Intuitive Surgical wins another indication for da Vinci SP

Intuitive SurgicalIntuitive Surgical (NSDQ:ISRG) said today that it won another indication for the FDA for its da Vinci SP robot-assisted surgery device.

Initially cleared in April 2014 for urological procedures, in June 2018 the federal safety watchdog added a clearance for procedures requiring very narrow access from a single small incision. Today the Sunnyvale, Calif.-based company said the FDA added single-port radical tonsillectomy and tongue base resection procedures to the mix.

“Today’s FDA clearance means surgeons can utilize da Vinci SP robotic-assisted surgery to conduct radical tonsillectomy and tongue base resection transorally,” CEO Gary Guthart said in prepared remarks. “Our single-port innovation is part of our commitment to helping surgeons and their teams improve patient outcomes, decrease variability in surgery, and improve the patient and surgical team experience.

“Intuitive’s da Vinci SP complements our other systems by enabling surgeons to access narrow workspaces while maintaining high quality vision, precision, and control that surgeons have come to trust from da Vinci systems,” Guthart said.

The post Intuitive Surgical wins another indication for da Vinci SP appeared first on MassDevice.

FDA warns against robot-assisted breast cancer surgeries

FDA-logo-newFDA has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer.

The safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers, according to the agency, which said it “encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.”

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

The post FDA warns against robot-assisted breast cancer surgeries appeared first on MassDevice.

Intuitive Surgical wins FDA clearance for robotic-assisted lung biopsy system

Intuitive Surgical robotic assisted surgery Ion system lung cancer biopsy

Intuitive Surgical’s Ion system includes an articulating robotic catheter able to navigate through small and tortuous airways during lung biopsy procedures. [Image courtesy of Intuitive Surgical]

Intuitive Surgical (NSDQ:ISRG) said today that FDA has cleared its Ion system — a robotic-assisted, catheter-based platform meant to enable minimally invasive biopsy deep within the lung.

Sunnyvale, Calif.–based Intuitive plans to start selling the Ion system in the U.S. in a measured fashion; it’ll start shipping to customers in coming months.

The Ion system includes an articulating robotic catheter with an outer diameter of only 3.5 mm that is able to move 180 degrees in all directions, allowing a physician to navigate the catheter through small and tortuous airways to reach nodules. The system’s Flexision Biopsy Needle is also able to pass through tight bends as it travels through the Ion’s catheter to collect peripheral lung tissue. Other biopsy tools are also able to fit inside the catheter’s 2 mm working channel, including biopsy forceps or cytology brushes.

Fiber optic shape sensor technology in the Ion system provides the catheter’s precise location and shape information throughout the procedure. Intuitive officials say they designed the Ion system to easily integrate into existing lung nodule biopsy workflows.

“The Ion system represents Intuitive’s continued commitment to innovating for minimally invasive care, and extends our focus beyond surgery,” said Intuitive Surgical CEO Gary Guthart. “At Intuitive, we innovate for need, and lung cancer is clearly a global health challenge that requires new modalities of care.”

The post Intuitive Surgical wins FDA clearance for robotic-assisted lung biopsy system appeared first on MassDevice.

Intuitive Surgical expands Silicon Valley footprint

Intuitive Surgical

Intuitive Surgical (NSDQ:ISRG) has leased two new buildings in Santa Clara, Calif., near its Sunnyvale-based headquarters, as it looks to expand its Silicon Valley footprint, according to a Mercury News report.

Each new building clocks in at roughly 105,000 square feet, and construction work has already begun on both buildings, according to the report.

“We have engineering, manufacturing, and administrative operations in Sunnyvale. This location has served us well as our headquarters and we have attracted exceptional employees. Our business has grown significantly over the past several years, necessitating expansion in locations worldwide, including Sunnyvale,” Intuitive Surgical media relations director Peper Long told the Mercury News. “The facilities at 3410 and 3420 Central Expressway are within walking distance of our core campus and provide the expansion space we need.”

Last week, Intuitive Surgical said that it is expanding its share repurchasing program to $2 billion.

The post Intuitive Surgical expands Silicon Valley footprint appeared first on MassDevice.

Intuitive Surgical expands share buyback program to $2B

Intuitive Surgical (NSDQ:ISRG) said yesterday that it is expanding its share repurchasing program to $2 billion.

The Sunnyvale, Calif.-based company said that the increase is an aggregate and includes amounts remaining under previous authorizations, according to an SEC filing

Intuitive surgical said that it expects to fund the repurchase program through cash and investments, and that the program “does not obligate the company to acquire any particular amount of common stock,” according to the filing.

Shares in Intuitive Surgical are up approximately 0.3% today, at $525.42 as of 11:10 a.m. EST.

Late last month, the medical robotics giant saw share prices fall after it released fourth quarter and fiscal year 2018 earnings that beat sales expectations but fell just short of earnings per share consensus on Wall Street.

The post Intuitive Surgical expands share buyback program to $2B appeared first on MassDevice.

Intuitive Surgical shares dip on mixed-bag Q4, FY2018 earnings release

Shares in Intuitive Surgical (NSDQ:ISRG) have fallen slightly in after-hours trading after the robotic surgical maker released fourth quarter and fiscal year 2018 earnings that beat sales expectations but fell just short of earnings per share consensus on Wall Street.

The Sunnyvale, Calif.-based company posted profits of $292.5 million, or $2.45 per share, on sales of approximately $1.05 billion for the three months ended December 31, seeing a massive swing from the red on the bottom line while sales grew 17.3% compared with the same period during the previous fiscal year.

During the fourth quarter, Intuitive Surgical reported that its systems revenue increased approximately 20%, while its instrument and accessory revenue grew approximately 18%, primarily driven by an increase in da Vinci procedure volume.

The company said that it shipped 290 da Vinci systems during the fourth quarter, up from 216 units shipped in the fourth quarter of 2017. The shipments included 84 units under operating lease and usage-based arrangements, up from 40 in the fourth quarter of 2017, according to the company’s earnings release.

Adjusted to exclude one-time items, earnings per share for the fourth quarter were $2.96, just behind the $3.07 consensus on Wall Street where analysts were looking for sales of $1.04 billion, which the company handily topped.

For the full fiscal year, Intuitive Surgical posted profits of approximately $1.13 billion, or $9.49 per share, on sales of approximately $3.72 billion, for bottom-line growth of 68.1% while sales grew 18.7% when compared to the previous year.

After adjusting to exclude one-time items, earnings per share were $10.99, just behind the $11.10 consensus on Wall Street, where analysts expected to see sales of $3.71 billion, which the company beat.

Shares in Intuitive Surgical have fallen approximately 4.3% today in after-hours trading, at $513 as of 5:16 p.m. EST.

Last December, CEO Gary Guthart spoke at DeviceTalks West in Orange County, Calif. on how his company stays innovative and continues to lead the surgical robotics field.

The post Intuitive Surgical shares dip on mixed-bag Q4, FY2018 earnings release appeared first on MassDevice.

JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019

JenaValve

JenaValve Technology said today that it named former ReVision Optics prez & CEO John Kilcoyne as its new chief executive officer, effective immediately, replacing Dr. Victoria Carr-Brendell, who has taken up an executive leadership position with Sonova Holding AG (SIX:SOON).

Prior to his time at ReVision Optics, Kilcoyne served as prez & CEO at Micrus Endovascular where he led the company through an initial public offering in 2005 and an acquisition by Johnson & Johnson in 2010. He has also held positions at Solace Therapeutics and Endonetics, Irvine, Calif.-based JenaValve said.

“I am pleased to have the opportunity to lead JenaValve, and I look forward to working with the team to bring new, innovative solutions to the transcatheter valve market. Data from past and ongoing trials clearly indicate the strong potential that the JenaValve technology can greatly improve the health of patients with aortic stenosis and aortic regurgitation. Our focus in 2019 is on completing the current clinical development programs and gaining commercial readiness for potential international launch activities under CE mark and U.S. Humanitarian Device Exemption regulatory processes,” Kilcoyne said in a prepared statement.

“I am thrilled that John Kilcoyne has agreed to lead our company. In John, we have identified a dynamic and seasoned executive with an extensive background in driving medical businesses through the key stages of growth and value generation. His proven leadership qualities will be instrumental in bringing our breakthrough technology to the market and success for all stakeholders. Victoria made many significant contributions during her tenure at JenaValve. We are grateful for her contributions and wish her well in her future endeavors,” board chair Jan Keltjens said in prepared remarks.

Sonova said last November that Carr-Brendel was joining the company as cochlear implants group VP and advanced bionics prez. Prior to joining JenaValve, Carr-Brendel served as Boston Scientific peripheral interventions franchise general manager, the company said.

Sonova said that Carr-Brendel officially joined the advanced bionics division last December 3, and that they would take full responsibility as prez on April 1, according to a press release.

 Endologix taps Zehren as new chief commercial officer

Endologix (NSDQ:ELGX) said last week that it appointed John Zehren as its new chief commercial officer, effective January 7.

Prior to joining Irvine, Calif.-based Endologix, Zehren served as Medtronic neurovascular division Americas sales VP and a senior member of the company’s neurovascular management board. Zehren also held sales VP positions with Covidien and ev3, and held leadership positions with Edwards Lifesciences.

“We are proud to welcome John, an accomplished commercial medical device leader, to our executive team. He has demonstrated a strong track record of achievement, consistently implementing successful commercial strategies that resulted in impressive growth, share gains, and customer loyalty. We believe John will play a critical role in strengthening and extending Endologix’s customer partnerships and commercial execution, while leading the company’s global go-to-market strategy for our AFX2, Ovation, and Nellix platforms,” CEO John Onopchenko said in a prepared statement.

“I’m excited to join an organization that has driven so much innovation in the cardiovascular segment and believe that we have an excellent opportunity to strengthen our customer partnerships and secure increased market share and procedural growth around the globe. I look forward to working with the Endologix team to drive commercial excellence and bring our differentiated, life-saving technology to more patients in need,” Zehren said in a press release.

Read more

 Outset Medical appoints Aragon as CMO, Porter as people ops VP

Outset Medical said today that it appointed Dr. Michael Aragon as its new chief medical officer and Stacey Porter as its people operations VP.

Prior to joining San Jose, Calif.-based Outset Medical, Aragorn served as a medical director for DaVita and U.S. Renal Care and was a founding partner and president of the North Texas Kidney Consultants. He currently serves as board chair for the End-Stage Renal Disease Network of Texas, Outset Medical said.

“The leadership team at Outset is dedicated to improving care for patients with end-stage kidney disease with a simplified, more cost-effective dialysis solution. Having served hundreds of patients firsthand for more than a decade, I’ve seen the burden of dialysis on patients, their families, and their healthcare providers. I share Outset’s passion for bringing much-needed innovation to the industry, and look forward to helping lead the organization as it transforms the dialysis experience,” Aragon said in a press release.

Porter has more than 18 years of leadership development and organizational learning implementation, and previously served as head of global talent development fo Intuitive Surgical. Prior to joining Intuitive, she held leadership roles at VMware and Roche.

“There are more than 500,000 end-stage renal disease patients in the United States whose lives depend upon dialysis and the companies working to improve and expand treatment options. I am excited to join the exceptional team that Outset has already built, and look forward to helping contribute to the growth and development of this talented and committed group,” Porter said in a prepared statement.

“We are thrilled to welcome Michael and Stacey to the Outset Medical team. Both are outstanding leaders and experts in their fields, and will play an instrumental role in helping us deliver on our mission to improve global dialysis care and offer a better experience for providers and patients. Michael joins an esteemed group of nephrology experts involved with Outset including Dr. Glenn Chertow, Chief, Division of Nephrology, Stanford University School of Medicine; Dr. Sarah Prichard, an academic nephrologist and former medical affairs and R&D leader at Baxter; and Dr. Luis Alvarez, Chair of Nephrology, Palo Alto Medical Foundation, Sutter Health, and Outset’s chief advisor for technology and innovation,” CEO Leslie Trigg said in a prepared release.

Read more

 Xtant Medical taps Berlin as COO, VP

Xtant Medical (NYSE:XTNT) said last week it tapped Ronald Berlin as its new COO and VP, effective January 1.

Prior to joining Belgrade, Mont.-based Xtant Medical, Berlin served as global ops VP at CoorsTek Medical. He has also held leadership positions with Integra LifeSciences and Stryker, the company said.

“Ron is an accomplished healthcare executive with significant operations and quality management expertise and we are pleased that he has joined our executive management team. In addition to the operational leadership he will provide to the organization, he is a strong strategic, cross-functional leader. His appointment continues our commitment to building a highly skilled management team,” interim CEO Michael Mainelli said in a press release.

“I’m particularly pleased to be joining this exceptional, newly appointed executive leadership team and look forward to helping the Company continue to transform its business and drive shareholder value,” Berlin said in a prepared statement.

Read more

 Digirad adds interim CFO duties to COO Noble

Digirad Corp. (NSDQ:DRAD) said yesterday that its current chief operating officer David Noble will take on the role of interim CFO for the company, effective today.

Noble, a veteran of finance and business building of over 20 years, previously held financial and management roles with HSBC and Lehman Brothers, the Suwanee, Ga.-based company said in an SEC filing.

Read more

The post JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019 appeared first on MassDevice.

Intuitive Surgical rises on Q4, 2018 prelim beats

Intuitive Surgical (NSDQ:ISRG) shares are up today after the robot-assisted surgery pioneer said its fourth-quarter and 2018 sales would top the consensus forecast on Wall Street, as procedure volumes and shipments of its da Vinci device both surged.

Sunnyvale, Calif.-based Intuitive said it expects to post Q4 sales of $1.05 billion and annual sales of $3.72 billion, compared with The Street’s outlook for $1.03 billion and $3.71 billion, respectively. Full results are slated to be released Jan. 24, the company said.

Procedure volumes spiked 19% during the fourth quarter and rose 18% for the full year, topping the 1 million mark for the first time, Intuitive said, noting that shipments rose 35.4% to 926 during 2018.

“We are pleased with our fourth-quarter procedure growth, system placements and the financial results that follow. We are committed to advancing intelligent minimally invasive care through the combination of human understanding, smart systems and instruments, and digital insights,” president & CEO Gary Guthart said in prepared remarks.

Intuitive also said that its joint venture with Shanghai Fosun Pharmaceutical (SHA:600196) to develop robotic-assisted catheter-based medical devices launched direct operations for da Vinci this month; direct operations in Taiwain kicked off in December.

The company also said it put $25 million into its newly established Intuitive Foundation during the fourth quarter, saying the foundations mission is to “reduce the global burden of disease and suffering through research, education, and philanthropy aimed at better outcomes for patients around the globe.”

ISRG shares were up 5.6% to $509.84 apiece today in mid-day trading.

The post Intuitive Surgical rises on Q4, 2018 prelim beats appeared first on MassDevice.

Here’s how Intuitive Surgical is innovating to stay competitive

Intuitive Surgical da Vinci SP

During his DeviceTalks West keynote, Intuitive Surgical CEO Gary Guthart touted the da Vinci SP robot-assisted surgery system and the expanded clearance Intuitive would like to achieve for the single-port device. [Image courtesy of Intuitive Surgical]

Intuitive Surgical (NSDQ:ISRG) isn’t resting on its laurels when it comes to the surgical robotics field that it dominates. The Sunnyvale, Calif.­–based company is seeking to stay competitive through technologies including computer-controlled navigated robotic catheters, contrast agents to improve imaging during procedures, and intelligent surgical interfaces.

That was a big message that hundreds of attendees heard during Intuitive Surgical CEO Gary Guthart’s evening keynote discussion on Dec. 11 at DeviceTalks West in Orange County, Calif.

“Payers are constraining total costs per treatment episode, so we have to do all of this innovation and lower the total cost to treat per patient episode,” Guthart said. “There are a bunch of people who think that the way to do that is to make things as cheaply as possible. Product cost matters, but innovation is going to be a lot more important.”

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

(DeviceTalks returns June 5–6, 2019 in Boston.)

The post Here’s how Intuitive Surgical is innovating to stay competitive appeared first on MassDevice.

10 of the best performing medical device stocks of 2018

(Image from Unsplash)

Nearly half of the world’s 100 largest medical device companies saw their stock prices increase by double-digit percentages during the first 10 months of 2018, according to a Medical Design & Outsourcing analysis.

The feat is even more amazing considering that October was a rocky month for the Dow Jones Industrial Average, with the year’s gains mostly erased amid worries over Federal Reserve interest rate hikes and the U.S.-China trade war.

Medical device companies were able to buck the trend thanks to a number of different factors, including strong product launches, positive clinical trial results, new markets opening up or internal changes.

Being innovative mattered, too. It’s not too surprising that some medical device companies spending a large amount on R&D compared to revenue – including Dexcom, Abiomed, Atricure, Edwards Lifesciences and Insulet – saw their stock prices skyrocket as they marketed innovative devices in fields including diabetes management and cardiology.

Here are 10 of 2018’s top performers and a bit about what each has accomplished so far this year.

Next>>

Managing editor Chris Newmarker contributed to this report. 

The post 10 of the best performing medical device stocks of 2018 appeared first on MassDevice.