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.




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.”

Angel Medical’s Guardian implantable heart monitor fails on efficacy endpoint

AngelMed GuardianA clinical trial of the Guardian implantable heart attack monitor made by Angel Medical Systems failed to meet its efficacy endpoint, but suggested that the device could be used to help detect “silent” heart attacks.

Wilmington, Del.-based AngelMed won FDA clearance a year ago for the Guardian device for patients with prior acute coronary syndrome events including myocardial infarctions or unstable angina at high risk for further ACS events. Its 907-patient Alerts study randomized patients implanted with Guardian to either six months with the alert function active for the treatment group or six months without activation for the control arm; both groups had the alert function activated after the six-month randomized stage.

The primary efficacy endpoint, a confirmed occlusive event within 7 days, was not significantly reduced for the treatment arm at 3.8%, compared with 4.9% for the control arm. The primary safety endpoint was met a 96.7% rate of freedom from device-related complications, according to the study, published in the Journal of the American College of Cardiology and presented last month at the annual Cardiovascular Research Technologies conference in Washington, D.C., by principal investigator Dr. Michael Gibson.

However, the Guardian device cut detection-to-arrival-time from 30.6 hours to 51 minutes and an expanded analysis showed a higher predictive value and lower false positive rate for the treated cohort.

“Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events,” wrote the study’s authors, all of whom received research grants from AngelMed, including one who owns a stake in the company.

“As Dr. Gibson discussed in his presentation, the Guardian has shown that it can get patients to the ER even if they do not have symptoms of ACS events, including silent heart attacks. This is a first-ever capability for any product and allows the Guardian to fill an unmet medical need by providing more effective diagnosis of a life-threatening condition compared to relying on patient symptoms alone,” AngelMed CEO David Fischell said in prepared remarks.

Last last month the company emerged from Chapter 11 bankruptcy protection with a $10 million Series A round.

Conformal Medical launches LAA seal study

Conformal MedicalConformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.

Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to

The primary outcome is freedom from adverse events at 45 days, defined as all-cause mortality, ischemic stroke, systemic thromboembolism, device- or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention. Secondary outcomes include closure success at 45 days, 6 months and a year and major adverse events measured annually out to five years.

Conformal said the first-in-human use of the LAA seal, in a 63-year-old mountain biker with a history of bleeding episodes with anticoagulation drugs, was performed at the New York-Presbyterian/Columbia University Medical Center in New York City by Dr. Robert Sommer. The patient was discharged the day after his successful implantation on dual anti-platelet therapy per the study’s protocol, the company said.

“First-in-human use marks an important milestone for advancing our approach to stroke prevention,” president & CEO Andy Levine said in prepared remarks. “The experienced team at Columbia is providing valuable insights for optimizing the care of their patients.”

“It is exciting to participate in the first-in-human use of the Conformal device. The form-fitting seal is a promising advance in LAA closure for stroke prevention,” Sommer added.

“Columbia is excited to be the first to introduce this technology to patients,” Interventional Vascular Therapy Center director Dr. Martin Leon said. “I applaud Conformal’s commitment to utilize the FDA’s EFS Program. The ability to participate in early feasibility studies is important for the U.S. device ecosystem as we strive to develop new therapies to better serve our patients.”

Last December Conformal raised $9 million in a Series B round led by Catalyst Health Ventures that included some of its Series A investors.

Synchron’s thought-to-text tech starts clinical trial

Synchron’s Stentrode technology is designed to restore communication to people with paralysis. (Image from Synchron)

Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis.

The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications technologies.

Stentrode was designed to be small and flexible enough to safely pass through curving blood vessels in a procedure called cerebral angiography, eliminating the need for open brain surgery, according to Campbell, Calif.-based Synchron. By using blood vessels to deliver the technology to the brain, the technique may reduce risk of brain tissue rejection of the device, which has been a significant problem for other techniques, the company said. BrainOS is a modular training software powered by artificial intelligence that enables patients to control assistive technologies directly through thought.

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J&J’s Ethicon touts economic study of magnetic Torax GERD device

Ethicon's Torax Linx GERD deviceJohnson & Johnson (NYSE:JNJ) subsidiary Ethicon touted a study showing that the Linx device it acquired two years ago was cheaper than laparoscopic Nissen fundoplication in treating gastrointestinal reflux disease.

Shoreview, Minn.-based Torax Medical makes the Linx device, an implant of interlinked titanium beads with magnetic cores designed to augment the esophageal sphincter to prevent reflux in GERD patients. Ethicon paid an unspecified amount for Torax in March 2017.

Presented last week at the annual meeting of the Society of American Gastrointestinal & Endoscopic Surgeons in Baltimore, the study was funded by Ethicon and Highmark Health’s Vital incubator. It compared total procedural cost and disease-related and overall medical claim costs 12 months before and 12 months after 180 Linx patients and 1,130  LNF patients at Highmark’s Allegheny Health Network in Pennsylvania. Laparoscopic Nissen fundoplication wraps a portion of the upper stomach around the lower esophagus to prevent reflux.

The mean per-member-per-month reimbursement claims for upper GI disease one year after Linx dropped 66% percent to $104 and 46% for LNF, according to the study. Overall PMPM claims fell 10.7% for Linx patients and 1.4% for LNF patients; reimbursement for proton pump inhibitors and GERD acid suppression drugs fell 95% after Linx and 90% after LNF.

The average Linx procedure was more expensive, costing $14,379 compared with $13,691 for LNF. The difference is offset by lower costs a year out, the researchers said.

“The higher initial cost of a Linx procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which made getting insurance approvals challenging,” lead researcher Dr. Blair Jobe, director of Allegheny’s  Esophageal & Lung Institute, said in prepared remarks. “This study suggests that perception may be short-sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”

“This study demonstrated that the Linx System was cost effective and should be more widely covered by insurers,” added Ethicon endomechanical president Tom O’Brien. “Ethicon will continue to help support studies that enable clinicians, patients, insurers and health systems to make the best possible decisions about which treatments work best for which patients and at what cost.”

AirXpanders touts study results

AirXpanders (ASX:AXP) said that a retrospective clinical study has concluded that the use of its AeroForm tissue expanders may be associated with reduced infection rates, less medical treatment and lower costs for patients and health systems.

The Palo Alto-based company makes the AeroForm tissue expander for post-mastectomy breast reconstruction. The device is designed to expand and stretch the skin and underlying muscle prior to a permanent breast implant using small amounts of CO2 up to three times a day.

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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 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.

The post Medtronic touts stroke data for HeartWare LVAD appeared first on MassDevice.

Orthofix Medical touts data from artificial disc study

Orthofix Medical’s M6-C artificial cervical disc (Image from Orthofix)

A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today.

Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion (ACDF) patients, and 92% reported they were satisfied with the surgery, the Lewisville, Texas-based business said in a prepared statement.

At 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those in the M6-C disc group, the study showed. In the M6-C group, 92% reported that were satisfied with the surgery.

“The results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty versus discectomy with fusion,” said Dr. Jack Zigler, an orthopedic spine surgeon at Texas Back Institute and an investigator in the study. “A significant reduction in pain, the maintenance or improvement of neurological function, and the preservation of natural disc motion after 24 months were all meaningful clinical benefits the M6-C disc patients experienced when compared to the fusion control.”

Zigler presented the study results during the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in Anaheim, Calif.

A prospective, non-randomized, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 U.S. sites with an average patient age of 44 years. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level symptomatic cervical radiculopathy with or without cord compression. The overall success rate for the protocol-specified primary endpoint for the M6-C disc patients was 86.8% at 24 months and 79.3% in the control group. This data statistically demonstrate that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF.

M6-C disc patients demonstrated statistically significant improvement in the Neck Disability Index as measured at week six and months three, six, 12 and 24. Before surgery, 80.6% of the M6-C disc patients and 85.7% of the ACDF patients were taking pain medication for the treatment of their cervical spine condition. At 24 months, the rate of M6-C patients still taking pain medication dropped to 14% compared to 38.2% of the ACDF patients. Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.

Average mean surgery time for the M6-C disc was 74.5 minutes versus 120.2 minutes for the ACDF procedure. M6-C patients also had shorter hospital stays and fewer needed follow-up surgery than ACDF patients.

The M6-C artificial cervical disc is made of ultra-high molecular weight polyethylene fiber wrapped in a specific pattern, with multiple redundant layers that create a fiber matrix (artificial annulus). The fiber is then wound around a polycarbonate urethane polymer core creating an artificial nucleus. Like a natural disc, this unique construct allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements, according to the company.

“With the recent FDA approval of the M6-C artificial cervical disc, we are excited to be able to provide spine surgeons and their patients a new and innovative alternative to the ball-and-socket artificial disc designs currently available in the U.S.,” said global president of Orthofix Spine Brad Niemann in a prepared statement. “What makes the M6-C disc so unique is its physiologic single-piece design featuring an artificial nucleus and annulus that work together to mimic the biomechanical motion of a natural disc to include axial compression or shock absorption, which no other disc available in the U.S. has to offer.”

Orthofix said it will release the M6-C disc in 2019 through a controlled, limited market launch in the U.S. accompanied by an extensive training and education curriculum for surgeons. The device CE Mark approval for distribution in the E.U. and other countries in 2006; there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the U.S. to date.