Corindus touts first Japanese CorPath GRX procedures

Corindus Vascular RoboticsCorindus 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.

Stryker wins FDA PMA, launches Lifepak CR2 AED

Stryker

Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system.

The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said.

The Lifepak CR2 AED also features a child mode button to reduce defibrillation energy for pediatric patients and an optional bilingual feature.

The system can be connected to the LifelinkCentral AED program manager to allow an organizations AED manager to remotely monitor and manage the device to improve readiness, Stryker said.

“In order to save more lives from sudden cardiac arrest, we must save time. The Lifepak CR2 is designed to help rescuers provide higher quality CPR and to provide the fastest first shock when defibrillation is needed. Everything about it is designed to increase user confidence. The Lifepak CR2 harnesses the benefits of connectivity to provide a foundation for better care throughout the entire chain of survival and to simplify AED program management for our customers,” Stryker emergency care public access GM Ryan Landon said in a press release.

The Lifepak CR2 was previously released in Europe and Canada in 2017 and in Japan in 2018, Stryker said.

In March, Stryker said that it put $220 million on the table for OrthoSpace and its InSpace rotator cuff repair device.

Biotronik launches PK Papyrus covered coronary stent

Biotronik's PK Papyrus stentBiotronik said today that it’s launching the PK Papyrus covered coronary stent system for acute coronary artery perforations in the U.S.

When the FDA granted 510(k) clearance last September, the federal safety watchdog touted it as the first such device to win clearance for that indication in 17 years. About 1% of the 800,000 PCIs performed in the U.S. require a covered stent, according to Lake Oswego, N.Y.-based Biotronik, qualifying PK Papyrus for a humanitarian device exemption.

“The availability of PK Papyrus marks a long-overdue advancement in the field of interventional cardiology,” president Ryan Walters said in prepared remarks. “Clinicians can now rely on a low-profile covered stent during critical cardiac emergencies. In situations where every second counts, physicians can trust PK Papyrus to deliver quickly. Biotronik’s covered stent is designed to save more lives and to help avoid emergency bypass surgeries, which come with increased risk for patients and can be costly for hospitals. This is innovation that matters for hospital administrators, physicians and their patients, who deserve the best outcomes.”

Angel Medical’s Guardian implantable heart monitor fails on efficacy endpoint

AngelMed GuardianA clinical trial of the Guardian implantable heart attack monitor made by Angel Medical Systems failed to meet its efficacy endpoint, but suggested that the device could be used to help detect “silent” heart attacks.

Wilmington, Del.-based AngelMed won FDA clearance a year ago for the Guardian device for patients with prior acute coronary syndrome events including myocardial infarctions or unstable angina at high risk for further ACS events. Its 907-patient Alerts study randomized patients implanted with Guardian to either six months with the alert function active for the treatment group or six months without activation for the control arm; both groups had the alert function activated after the six-month randomized stage.

The primary efficacy endpoint, a confirmed occlusive event within 7 days, was not significantly reduced for the treatment arm at 3.8%, compared with 4.9% for the control arm. The primary safety endpoint was met a 96.7% rate of freedom from device-related complications, according to the study, published in the Journal of the American College of Cardiology and presented last month at the annual Cardiovascular Research Technologies conference in Washington, D.C., by principal investigator Dr. Michael Gibson.

However, the Guardian device cut detection-to-arrival-time from 30.6 hours to 51 minutes and an expanded analysis showed a higher predictive value and lower false positive rate for the treated cohort.

“Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events,” wrote the study’s authors, all of whom received research grants from AngelMed, including one who owns a stake in the company.

“As Dr. Gibson discussed in his presentation, the Guardian has shown that it can get patients to the ER even if they do not have symptoms of ACS events, including silent heart attacks. This is a first-ever capability for any product and allows the Guardian to fill an unmet medical need by providing more effective diagnosis of a life-threatening condition compared to relying on patient symptoms alone,” AngelMed CEO David Fischell said in prepared remarks.

Last last month the company emerged from Chapter 11 bankruptcy protection with a $10 million Series A round.

Silk Road Medical clears $109m in IPO

Silk Road MedicalSilk Road Medical (NSDQ:SILK) said yesterday that it cleared just more than $109 million in its initial public offering, including a fully subscribed underwriters option.

The $20-per-share flotation grossed $120 million, Sunnyvale, Calif.-based Silk Road said. The company is developing a neuroprotection and stent system called Enroute as an aid to transcarotid artery revascularization procedures. Silk Road’s estimated net proceeds of $109.1 million are earmarked for sales force expansion, new clinical trials, increasing its international footprint and potentially for acquisitions.

president & CEO Erica Rogers told MassDevice.com last week that Enroute is designed to be a less-invasive alternative to carotid endarterectomy. It’s engineered to temporarily reverse blood flow during shunting to prevent debris from entering the brain, Rogers told us.

In their first day of trading April 4, SILK shares gained 80.9% on the IPO price, opening at $33.15 apiece and rising as high as $39.51 before closing at $36.18 each. The stock closed down -2.3% at $34.99 per share yesterday.

Mick Jagger is giving TAVR a boost: Here’s how

Mick Jagger TAVR

Mick Jagger during a concert in Warsaw, Poland in 2018 [Image by Jerzy Bednarski – Own work, CC BY-SA 4.0]

A successful transcatheter aortic valve replacement (TAVR) recovery for rock icon Mick Jagger could be good news for companies such as Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) that make devices for the procedure, according to analysts following the medical device industry.

The Rolling Stone frontman tweeted Friday that he was feeling better and on the mend after undergoing the procedure at a New York hospital.

“We think Mick Jagger’s TAVR procedure will likely raise awareness of aortic stenosis and potentially lead to more TAVR procedures which should benefit the TAVR manufacturers,” Wells Fargo analysts Larry Biegelsen, Lei Huang, Adam C. Maeder, Shagun Singh said in an equity research note dated yesterday.

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

Tioga Medical raises $15m to support transcath mitral, tricuspid valve tech

Tioga Medical

Newly formed Shifamed portfolio company Tioga Medical said today that it closed a $15 million Series A preferred stock financing round to support its transcatheter mitral and tricuspid valve replacement technology.

The Campbell, Calif.-based company said that it is developing novel transcatheter valve replacement technology intended to be simpler and less invasive than current mitral and tricuspid valve replacement approaches.

Tioga Medical will initially focus on technology for mitral valve replacement, stating that there is a “significant clinical need for less invasive, transcatheter approaches for mitral valve replacement.”

“We are extremely pleased to close this round of financing with such strong support from our investors. This round allows us to build out a world class team and dramatically accelerate the progress of our novel mitral valve and delivery system before we leverage the technology for the tricuspid application,” prez & CEO Mike Dineen said in a prepared statement.

The Series A round was led by The Capital Partnership and joined by Cormorant Healthcare Fund, AMED Ventures and Shangby Capital. Tioga Medical said that funds from the round will be used to advance its pre-clinical and clinical development programs.

“The proprietary Tioga technology represents a truly innovative solution to a difficult clinical problem in the structural heart space. TCP is excited to partner with a team with a strong track record of innovative medtech solutions. We believe this combination positions Tioga as an important, up-and-coming player in the mitral and tricuspid valve markets,” TCP private investments head Casey Gordon said in a press release.

Money in the round came from 23 unnamed sources, with the first date of sale noted as having occurred on March 12, according to a recently posted SEC filing.

TherOx wins FDA approval for SuperSaturated Oxygen therapy

TherOxTherOx said today that it won pre-market approval from the FDA for its SuperSaturated Oxygen Therapy system for acute myocardial infarction.

Irvine, Calif.-based TherOx touted the PMA as the first heart attack treatment approved to reduce infarct size since the federal safety watchdog OK’d percutaneous coronary interventions.

Indicated for patients suffering from left anterior descending ST-elevation myocardial infarction – the most deadly form of heart attack, known colloquially as the “widowmaker” – within six hours of onset and after stenting, SSO2 therapy delivers hyperbaric levels of oxygen directly to heart muscle tissue that’s denied blood flow during the attack.

“We have repeatedly demonstrated that SSO2 therapy significantly reduces infarct size among patients who suffer from large anterior AMIs, which are the most serious heart attacks,” president & CEO Kevin Larkin said in prepared remarks. “This FDA approval enables interventional cardiologists to provide the most advanced care available to further reduce infarct size, prevent heart failure and ultimately save lives.”

“Even after angioplasty with stenting, many heart attack patients suffer from irreversible damage to the heart muscle, which carries a poor prognosis in terms of mortality and the potential for future heart failure,” added Dr. Gregg Stone of New York City’s Columbia University Medical Center. “SuperSaturated Oxygen is the only therapy shown in a pivotal randomized trial to reduce infarct size in patients with large anterior myocardial infarction, offering the potential to further improve outcomes in these high-risk patients despite successful primary angioplasty.”

TherOx said a pivotal trial showed a 26% relative reduction in infarct size compared to PCI alone and left ventricular stability at 30 days with no adverse infarct enlargement.

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.

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

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Tricuspid valve repair device maker CroíValve raises $4m

CroíValve

Early stage tricuspid valve repair device developer CroíValve has raised approximately $3.6 million (EU €3.2 million) in an oversubscribed seed financing round, according to a report from the Irish Times.

CroíValve is developing a novel percutaneous solution intended to treat tricuspid regurgitation that seals the central gap between the native valve leaflets to prevent regurgitation, according to the company’s website.

The funding round was led by the business angel network HBAN and joined by Atlantic Bridge University Fund, Enterprise Ireland, Seán O’Sullivan’s SOSV and a total of 48 angel investors, according to the report.

CroíValve said it plans to use funds raised in the round to support continued development of the device.

“We welcome the investors’ support in accelerating our development efforts and look forward to working together to bring this exciting technology to patients. In doing so we are currently building our team, particularly in the area of R&D, and by year-end 2019 we will have grown to a company of 10,” founder Dr. Lucy O’Keeffe said, according to the Irish Times.

In connection with the funding round, former Boston Scientific exec and HBAN syndicate member Dr. Bernard Collins was named as board chair, according to the report.

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