospective, controlled, multi-surgeon clinical trial pitted evaluated the five-year safety and efficacy of two iStents vs. topical prostaglandin as an initial intervention in POAG subjects who had not had prior glaucoma treatment. A total of 101 subjects were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or once-daily topical travoprost, a commonly prescribed prostaglandin. The results were published in Ophthalmology Glaucoma.

Treatment success — defined as mean diurnal IOP of 6 mmHg to 18 mmHg without add-on medication or secondary glaucoma surgery — was achieved in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04). Seventeen percent of stent eyes vs. 44% of travoprost eyes required add-on medication.

The need for add-on medication arose at a slower rate in the stent group than in the travoprost group, especially after two years of follow-up. Study authors observed that from two to five years of follow-up, add-on medications were initiated in roughly double the number of travoprost eyes vs. stent eyes. The safety profile was excellent in both groups throughout follow-up, according to the San Clemente, Calif.-based company.

“Topical ocular hypotensive medications are typical first-line glaucoma therapy but these drugs can be ineffective due to high rates of patient non-adherence, ocular surface damage, cost and other factors,” said ophthalmic surgeon and lead author Dr. Robert Fechtner in a prepared statement from Glaukos. “This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.”

Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here.

“This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Glaukos prez & CEO Thomas Burns. “Moreover, it adds meaningful outcomes data to the growing body of peer-reviewed evidence that implantation of a single or multiple iStents can reliably achieve sustained IOP reductions in an elegant, tissue-sparing procedure with a highly favorable safety profile.”

Today’s announcement was good news for Glaukos, whose iStent recently fared worse in a two-year study that compared it to competitor Ivantis’ Hydrus Microstent. The Ivantis study touted reductions in medication use and no reoperations for patients in the Hydrus arm.




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.

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

FDA approves Intact Vascular’s Tack dissection repair device

Intact VascularThe FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular.

The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017.

The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputation or all-cause death, its primary safety endpoint, was 86.5%. The trial met its efficacy endpoint with a 79.3% primary patency rate at 12 months. And 92.1% of all dissections were completely resolved, according to results presented at last year’s Vascular InterVentional Advances conference in Las Vegas by principal investigator Dr. William Gray.

Intact Vascular said the trial, which it touted as the first to enroll PAD patients with 100% dissected vessels, also showed 0.5% bailout stent rate and zero implant fractures.

“FDA approval of the Tack endovascular system comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” president & CEO Bruce Shook said in prepared remarks. “Now with the Tack endovascular system available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients.”

“I look forward to having the Tack implant available for my patients,” added Gray, of Wynnewood, Pa.’s Lankenau Heart Institute. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”

Intact said it’s planning a limited U.S. release “that will progress toward broader market commercialization.” The company raised a $20 million Series C round in April 2018.

EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

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

FDA: Duodenoscope reprocessing is dirtier than we thought

Superbug endoscopeThe FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear.

Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effectiveness of reprocessing the scopes; last year it sent the trio another set of warning letters over their failure to comply with that order.

Today Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, warned of possible “additional action” if the companies don’t meet their deadlines.

“While the firms have made some progress toward completing these studies, they are still not in compliance with the timetable they agreed upon to complete these studies. If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action,” Shuren said in prepared remarks.

Although the number of adverse event reports for the devices fell 62%, from 250 in 2015 to fewer than 100 in 2017, a spate of 205 reports from last October to the end of March included 45 patient infections, one patient exposure and 159 contaminated devices; there were three U.S. deaths reported last year from duodenoscope infections, according to the FDA.

And as of last December the FDA thought that the contamination rate for high-concern bugs like E. coli and Pseudomonas aeruginosa was 3%. New data show that number to be more like 5.4%, the agency said.

“Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further,” Shuren said, noting that the FDA is considering whether more stringent action is necessary to get infection rates under 1%.

“For example, we are exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning, might offer a more effective option. This will take careful consideration because we know some sterilization methods could damage the duodenoscope over time and lead to a shorter lifespan for the expensive device,” he said.

The FDA is also consulting the Centers for Disease Control & Prevention and other health agencies “to obtain their input and guidance on the issue of infection control and reprocessing of these difficult-to-clean scopes,” Shuren said.

Ex-MiMedx CEO Petit mounts proxy war


MiMedx (NSDQ:MDXG) is facing a proxy battle being led by former CEO Parker Petit, who was ousted last July “for cause”, according to a recently posted SEC filing.

The ex chief-exec nominated himself alongside former Pulte Home Corp tax director David Furstenburger and George & Lorenson partner Shawn George as candidates for the company’s board of directors, set to be elected at an upcoming shareholder’s meeting.

Petit said that he believes that the current MiMedx board has “failed shareholders with disappointing performance, failure to ensure competent leadership and lack of engagement with MiMedx shareholders.” He added that he “felt compelled to launch a contest seeking changes on the board,” according to the filing.

“In my opinion, the current board has done a major disservice to MiMedx’s shareholders and there is no sign the board has the ability, judgment or commitment to return MiMedx to its former growth and profitability as a NASDAQ listed company. Shareholders have been left in the dark while the company’s value has significantly dropped. I could no longer sit on the sidelines. Together with Shawn and David, we, if elected, will bring a wealth of experience working on and resolving expeditiously highly contentious and complicated matters. I believe that our slate of candidates will instill the much needed accountability and reason in the boardroom that MiMedx is now lacking, while supporting its valuable employees and expanding its best in class intellectual property patents,” Petit said, according to the SEC filing.

MiMedx faced a number of troubles last year, including the ouster of Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June.

At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into the matter.

The company later said that all four executives’ departures were for cause, triggering the forfeit of all equity and incentive awards for the executives and Petit’s resignation from the board. Petit and Taylor denied the allegations in a statement from their lawyer.

In December, the accounting firm tapped to audit MiMedx’s books resigned in the wake of the financial issues the company faced.

Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case

J&J's EthiconA state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products.

Plaintiff Sharon Carlino was awarded $13.5 million in damages in February 2016, after a Keystone State jury found that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks; Carlino needed three revision surgeries to remove the eroded mesh. That decision was upheld early the following year, with the court adding some $238,000 in delay damages.

Ethicon and Carlino cross-appealed, with the company pressing seven arguments seeking to overturn the decision and Carlino arguing that the delay damage award should have been calculated on both compensatory and punitive damages, not just the compensatory award.

Yesterday the Pennsylvania Superior Court ruled on the cross-appeals, backing the lower court’s decision on all fronts, including Ethicon’s challenge to the punitive damages award and the delay damages ruling.

“Taken as a whole, and viewed in the light most favorable to the verdict winner, this evidence permitted the jury to find Ethicon acted with wanton and willful disregard of Ms. Carlino’s rights and that this conduct caused her injuries. The evidence showed that Ethicon knew that the TVT could cause permanent vaginal and muscular pain and sexual dysfunction, because of its mesh weight, pore size, pore collapse, and particle loss. Despite this knowledge, Ethicon promoted the TVT for patients who sought to fix SUI, knowingly understated the risks of the TVT in its IFU, and consistently misled physicians that the TVT produced few adverse results,” the Superior Court found.

“The evidence demonstrates that Ethicon knowingly understated the risks of the TVT in all six versions of the [instructions for use] published between 2000 and 2015. The IFU’s adverse reactions section did not change during that time, and it failed to acknowledge new information Ethicon was obtaining from treaters and its own researchers on adverse effects associated with the TVT. In addition, Ethicon consistently and misleadingly informed physicians that the TVT produced few adverse results and was intentionally evasive about common complications,” according to the ruling.

In January a Philadelphia jury hit Ethicon with a $41 million decision in another pelvic mesh suit brought over its Gynemesh, Prolift and TVT-O meshes. That verdict includes $25 million in punitive damages, $15 million in compensatory damages and $1 million for loss of consortium.

Ethicon has said it intends to appeal the decision and that it stands by its pelvic mesh products.

Align Technology puts $31m price tag on forced retail store closures

Align Technology

Align Technology (NSDQ:ALGN) yesterday put a price tag of as much as $31 million on the forced closure of its Invisalign retail outlets after losing arbitration with SmileDirectClub last month.

The March 4 decision required San Jose, Calif.-based Align Technology to close the stores by April 3 and enjoined it from opening new Invisalign stores or providing clear aligner devices in brick-and-mortar stores.

First piloted in 2017, the number of Invisalign stores had risen to 12 by last year. Yesterday the company said it expects the closures to result in first-quarter charges of between $26 million and $31 million, including cash payments of $12 million to $17 million this year.

The charges involve $11 million to $16 million in right-of-use lease assets, $14 million in leasehold improvements and other fixed assets and severance expenses of $1 million, Align said in a regulatory filing.

5 digital health startups you need to watch in 2019

(Image from Unsplash)

Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI).

Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the most funding of any function in 2018, $3 billion across 193 deals.

Here are five of the up-and-coming digital health companies to watch in 2019:

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

Second Sight Medical releases early feasibility data on Orion cortical implant

Second Sight Medical's Orion cortical implantSecond Sight Medical (NSDQ:EYES) today announced preliminary results from a small feasibility study of its Orion cortical implant, which is designed to give eyesight to the blind.

Sylmar, Calif.-based Second Sight’s Orion is designed to connect the camera in a pair of eyeglasses with an implant that receives the camera signal and translates it to the visual cortex in the brain, bypassing the eye and the optic nerve entirely. The company’s Argus II device, which uses a retinal implant to receive the camera’s signal, is already on the U.S. market.

Interim data from a five-year early feasibility study, presented today at the annual meeting of the Brain Research through Advancing Innovative Neurotechnologies conference in Washington, D.C., involved five patients with bilateral blindness from any cause other than damage to the visual cortex.

The primary safety outcome for the study is the rate of adverse events, with secondary outcomes including phosphene production, long-term device function, benefit to visual function and quality of life. The first subject was implanted  in January 2018.

The study showed a significant improvement in the ability to locate a high-contrast target for three of five subjects at six months. Two of the five patients showed significantly better at determining the direction of motion of a high-contrast target. All five patients were rated by certified specialists as having improved functional vision and well-being.

“Observations from rehabilitation sessions include that subjects are able to use Orion to visually detect parked cars, identify the direction of motion of a person walking by, and visually order small objects by size,” Second Sight said.

There was one serious adverse event when a patient had a seizure and four non-serious adverse events, the company said, noting that there were no unanticipated adverse device effects as of Feb. 8.

“We are delighted to share preliminary Orion feasibility study findings with this esteemed group of investigators. This conference provides a forum for discussing exciting advancements and to continue to engage with other scientists who are conducting cutting-edge research in the field,” president & CEO Will McGuire said in prepared remarks. “We are encouraged by the progress Orion subjects are making on visual function endpoints like square localization and direction of motion. With the help of our highly-trained low-vision specialists, our subjects are using Orion at home to perform everyday visual tasks that they cannot do without the system. We look forward to completing the analysis of 12-month data from the Orion Early Feasibility Study and to future refinements that enhance Orion’s ability to provide useful artificial vision to blind individuals.”