Exactech wins FDA nod for Equinoxe stemless shoulder

Exactech (NSDQ:EXAC) said yesterday it won FDA clearance for its Equinoxe stemless shoulder prosthesis designed to be compatible for use with the Equinoxe shoulder system.

The Gainesville, Fla.-based company said the system is designed for anatomic total shoulder arthroplasty procedures and features a 3D porous structure and an incorporated bone cage for bone through-growth to increase biologic fixation.

“The Stemless Shoulder’s innovative combination of three-dimensional porous material and bone cage technology help differentiate it from others on the market. Exactech’s ability to convert design team concepts and ideas into a reality is quite impressive, and I am certain surgeons will be eager to learn more about this meaningful technology,” design team member Dr. Buddy Savoie III of Tulane University said in a prepared statement.

Exactech said it plans to launch a clinical study of the Stemless Shoulder immediately, and that it aims to “aggressively expand” the release of the device during the second half of this year.

“Our world-class design team and engineers deserve a lot of praise for this new product, and in particular, for an efficient product development process. Their ingenuity, coupled with their passion for clinical outcomes, allowed them to navigate this product to market very quickly, and is emblematic of our mission to help patients,” Exactech extremeties marketing VP Darin Johnson said in a press release.

Last month, Exactech announced the closing of its $737 million go-private sale to TPG Capital, with TPG acquiring all issued and outstanding stock of the company.

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FDA warns of imaging issues associated with neurovascular coils

The FDA warned this week that neurovascular embolization coils may increase image artifact when magnetic resonance angiography imaging is used to image a patient’s aneurysm after coiling.

Physicians use neurovascular embolization coils to treat brain aneurysms and often perform follow-up imaging after the procedure. Traditionally, doctors use digital subtraction angiography to image aneurysms after coiling, but sometimes healthcare providers opt for MRA since it doesn’t expose patients to ionizing radiation.

Data reviewed by the FDA showed that when MRA is performed on patients treated with coils containing 304V stainless steel, the resulting images show larger than expected MR artifact or image voids when compared to other devices.

“In these cases, the reduced quality of the MRA image from increased artifact can result in accurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions,” the U.S. regulatory agency wrote in a letter to providers.

The FDA also noted that most neurovascular embolization coils that are on the market as labeled as magnetic resonance conditional – meaning the device can be safely used in an MR environment.

“The product labeling for neurovascular embolization coils does not currently convey the extent of MRA image artifact caused by the device or the MRA imaging parameters that will yield the lowest amount of image artifact if MRA is used for patient follow-up,” the agency explained.

The FDA recommended that healthcare providers be made aware of the presence of 304V stainless steel in the coil systems typically used by their institutions. The agency said that if providers choose to use MRA for follow-up, they should opt for imaging parameters with the shorter echo times and a high readout bandwidth to minimize image artifact.

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The company behind Narcan looks toward a treatment for fentanyl overdoses

Despite growing attention from lawmakers and doctors, the opioid crisis is not slowing up in the U.S. A new report published last week by the Centers for Disease Control and Prevention showed that emergency room visits for opioid overdoses jumped 30% in 45 states from 2016 to 2017.

The problem has morphed over the years – fentanyl, a powerful opioid that’s 30 times more potent than heroin, has grown in popularity among drug users, despite its deadly grip.

A nasal spray designed to reverse opioid overdoses called Narcan has become a life-saving tool used by police departments and communities around the country. Now, the company that created Narcan – Opiant Pharmaceuticals (NSDQ:OPNT) – is hoping that its latest drug-device combination can help people who are overdosing from fentanyl.

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

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FDA clears shutdown of Lap-Band study for Apollo Endosurgery

Apollo Endosurgery (NSDQ:APEN) said late yesterday that the FDA approved the company’s move to terminate the Lap-Band lower body mass index post-approval study based on availability of long-term safety and effectiveness data on the device.

The trial was part of a bid for expanded indications, through which the FDA required the Austin, Texas-based company to conduct a prospective, multicenter, open-label, post-approval study to evaluate safety and effectiveness of the device in patients with BMIs between 30 and 39.9.

The study was slated to enroll 325 patients at 20 sites, with 181 subjects enrolled at 13 sites when it was terminated. Apollo said that with the early termination, it expects to save approximately $5.1 million, according to a press release.

Termination was approved based on the availability of long-term safety and effectiveness data on the Lap-Band in the lower BMI indications from existing published evidence. The company produced a final study report to the FDA which referenced 25 published studies exploring the use of the Lap-Band in lower BMI individuals.

Shares in Apollo Endosurgery have fallen 1.8% today, at $6.28 as of 10:34 a.m. EDT.

Earlier this month, Apollo Endosurgery saw shares fall after the medical device maker missed earnings per share expectations on Wall Street with its fourth quarter and full fiscal year 2017 earnings report.

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Medtronic wins FDA nod for connected, predictive CGM system

Medtronic (NYSE:MDT) said today that its Guardian Connect continuous glucose monitoring system won FDA approval for people with diabetes ages 14 to 75.

The medtech titan touted its system as the first connected standalone CGM designed to help people with diabetes avoid high and low glucose events.

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

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ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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MiMedx wins FDA regenerative med status for AmnioFix

MiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week.

The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee.

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

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Abbott wins FDA nod for pediatric Masters Series mechanical heart valve

Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world.

The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or mitral position and consists of two semi-circular discs that open and close in response to blood pressure changes during the heart beat, according to an FDA release.

The newly approved 15mm version of the device clears the valve for use in pediatric patients who previously had no options, the FDA said.

The agency claims that more than 35,000 babies are born in the US each year with congenital heart defects, many of which will require replacement heart valves that, prior to the approval, were not available.

“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” FDA Center for Devices and Radiological Health director Dr. Jeff Shuren said in a press release.

Approval came based off clinical data from a single-arm study of 20 pediatric patients, between the ages of 1.5 weeks and 27 months, with serious heart failure in which the device was used as a mitral valve replacement.

Data from the study showed that one year post-implant, survival rates were 69.3% while the rate of freedom from valve-related adverse events was 66.8%, according to the FDA release.

Serious adverse valve-related events noted during the study include blood clots in the device and brain bleeds. The FDA said that anticoagulation therapy may be required to help prevent device clotting.

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FDA clears software using AI to evaluate CT scans for stroke


Artificial Intelligence healthcare developer Viz.ai said this week it won approval from the FDA for its LVO Stroke platform designed to analyze computed tomography results and notify providers of potential strokes, touting it as the first such system to win FDA clearance.

The company’s LVO Stroke platform is designed using deep learning and connects to a hospital CT scanner to alert stroke specialists that a suspected LVO stroke has been identified, with the ability to send radiological images directly to the physician’s phones.

“Timely LVO stroke identification and transfer to a specialist hospital that can perform mechanical thrombectomy is the top priority for LVO stroke patients. This software is designed to help identify appropriate patients earlier and more often, and enable faster transfer and treatment, which, ultimately may result in improved patient outcomes,” Dr. Raul Nogueira of Emory University said in a prepared statement.

“This software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke,” FDA Center for Devices and Radiological Health’s radiological health acting deputy director Robert Ochs said in a prepared release.

Approval came supported by a 300-patient performance study of the system, with results indicating an AUC of 0.91, a 90% sensitivity to identifying LVOs and alerting specialists, and a median scan to notification time of under 6 minutes.

Results also indicated that automatic notifications saved an average of 52 minutes in over 95% of cases.

“The Viz.ai LVO Stroke Platform is the first example of applied artificial intelligence software that seeks to augment the diagnostic and treatment pathway of critically unwell stroke patients. We are thrilled to bring artificial intelligence to healthcare in a way that works alongside physicians and helps get the right patient, to the right doctor at the right time,” CEO Dr. Chris Mansi said in a press release.

Viz.ai said it won CE Mark approval in the European Union for the system in January.

Pacira shares fall after FDA committee rejects expanded use for Exparel pain drug

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