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.




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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Irish medtech startup wins $3M in grants

The BioHealx technology is designed to treat anal fistula. (Image from Signum Surgical)

Galway, Ireland-based startup Signum Surgical said today that it has landed more than $3 million in grants to help fund its efforts to gain U.S. and European regulatory clearance of a device intended to treat a condition that can cause fecal incontinence.

The grants include $2.04 million from the European Union Horizon 2020 SME Instrument and $1.15 million from Ireland’s Disruptive Technologies Innovation Fund (DTIF). Part of the money will help Signum Surgical launch of a 12-month clinical study of its BioHealx device, which is designed to treat anal fistula. An anal fistula is an artificial tunnel between the rectum and skin of the buttocks that can develop due to an infected or blocked anal gland. If left untreated, an abscess may form, and the infection may travel through the patient’s sphincter muscle. The condition primarily affects young men and up to one in 5,000 people worldwide, according to a 2011 study published in Deutsches Ärzteblatt International. 

Current treatments are rarely successful, leaving patients to suffer from ongoing infections and causing many to undergo multiple procedures, according to the company. The BioHealx technology includes a bioabsorbable implant designed to help seal the fistula tract and dissolve in the body after treatment. The implant is placed via a minimally invasive, outpatient procedure designed to encourage healing, prevent reinfection, and protect patient continence, the company said.

The new grants follow a $2.3 million Series A investment round that closed in 2016. The Series A round was led by Halo Business Angel Network’s MedTech Syndicate, with additional investments from Enterprise Ireland, the Western Development Commission, Rising Tide Europe, and other angel investors.

“We are delighted to be awarded both the DTIF and Horizon 2020 SME grants, which validate the need for a viable solution where other approaches have been unsuccessful in treating this patient population,” said Signum Surgical co-founder and chief technology officer Eoin Bambury in a prepared statement. “With this funding, we look forward to accelerating the commercialization of BioHealx technology to help alleviate the suffering of people with anal fistulas — a debilitating condition that severely affects patients’ quality of life.”

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.

Treace Medical touts results of bunion surgery study

Treace Medical’s Lapiplasty bunion procedure is designed to correct foot bone alignment and stabilize the toe. (Image from Treace Medical)

Treace Medical Concepts said a study of its bunion implant surgery showed more rapid healing than traditional osteotomy.

The study of the Ponte Vedra, Fla.-based company’s Lapiplasty 3D bunion correction system showed that most patients were able to stand on their operative foot five days after surgery and had a high rate of healing nine months after the procedure.

The study enrolled 195 patients, including 19.5% who had comorbidities known to compromise bone healing, with a mean follow-up of 9.5 months. Ninety-seven percent of the patients demonstrated a successful bony fusion of the joint and 98.9% maintained a stable joint position over the course of the study, which was published in The Journal of Foot & Ankle Surgery. The implant removal rate was 3.1% compared with conventional plate implants where published removal rates can be greater than of 17% for tarsometatarsal and 20% for big-toe joint fusion procedures.

The Lapiplasty procedure is designed to reproducibly correct all three planes of the bunion deformity and address the root cause of the bunion while allowing patients to get back to their active lives quickly. A bunion, or hallux valgus, is a foot deformity that affects about 60 million Americans and results in approximately 400,000 surgeries in the U.S. annually, according to the company.

“This study demonstrated positive bone healing rates over progressive timepoints when utilizing biplanar plating without a cross-joint compression screw in procedures used to treat bunions or arthritis of the big toe joint,” said lead author Dr. Paul Dayton of the Midwest Bunion Center (Des Moines, Iowa), in a prepared statement. “The bone healing rates were quite encouraging, given this unique fixation approach allowed patients to undergo an accelerated recovery protocol and to initiate weightbearing in a post-operative boot within their first week of surgery.

“Overall, I’m very pleased with these results as they reinforce that I can offer this fixation option to my patients with a high level of confidence that they will experience reliable bone healing under an accelerated weight-bearing protocol.”

“The outcomes of this new study are noteworthy in that they closely mirror those reported in our 13-month multicenter dataset presented at the 2018 American Orthopaedic Foot & Ankle Society’s (AOFAS) annual meeting in Boston,” added Dr. Robert Santrock of West Virginia University and co-author on this new publication. “In the AOFAS dataset, the 61 feet treated with Lapiplasty 3D Bunion Correction showed low 1.6% symptomatic non-union rate and 3% radiographic recurrence rate. Patients in the AOFAS study initiated weightbearing in a post-operative boot at an average of 10.5 days, which is consistent with this new study.”

“The rapid time to weightbearing, high rate of bone healing, and low implant removal rate reported in this study further highlight the patient benefits of biplanar plating — the fixation method used in the Lapiplasty procedure,” said Treace Medical CEO John  Treace. “The study represents the 9th peer review publication supporting the Lapiplasty procedure, another important milestone for our company.”

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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.

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1st U.S. patient treated with Cook Medical endovascular aortic dissection system

Cook Medical’s Zenith endovascular dissection system consists of two stents to treat a tear within the aorta. (Image from Cook Medical)

Cook Medical said it has launched its Zenith dissection endovascular system, recently approved by the FDA. The first patient was treated with the system at Cooper University Health Care in Camden, N.J., according to the company.

The Zenith system was designed to provide physicians with a less-invasive alternative to open surgery for repair of Type B dissections of the descending thoracic aorta. Zenith consists of a proximal stent-graft component and a distal bare-stent component.

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Bayer loses bid to toss some claims in Essure class action suit

A federal judge in Philadelphia will allow six women who are suing Bayer (ETR:BAYN) over its Essure sterilization implant to proceed with their personal injury claims and three others to pursue their breach-of-warranty claims. One woman who became pregnant following implantation with Essure will be able to pursue her claim that Bayer fraudulently concealed the risk of pregnancy, the judge ruled.

Bayer had filed a motion for partial summary judgment on all 12 plaintiffs’ claims in the class action suit, citing statutes of limitations. Judge John Padova of the Eastern District of Pennsylvania granted Bayer’s motion for summary judgment on the personal injury claims of six of the women and on some or all of the breach-of-warranty claims of nine women.

The women had the Essure coils implanted in their fallopian tubes between 2006 and 2013 and claimed they suffered a variety of ailments afterward, including pain, bleeding and autoimmune disorders. Two became pregnant.

Under Pennsylvania law, the women had two years to file claims seeking damages for personal injury and four years to file claims for breach of warranty. Bayer and some of the women differed on when the clock began to run, based on when the women — or their doctors — connected their health problems to Essure and when they filed suit.

Padova heard the arguments on Bayer’s motion on February 11. Bayer took Essure off the market in the United States in December 2018. In April of 2018, the FDA put restrictions on U.S. sales of Essure, a small metal coil that’s placed in the fallopian tubes via catheter, after concluding that some patients were not adequately warned of its risks.

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Can a lifetime guarantee boost value-based care?

Cheryl Bednar, 54, of Laflin, Penn., suffered from chronic pain from hip deterioration until Geisinger Dr. James Murphy performed a hip replacement in February 2018 and offered the lifetime guarantee. (Image from Geisinger)

Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries.

The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes. Medacta and Geisinger will share the costs of the implant and associated hospital fees while patients remain on the Geisinger Health Plan and are treated by Geisinger providers.

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Think Surgical, United Orthopedic join forces for global sales

Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system.

Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with clearance anticipated in 2019. The system’s core technology has been used in thousands of total hip and knee replacements worldwide, according to Fremont, Calif.-based Think.

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