Johnson & Johnson shares rise on Street-beating Q1, lifted guidance

Shares in Johnson & Johnson (NYSE:JNJ) have risen today after the medical giant posted first quarter earnings that topped expectations on Wall Street and lifted its EPS guidance for the full fiscal year.

The New Brunswick, N.J.-based company posted profits of approximately $3.75 billion, or $1.39 per share, on sales of $20 billion for the three months ended March 31, seeing the bottom line shrink 14.2% while sales grew 0.1% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were $2.10, ahead of the $2.04 consensus on Wall Street where analysts expected to see sales of $19.6 billion, which the company also topped.

“Our strong first-quarter results reflect continued underlying operational sales and adjusted EPS growth. At the same time, we remain focused on investing in innovative technologies and platforms that will make a meaningful difference in the lives of patients around the world. I am proud of our global colleagues’ collective efforts to deliver on our long-term goals and our ability to create value for all of our stakeholders,” chair & CEO Alex Gorsky said in a press release.

Johnson & Johnson lifted its guidance for the remaining fiscal year, now expecting to see adjusted diluted EPS of between $8.53 and $8.63 up from previous guidance of between $8.50 and $8.65. The company maintains its sales expectation of between $80.4 billion and $81.2 billion.

Shares in Johnson & Johnson have risen 2.6% so far today, at $140.08 as of 9:47 a.m. EDT.

Earlier this month, Johnson & Johnson said that its  its Ethicon biz completed its $3.4 billion acquisition of robotic surgery dev Auris Health and the $2.8 billion divestiture of its Advanced Sterilization Products to Fortive (NTSE:FTV).

from MassDevice http://bit.ly/2XhKmSy

Egypt fast-track medical device registration pathway speeds up market access timeframes

By Stewart Eisenhart, Emergo Group

A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

from MassDevice http://bit.ly/2DrDqLt

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.

 

 

 

from MassDevice http://bit.ly/2Pf9ruD

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.

from MassDevice http://bit.ly/2v58oUX

Penumbra VR device wins FDA clearance

Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system.

The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the Real Immersive System are designed to be done in a seated position in a clinical environment, according to Penumbra.

The system features a clinician tablet, head-mounted display component, small sensors, large sensor, sensor charger, router, router battery, HMD controller, power cords and USB cables. The small and large sensors have mechanical and electrical components that can measure motion and direction in the physical space and then translate that information into a virtual environment.

from MassDevice http://bit.ly/2UiVDQX

Corindus touts first Japanese CorPath GRX procedures

Corindus Vascular Robotics (NYSE:CVRS) said today that the first Japanese procedures using its CorPath GRX robot-assisted device took place as part of a post-market surveillance study.

Waltham, Mass.-based Corindus, which last June won clearance from Japan’s Pharmaceutical & Medical Device Agency for CorPath GRX, inked a distribution deal for Japan in February 2017 that included a $2 million advance and provision for 12 of the devices; the system used in the initial cases there was the first placement of that deal and followed A1 technical fee reimbursement approval last month, Corindus said today.

CorPath GRX is used to assist cardiologists during percutaneous coronary interventions including stenting procedures.

“The acceptance of robotic-assisted PCI in Japan is an important next step for Corindus to bring this critical medical advancement to additional markets across the globe. Japan represents one of the largest markets for PCI globally, with over 1,200 hospitals performing nearly 250,000 PCI procedures annually,” president & CEO Mark Toland said in prepared remarks.

“After completing the first cases with CorPath GRX, I am impressed with the capabilities of the system, including the level of precision and control during complex procedures,” added Dr. Takafumi Ueno of Kurume University Hospital. “Robotics will provide Japan with cutting-edge technology in interventional medicine, and we are pleased to be one of the first facilities in the Asia-Pacific region to offer this treatment to our patients.”

“We are thrilled to have partnered with Dr. Ueno, Kurume University Hospital, and Japan Medicalnext to launch the first vascular robotic program in Japan, offering these patients the benefits of robotic-assisted PCI,” Toland said.

from MassDevice http://bit.ly/2ZaXcUy

FDA approves Intact Vascular’s Tack dissection repair device

The 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.

from MassDevice http://bit.ly/2XkdnNL