Fully dissolving heart stent receives positive review

Departments - FDA, Mergers, & Funding

Ethicon acquires NeuWave; Olympus helping target therapy in lung cancer; Depuy Synthes acquires Biomedical Enterprises; Implementing a medical device evaluation system

July 6, 2016

An independent panel of experts convened by the U.S. FDA voted 9 to 0, with one abstention, that the benefits of a fully dissolving heart stent outweigh the risks. Abbott’s Absorb fully bioresorbable, drug-eluting coronary stent, is a first-of-its-kind device for the treatment of coronary artery disease. Instead of metal, the stent uses naturally dissolving material which dissolves completely after two-to-three years, during which it has kept the clogged artery open and promoted healing.

The FDA panel voted 9 to 1 in favor of the device’s safety and 10 to 0 in favor of its efficacy. The advisory committee reviewed data from multiple studies of the Absorb dissolving stent and found that the device has demonstrated comparable outcomes to the leading permanent metallic stent. Abbott submitted its pre-market approval application in mid-2015, and the FDA’s final decision is expected later this year. www.abbott.com

Ethicon acquires NeuWave

Ethicon officials have announced the completion of its acquisition of NeuWave Medical Inc., a privately held medical device company that manufactures and markets minimally invasive soft-tissue microwave ablation systems.

“Currently, there are limited treatment options for soft-tissue, non-resectable lesions,” says Michael del Prado, company group chairman of Ethicon. “Together with NeuWave Medical, Ethicon can bring minimally invasive treatment options to make a difference for patients around the world.”

NeuWave Medical’s products are used by physicians in more than half of the top cancer centers in the United States, and the Certus 140 ablation system’s high-powered computer and touchscreen interface enables the activation of single or simultaneous multiple-probe procedures for patients with soft-tissue lesions. This allows physicians to tailor ablations for lesions of varying shapes and sizes.

“This acquisition provides NeuWave Medical the ability to accelerate our innovation pipeline and expand the global footprint of our technologies, while allowing Ethicon to reach new patients by expanding the availability of a novel intervention that goes beyond surgical options in use today,” says Dan Sullivan, CEO and president, NeuWave Medical. www.ethicon.com

Olympus helping target therapy in lung cancer

Olympus’ 510(k)-cleared ViziShot Flex 19G EBUS-TBNA needle is for use in endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) – a minimally invasive alternative to surgical procedures and considered the gold standard for lung cancer staging.

EBUS uses a bronschoscope equipped with ultrasound capabilities to see beyond the walls of the airways and detect diseased tissue, lymph nodes, or lesions. Suspect lymph nodes can then be sampled using a special aspiration needle. This ViziShot Flex 19G provides a larger sample size, which can provide more material for molecular biomarker testing, potentially leading to more targeted therapy for the patient. The ViziShot Flex 19G offers a 72% increase in inner surface area compared to the Olympus ViziShot 21G needle and 144% increase compared to the ViziShot 22G needle.

Benefits include:

  • Larger sample size: Substantial tissue collection even in highly challenging areas, enabling genetic biomarker testing to determine the correct therapy
  • Better access during EBUS-TBNA: Flexibility allows the scope to flex up to 84° for improved access to difficult-to-reach areas, sample acquisition; needle echogenicity improves precision and control
  • Safety: Includes a double-locking mechanism to help avoid accidental needle protrusion www.medical.olympusamerica.com

Depuy Synthes acquires Biomedical Enterprises

DePuy Orthopaedics Inc., part of the DePuy Synthes companies of Johnson & Johnson, has acquired privately-held BioMedical Enterprises Inc. (BME), a manufacturer of Nitinol orthopedic implants for small bone fixation. The implants are used to treat bunions, hammertoes, and other foot, ankle, hand, and wrist deformities. The BME acquisition reinforces Johnson & Johnson Medical Devices’ focus on strengthening DePuy Synthes’ portfolio for elective extremity procedures.

“The BME portfolio will be integrated into our trauma platform, where we will be able to expand the availability of these solutions, increase the pace of innovation in this area, and reach more patients around the world,” says Ciro Römer, company group chairman, DePuy Synthes. www.depuysynthes.com

Implementing a medical device evaluation system

A report from the planning board for a national medical device evaluation system (NMDES) describes how the nation can implement a coordinated network of partners to improve evidence on the safety and effectiveness of medical devices. The system will work to improve patient outcomes by being smarter and more efficient when generating and evaluating real-world electronic health data on medical devices.

In a previous report, the planning board described how major gaps in the nation’s ability to reliably track medical device safety and effectiveness significantly affect public health. The inability to collect robust and timely evidence on devices increases the costs and inefficiency of our healthcare system. The new report describes how the United States can establish a national system by coordinating and building on the work of a nationwide network of partners, including the FDA and other public agencies, patient communities, provider systems, medical device manufacturers, academic institutions, and healthcare payers.

The NMDES should give device manufacturers a faster, more predictable path to approval and health care coverage decisions. Once products are on the market, the NMDES would provide more cost-effective approaches to developing real-world evidence, which would give clinicians and insurers greater confidence in the products they use. The system would develop resources that improve medical device safety updates, recall management and effectiveness data, and a recommended public-private coordinating center would be responsible for demonstration projects to show the value of NMDES in its early stages. www.healthpolicy.duke.edu