Medtronic wins EU nod for less-invasive HVAD implant procedure

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August.

The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related blood transfusions.

The newly cleared procedure could potentially reduce the development of right heart failure and could lead to shorter hospital stays, along with allowing for the area around the heart to remain largely intact to potentially preserve the sternum for future procedures or heart transplants, the company said.

“The HVAD System’s small size makes it well-suited for routine thoracotomy implantation. This less-invasive implant procedure potentially enables faster patient recovery compared to the traditional approach, which may help improve patient outcomes,” Dr. Jan Schmitto of Germany’s Hannover Medical School, who helped develop the new procedure, said in prepared remarks.

The company said it is currently performing an ongoing study of the thoracotomy HVAD procedure in Canada and the U.S., where it does not currently have approval.

“The HVAD System is the only full-support, centrifugal LVAD approved in Europe for thoracotomy implantation, providing clinicians with greater freedom to choose the best surgical technique for each patient. CE Mark for the thoracotomy procedure is a testament to the HVAD system’s flexibility and versatility, and may enable more patients to receive the life-sustaining benefit of the device for the treatment of advanced heart failure,” VP and Medtronic HF biz GM Dr. David Steinhaus said in a press release.

HeartWare is currently engaged in 2 ongoing recalls of its HVAD devices, which it originally announced in September. Earlier this month, the FDA released updated information on the Class I recalls, which affect a total of 4,669 units.

The 1st recall is over issues with loose power connectors, which may cause the rear portion of the pump’s driveline connector to become separated from the front portion. A loose connector could allow moisture to entire the controller and cause corrosion, which could cause electrical issues, reduced speaker volume and connection failures.

The 2nd recall is related to design flaws in the driveline connector of the device which connects the HVAD’s pump to the external controller and power source. The flaw could cause contamination of the driveline which can result in fluid and material entering the pump and causing electrical issues or pump stops.

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Back to court: Nevro files new patent infringement suit against Boston Scientific

Nevro Corp. (NYSE:NVRO) said today it filed a patent infringement suit against Boston Scientific (NYSE:BSX), asserting that the company infringed on patents related to its Senza and HF10 spinal cord stimulation systems.

The suit, filed in the United States District Court for the Northern District of California, is seeking preliminary and permanent injunctive relief against further infringement, as well as damages and attorneys fees.

One of the patents in question, no. 8,359,102 was the target of 2 petitions for inter partes review as filed by Boston Scientific last November, and part of a spat which Nevro beat late last year.

The Patent Trial and Appeals Board of the U.S. Patent and Trademark Office declined the reviews, Nevro claims, saying that “Boston Scientific failed to establish a reasonable likelihood of showing that even one of the challenged claims of the ‘102 patent was invalid.”

“Nevro was founded in 2006 to develop meaningful advances in the treatment of chronic pain to improve patients’ lives. Intellectual property is the basis for innovation in health sciences given the long development timelines, investment, and risk required to bring meaningful advances to market.  We are committed to ensuring continued innovation in health sciences by protecting our intellectual property,” Nevro prez & CEO Rami Elghandour said in a press release.

The new suit follows a Nevro victory in a previous spat between the 2 last December, where Nevro beat a pair of challenges to 1 of its patents by Boston Scientific after the U.S. Patent & Trademark office declined to institute inter partes reviews.

Nevro’s Senza device, which won pre-market approval from the FDA in May, is designed to deliver up to 10,000Hz to the spinal cord, allowing it to avoid the tingling sensation known as paresthesia that bothers some patients. The FDA allowed the company to label the device as superior to other spinal cord stimulators, including some made by Boston Scientific.

The patent, no. 8,359,102, covers “Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods.” Boston asked the Patent Office to review the patent a week after the FDA approved Senza; in a pair of Nov. 30 decisions, the PTO’s Patent Trial & Appeal Board found that Boston Scientific “has not demonstrated a reasonable likelihood of prevailing on its assertion.”

The decision was “an outright victory” for Redwood City, Calif.-based Nevro, according to Leerink Partners analyst Danielle Antalffy, who predicted the win in September, and “will likely make it increasingly difficult for BSX to come to market with a high frequency device without another workaround of NVRO’s patents.”

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Russian regulators expand list of implantable medical devices

By Stewart Eisenhart, Emergo Group

Russia’s medical device market regulator Roszdravnadzor has updated its list of products that qualify as implantable medical devices with 160 additions.

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.

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House to vote this week on 21st Century Cures Act

The U.S. House of Representatives is set to vote this week on the 21st Century Cures Act, which looks to speed up FDA approval of both new drugs and devices, as well as provide a boost in funding for medical research.

Leaders of the House and Senate said late on Friday they worked out a deal to pass the legislation, according to Stat News, though a final version of the bill is still in negotiation with Senate democrats.

The House will vote on the approximately $6.3 billion legislation, which would provide $500 million for the FDA and $1 billion to battling the opioid epidemic. The legislation also includes $4.8 billion to support 3 Obama administration research programs over 10 years – VP Biden’s cancer moonshot, the BRAIN Initiative and the Precision Medicine Initiative.

Much of the bill focuses on the FDA, including provisions to establish an expedited review for breakthrough devices, hastening reviews of drug-device combos and increasing patient participation in drug approvals.

The bill would also require the FDA to evaluate the use of “real world” evidence to support new uses and post-approval studies for previously approved drugs, as opposed to the gold standard of randomized clinical trials.

Medtech industry lobby group Advamed, which allegedly held regular, private meetings to help write the bill, posted a release supporting the passing of the Act.

“The package includes a number of important improvements to FDA’s medical device premarket program designed to increase the efficiency, predictability and transparency of the agency’s review process. The most significant of these builds on initiatives already underway within FDA to help create an expedited pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening or irreversibly debilitating diseases or conditions who have no or limited alternative treatment options,” AdvaMed wrote in a press release. “We urge Congress to take action of this important legislation as soon as possible for the benefit of patients everywhere.”

The bill, which was developed by the House Energy & Commercial Committee, passed the U.S. House of Representatives 344-77 last July.

The 21st Century Claims Act has been highly praised and criticized since it was brought forth. Last July, the New York Times published op-eds which slammed and praised the Cures Act, with sides claiming it would severely weaken, or transversely strengthen, the FDA.

Last December, the act drew criticism from consumer watchdogs and FDA experts after it was revealed that there was an unprecedented level of collaboration between the federal safety watchdog and the industry it regulates.

FDA documents released late last year showed collaboration between the FDA and the medical lobbying group, AdvaMed, even while Congress was holding public roundtables about the bill, according to BloombergBusiness.

The FDA’s Center for Devices & Radiological Health and AdvaMed “worked together on the proposed language for most of the device provisions in” the Cures Act, according to an FDA memo from an Aug. 7 meeting attended by Dr. Robert Califf, the cardiologist nominated by who President Barack Obama to be the FDA’s new commissioner. Executives from Johnson & Johnson(NYSE:JNJ) and St. Jude Medical (NYSE:STJ) also attended, BloombergBusiness reported.

“For the Senate version of 21st Century Cures, CDRH is currently working with AdvaMed to refine their regulatory strategy in a way that is agreeable to both parties,” according to the August meeting memo.

AdvaMed spokeswoman Wanda Moebius told the news service that the creation of the 21st Century Cures bill was a “very open and inclusive process collecting input across the health care community via written statements, town hall meetings, roundtables and hearings.”

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Bovie Medical closes $6m offering

Bovie Medical (NYSE:BVX) today closed a $6 million funding round, floating 1.63 million shares of stock at $4 per share.

The round also included a secondary offering of 1.63 million shares made by certain stockholders of the company, Clearwater, Fla.-based Bovie Medical said in an SEC filing.

Net proceeds, after deducting discounts, commissions and expenses from the primary offering are expected to be $6 million, while all proceeds raised by the secondary offering will go to the selling stockholders.

The raised funds are on target with what the company was expecting when it priced the round earlier this month, expecting to bring in $12 million total to support expanding sales and marketing and R&D.

The offering includes a 30-day underwriters option to purchase an additional 450,000 shares of common stock, according to a press release.

Funds from the round will support the expansion of sales and marketing and research and development, as well as to conduct clinical trials and for general working capital and corporate purposes, the company said.

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Researchers develop bioresorbable capsule for treating hemophilia

Researchers from the Cockrell School of Engineering at the University of Texas at Austin have developed a biodegradable capsule to deliver a protein therapy for hemophilia. The research, published in the International Journal of Pharmaceutics, could provide a cheaper, less painful alternative to injections or infusions.

The capsule contains micro and nanoparticles which carry a protein therapy to treat hemophilia B. The disease is caused by a missing or defective factor IX, a clotting protein, in the blood. Access to the protein therapy is limited due to its cost and the complications brought on by needle-based drug delivery.

Get the full story at our sister site, Drug Delivery Business News.

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S-Cape, Medtronic reveal new connected ORs in Spain

Medtronic (NYSE:MDT) and German medical digital integration group S-Cape revealed updated, fully connected operating rooms at a Spanish hospital today.

The Andalusia region public healthcare service invested $1.27 million (EU €1.2 million) in creating a new operating room at Seville’s University Hospital Virgen Del Rocío, designed specifically for general and digestive surgery, according to Fridley, Minn.-based Medtronic.

The company said it partnered with the hospital to help develop the new operating room, the company said. The upgrade brings the total number of operating rooms at the hospital to 5, with the latest being equipped with connected technologies.

Other operating rooms were updated with features including automated work flows, advanced visualization capabilities and procedure recording, the companies said. Monitors and connected multimedia rooms were also added to allow for remote viewing and streaming of procedures to students, according to Medtronic.

Earlier this month, Medtronic said it joined Masimo (NSDQ:MASI) CEO Joe Kiani’s Patient Safety Movement Foundation with a $5 million, 5-year commitment.

By joining the program, Medtronic will provide $5 million over 5 years and share anonymized data from its medical devices to help develop analytic programs to help improve patient safety, according to a Patient Safety Movement Foundation release.

In addition, Medtronic CEO Omar Ishrak is slated to join the Patient Safety Movement Foundation’s board of directors.

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