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.”

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ReWalk Robotics files for exoskeleton suit clearance

 

ReWalk Robotics’ exo-suit designed for stroke rehabilitation.

ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation.

The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical trial involving 44 patients at five rehabilitation centers in the U.S.

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

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Corindus asks FDA for expanded neurosurgery indication for CorPath GRX

Corindus Vascular Robotics

Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions.

The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year.

“The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics. Applying the benefits of robotic precision to neurovascular intervention, while building a wealth of clinical knowledge and expertise, are key to preparing for a future of remote stroke treatment,” chief medical officer Dr. Aquilla Turk said in a prepared release.

Corindus touted that if it receives the clearance, the CorPath GRX system would be the world’s first and only robotic platform indicated for all three indications.

“An expansion of CorPath GRX to treat neurovascular conditions would represent a major stepping stone towards our goal of revolutionizing stroke treatment. We believe that our current robotic platform will bring benefits to neurovascular procedures today and we will leverage our recent achievements in telerobotics and strong focus on technology development to build a remote stroke solution to tackle the challenge of access to care. This would extend the reach of highly-skilled specialists across the globe by granting remote access to patients suffering from life-altering diseases where access to care is limited and time to treatment is paramount,” prez & CEO Mark Toland said in a prepared statement.

Last December, Corindus touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India.

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Titan Medical hopeful for Q4 FDA IDE trial launch for Sport robotic platform

Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said late yesterday that it is hoping to launch an FDA investigational device exemption trial of its Sport robotic surgery platform by the fourth quarter of this year.

The news came as part of the Toronto-based company’s 2018 earnings report, with the robotic surgical company saying that it is hopeful it will finish verification and validation testing followed by design freeze and animal and cadaver studies to support regulatory clearance filings during the first half of 2019.

Following that testing, Titan Medical said it hopes to submit an IDE study application to the FDA during the first half of this year, with a study launch following during the fourth quarter. The company added that it hopes to submit both a 510(k) premarket notification and technical files to support CE Mark approval in the European Union by the end of the year.

In its earnings report, Titan Medical saw losses shrink 32.6% from approximately $33.6 million in 2017 to approximately $22.6 million in 2018. Research and development expenses ballooned, however, rising 60.7% from approximately $12.9 million in 2017 to approximately $32.9 million in 2018.

“2018 was an exceptionally busy and productive year for Titan Medical as we achieved all milestones related to the development of our Sport single-port robotic surgery system. I want to congratulate the Titan Medical team and our business partners for their dedication as we continue our important work toward commercialization. By our internal estimates, we believe there is an opportunity for us to access an unaddressed U.S. market that potentially may include more than $12 billion in capital equipment revenue and more than $3 billion in associated annual recurring revenue, including smaller hospitals and the underserved ambulatory surgery center market segment. During the fourth quarter we completed the system engineering confidence build for our next-generation SPORT Surgical System, including a new camera system and design enhancements to the surgeon workstation and the patient cart, the two primary components of the system. The enhancements reflect our preclinical experience with expert robotic surgeons. We ended the year gaining clarity from the U.S. Food and Drug Administration on the regulatory pathway for the Sport system. During the second quarter, we expect to begin conducting the requisite animal studies that precede human studies. During the second half of 2019 we plan to complete the required human confirmatory studies under an Investigational Device Exemption, or IDE, in support of a 510(k) filing by the end of the year. We also expect to file for the CE mark by year-end 2019,” CEO David McNally said in a press release.

Last month, Titan Medical said that it completed an initial build of its Sport single-port robotic surgery system, paving the way for future development of the platform.

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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.

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Vicarious Surgical raises $10m more

Vicarious Surgical has raised another $10 million for the virtual reality-augmented robot-assisted surgery platform it’s developing, according to an SEC filing.

The latest round of funding follows on the heels of a  nearly $17 million round announced in April 2018. Charlestown, Mass.-based Vicarious first reported a $2.4 million raise in January 2016 and another $800,000 in October of that year.

Vicarious has said its device “combines virtual reality with proprietary human-like surgical robotics to enable surgeons to perform minimally invasive surgery through a single micro-incision,” claiming to have achieved “the goal of surgical robotics since the field’s inception – to shrink the surgeon and put them inside the patient.”

Its website lists Khosla Ventures, AME Cloud Ventures, and Innovation Endeavors as investors. The company noted that six investors contributed to the current round, but did not identify them.

 

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Medtronic touts U.S. launch of Mazor X Stealth spinal robot-assisted surgery device

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S., touting its recent use in its first commercial procedures.

The first uses of the system took place at Louisville, Ky.’s Norton Healthcare and Reston, Va.’s Reston Hospital Center, the Fridley, Minn.-based medtech giant said.

“The marriage of robotics and navigation represents the future of computerized planning and execution in spine surgery. Robotics and navigation have both been shown to improve accuracy and precision in spine surgery. The Mazor X Stealth edition is a revolutionary new technology that uses cutting-edge software to plan the surgical procedure, then uses a robotic arm to guide implants and instruments through the steps of the surgical procedure with precision, while simultaneously using real-time imaging feedback to ensure the plan is being carried out as desired,” Dr. Christopher Good of Reston Hospital Center and The Virginia Spine Institute said in prepared remarks.

The newly launched spinal robotic platform incorporates Medtronic’s Stealth software technology into their recently acquired Mazor Robotic’s Mazor X robotic-assisted surgical platform, the company said.

The addition of Stealth technology is intended to improve workflow predictability through the use of real-time image guidance, visualization and navigation using 3D planning and information systems, the company added.

“It is rare that huge sectors of technology such as robotics and navigation merge into a sole platform as found in the Mazor X Stealth edition. Combined, these may provide more predictable and reliable execution of our procedure workflows. Computerized surgical planning, 3-D assessment of spine anatomy, robotic guidance and live navigation feedback are designed to provide a higher degree of accuracy throughout the surgical procedure,” Dr. Jeffrey Gum of Norton Leatherman Spine said in a prepared statement.

The system won FDA clearance in November and is now available in the U.S. Medtronic said it plans to launch the system in key regions throughout 2019.

“As part of our Surgical Synergy strategy, we believe Mazor X Stealth edition will accelerate the advancement and adoption of robotic-assisted and navigated surgical technologies in spine. Medtronic is committed to transforming the future of spine care by offering procedural solutions that integrate implants, biologics and enabling technologies like navigation, 3-D imaging, robotics and powered surgical tools,” Medtronic restorative therapies group prez Geoff Martha said in a press release.

The product is the first to come out of Medtronic’s acquisition of Mazor, originally announced in September and closed late last month.

The world’s largest medical device maker has held a position in Mazor, which makes the Mazor X guidance system and the Renaissance robot-assisted spine surgery platform, since May 2016. Last September they closed the third, $40 million tranche of the investment, giving Medtronic a 10.6% stake it paid $72 million for.

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Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system

Zimmer Biomet logo

Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its Rosa Knee robotically-assisted total knee replacement surgery platform.

The newly cleared Rosa Knee system includes 3D pre-operative planning tools and real-time intraoperative data on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.-based company said.

“Complementing the skill and expertise of the surgeon with Rosa Knee’s robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency. Rosa Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion,” Dr. Christopher Cannova of the Washington Joint Institute at OrthoBethesda said in a prepared statement.

Zimmer Biomet said that the Rosa Knee also features its proprietary X-Atlas imaging protocol, which provides X-ray based preoperative imaging to create a 3D model and plan of the patient’s bone anatomy.

“We are excited for the launch of Rosa Knee, which brings together Zimmer Biomet’s robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients. Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes,” orthopedics group prez Ivan Tornos said in a press release.

In November, Zimmer Biomet said that it won FDA 510(k) clearance for its Persona revision knee implant.

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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.

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J&J may nab surgical robotics company Auris Health

Johnson & JohnsonJohnson & Johnson (NYSE:JNJ) intends to acquire surgical robotics company Auris Health, according to a report by Bloomberg News.

In May 2018, Auris inked an agreement with J&J’s division Ethicon’s NeuWave Medical subsidiary to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions. J&J has been working with Alphabet‘s (NSDQ:GOOGLVerily Life Sciences on Verb Surgical’s prototype robot-assisted surgery platform.

J&J wants to spend more for Auris than the smaller company’s $2 billion valuation from its latest funding round, the Bloomberg report said, citing anonymous sources. Redwood City, Calif.-based Auris closed on a $220 million equity financing round in November to help support its next-generation Monarch robotic interventional platform. The funding round brings the total raised for the Monarch platform up to $700 million, Auris Health said.

The Monarch platform has FDA clearance for diagnostic and therapeutic bronchoscopic procedures. The system features a controller interface for navigating the integrated flexible robotic endoscope into the periphery of the lung and combines traditional endoscopic views with computer-assisted navigation based on 3D patient models, the company said.

Auris’ system uses a game-like controller that allows for more direct control than existing one-handed interfaces to maneuver the endoscope.

Formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, closely held Auris bought Hansen Medical, which Moll co-founded, for $80 million in 2016.

Under the Auris-NeuWave agreement, both companies are helping to develop an integrated system for robotic control, navigation and application of bronchoscope-delivered microwave ablation. The bronchoscope in development will be equipped with a small camera and accessory channel to allow tools to enter the lungs through the mouth, Auris said in May.

Yesterday, J&J reported a return to black ink for the fourth quarter and set its financial forecast for the rest of the year. The New Brunswick, N.J.-based healthcare giant posted profits of $3.04 billion, or $1.12 per share, on sales of $20.39 billion for the quarter, for a 1.0% top-line gain over Q4 2017, when J&J posted losses of -$10.71 billion.

Auris declined to comment on the possible acquisition. J&J did not respond to a request for comment. J&J closed the $2.1 billion sale of its LifeScan blood glucose monitoring subsidiary to private equity player Platinum Equity in October 2018.

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