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.

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.”

Seisa Medical acquires stent & delivery system maker Burpee MedSystems

Seisa Medical

Seisa Medical said today that it acquired stent and delivery device manufacturer Burpee MedSystems for an undisclosed amount.

New Jersey-based Burpee MedSystems was founded in 1998 and uses laser machining, surface finishing, nitinol forming and shaping and welding to create stents and delivery systems, El Paso, Texas-based Seisa Medical said.

“We are thrilled to be joining Seisa as it gives Burpee MedSystems the global infrastructure we’ve been aiming for to expand our offerings and capabilities to the market,” Burpee MedSystems CEO Janet Burpee said in a prepared statement.

Janet and co-founder Steve Burpee will continue to support Burpee MedSystems and will retain majority ownership of medical device incubator and holding company Tinker Med, which was previously wholly owned by Burpee MedSystems.

Seisa said that it funded the transaction through its $52 million senior secured credit facility, and added that it is actively pursuing prudent and accretive acquisitions.

“This acquisition demonstrates Seisa’s commitment to investing in vertical capabilities to create end-to-end solutions that deliver value to our customers. The marriage between Seisa’s high-volume production of FDA Class II and Class III devices with Burpee MedSystems’ mastery in the manufacture of complex stents, delivery systems, and components will provide a scalable one-stop-shop for customers focused on the high-growth markets for implantable stents and their delivery systems. We are excited to welcome the Burpee team to Seisa. Together we offer not only a compelling offering for strategic outsourcing solutions in the medical device market, but also provide all our employees more opportunities globally as well,” Seisa founder & CEO Julio Chiu said in a press release.

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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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1st U.S. patient treated with Cook Medical endovascular aortic dissection system

Cook Medical’s Zenith endovascular dissection system consists of two stents to treat a tear within the aorta. (Image from Cook Medical)

Cook Medical said it has launched its Zenith dissection endovascular system, recently approved by the FDA. The first patient was treated with the system at Cooper University Health Care in Camden, N.J., according to the company.

The Zenith system was designed to provide physicians with a less-invasive alternative to open surgery for repair of Type B dissections of the descending thoracic aorta. Zenith consists of a proximal stent-graft component and a distal bare-stent component.

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

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FDA ramps up scrutiny of materials in medical devices

(Image by Michael Longmire on Unsplash)

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

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

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FDA approves BD’s Venovo venous stent

Becton Dickinson's Venovo stentBecton Dickinson & Co. (NYSE:BDX) said today that the FDA granted pre-market approval for its Venovo stent for treating iliofemoral venous occlusive disease.

Franklin Lakes, N.J.-based BD touted Venovo as the first on the U.S. market approved to treat obstructed blood flow in the iliac and femoral veins.

“The FDA pre-market approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an under-recognized condition,” peripheral intervention president Steve Williamson said in prepared remarks. “We designed the Venovo venous stent in collaboration with clinicians to enable them to treat both post-thrombotic and non-thrombotic lesions. Clinicians will now have access to the broadest range of stent sizes in the U.S. for these difficult-to-treat lesions.”

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” added Dr. Michael Dake of the University of Arizona, who was principal investigator for the Vernacular investigational device exemption trial. “Most importantly, it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.”

BD said one-year results from the 170-patient Vernacular study showed a weighted primary patency rate of 88.3%, a 96.9% patency rate in non-thrombotic lesions and an 81.3% patency rate in post-thrombotic lesions; the performance goal was 74%. Venovo-treated patients reported a statistically significant reduction in pain symptoms and improvement in quality of life, the company said. The stent was deployed successfully to the target lesion and showed adequate coverage in all cases and there were no fractures as of the 12-month mark.

Venovo is on the market in the U.S., Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan, BD said.

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Stents, knee implants undergird Trump’s new trade war with India

IndiaThe Trump administration yesterday opened hostilities in a pair of new trade wars, using India’s price caps on coronary stents and knee implants as the centerpiece of the new policy there.

The White House said it plans to end India’s preferential trade status in 60 days under the Generalized System of Preference.

“India’s termination from GSP follows its failure to provide the United States with assurances that it will provide equitable and reasonable access to its markets in numerous sectors,” U.S. trade representative Robert Lighthizer wrote yesterday, rebuffing India’s proposal to open up its agriculture market to U.S. firms. “Despite intensive engagement, India has failed to take the necessary steps to meet the GSP criterion.”

Caps enacted by India’s National Pharmaceutical Pricing Authority on knee implants and cardiac stents are at the core of the dispute, having caused major medtech players to seek to withdraw their devices from the market there. In April 2017, the NPPA rejected applications from Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) to pull their respective Resolute Onyx and Absorb stents (Abbott has since taken Absorb off the global market, citing lackluster sales). The NPPA is already considering further caps for other medical devices.

At some 2,000 products worth a collective $5.6 billion, or roughly 12% of exports to the U.S., India is the largest trade partner under the GSP. Removing protections from those products would subject them to higher tariffs, but government officials in India estimate that losing GSP status would amount to only $200 million to $250 million in increased tariffs, according to the Times of India.

“We just have to take it on the chin and move on,” an anonymous official told the newspaper.

Lighthizer said the U.S. also plans to withdraw GSP status from Turkey, following “a finding that it is sufficiently economically developed and should no longer benefit from preferential market access to the United States market.”

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Medtronic wins expanded FDA indication for Resolute DES

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion.

The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said.

Read the whole story on our sister site, Drug Delivery Business News

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Biotronik wins FDA nod for Orsiro DES

Biotronik logo

Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.

The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly lower rate for target lesion failure and target vessel myocardial infarction at 12 months as compared to Xience in a large, complex patient audience.

Read the whole story on our sister site, Drug Delivery Business News

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