May 25, 2017

By Jonathan Saltzman – GLOBE STAFF  MAY 24, 2017

A prominent Boston neurosurgeon was illegally forced out of his previous job at a New York hospital for strongly objecting to a policy that allowed another surgeon to perform complex spine surgeries on two patients simultaneously, a judge ruled.

Double-booking, as the practice is sometimes called, triggered a fierce dispute among doctors at Massachusetts General Hospital in recent years, leading to the 2015 dismissal of an orthopedic surgeon who opposed it. But Dr. James Holsapple may be the first doctor to win a lawsuit alleging he faced retaliation for challenging the practice.

New York Supreme Court Justice James P. Murphy ruled after a bench trial that University Hospital in Syracuse retaliated against Holsapple after he spoke out about the surgeon running two operating rooms at once.

“Dr. Holsapple vehemently objected and opposed the procedures for valid public health and safety reasons,” Murphy ruled in a 13-page decision received by the neurosurgeon Monday.

Holsapple, now chief of neurosurgery at Boston Medical Center, was awarded $88,277 in lost wages under the New York State whistle-blower statute. His lawyer estimated that the award could top $150,000 because Holsapple is entitled to interest on lost wages.

Holsapple, who resigned under pressure from University Hospital in 2009 and moved to Boston, said he felt vindicated.

“I did what I thought was right, and I’m grateful that the judge who heard the case saw it the same way,” said Holsapple, who heads the neurosurgery department at the Boston University School of Medicine.

The New York attorney general’s office, which defended University Hospital as part of the State University of New York, referred all questions to the hospital. Darryl Geddes, a hospital spokesman, said he could not comment because the attorney general’s office is considering an appeal.

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Megan Brooks, Medscape – May 18, 2017

The US Food and Drug Administration (FDA) has cleared the iovera device, from Myoscience, Inc, for the relief of pain and symptoms associated with knee osteoarthritis (OA) for up to 90 days. Myoscience is located in Fremont, California.

“The iovera technology is a nonopioid and nonsystemic treatment for blocking pain signals from peripheral nerves,” the company said in a news release announcing FDA 51(k) clearance of the device.

The device uses the body’s natural response to cold to treat peripheral nerves. It consists of a hand piece equipped with a nitrous oxide cartridge and three closely spaced 27-gauge closed-end needle tips. The nitrous oxide flows from the cartridge to the needle tips, creating a highly localized cold zone. The effect is transient and provides pain relief until the nerve regenerates and its sensory function is restored.

“The iovera technology has the potential to change the current paradigm of pain management for osteoarthritis. The patients that I have treated with this technology have experienced immediate and long-lasting pain relief and are grateful to have an option that is nonnarcotic and nonsystemic,” Vinod Dasa, MD, member of the Myoscience medical advisory board, said in the release.

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May 17, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)– May 15, 2017

Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS® Shoulder Application. Combining preoperative planning with computer-assisted surgery, the industry-leading technology allows for greater intraoperative visibility in both standard and challenging shoulder arthroplasty.

“The ExactechGPS Shoulder Application offers groundbreaking technology that is unique to the industry and should continue our selling momentum that delivered 21% growth in the first quarter,” said Darin Johnson, Vice President, Extremities Marketing. “Allowing surgeons to preoperatively plan the surgery and then execute it with a computer-assisted solution will help patients by ultimately improving outcomes. Importantly, it also reflects Exactech’s philosophy of keeping intraoperative decision making and control in the surgeon’s hands.”

An introduction to the new technology was the focal point at the recent 2017 Exactech Shoulder Masters Course, with live broadcasts of two surgeries performed by Pierre-Henri Flurin, MD, in Bordeaux, France.

“The live surgeries featuring the new ExactechGPS shoulder application for both anatomic and reverse total shoulder cases were incredible as it felt like we were in the operating room. It was exciting to witness the most advanced innovation in shoulder arthroplasty since reverse shoulders were first introduced,” said attendee Samuel Antuña, MD.

Setting a new standard in medical education, the Masters Course’s comprehensive scientific program featured 35 presentations by distinguished faculty who shared their experiences and philosophies with more than 150 surgeons from 17 countries around the world. Faculty member Joseph Zuckerman, MD, said, “This was one of the highest quality educational meetings I have participated in during my professional career. Between the scientific and technical presentations, debates, live surgeries and interactions between our surgeon peers, it was a truly unique and rewarding experience.”

The ExactechGPS Shoulder Application’s preoperative planning tool is designed to help surgeons understand their patient’s anatomy prior to surgery. Intraoperatively, ExactechGPS provides visibility into the glenoid vault in real time and allows for consistent, accurate glenoid placement.¹ A recent study showed that more accurate glenoid placement minimizes complications and theoretically increases implant survivability.² In addition, ExactechGPS provides a real-time view of retroversion and inclination, reaming and drilling depth, screw placement and the ability to adjust surgical plan intraoperatively, offering surgeons more flexibility.

The ExactechGPS Shoulder Application has been used successfully in the U.K., Spain, France and Australia. The initial launch in the U.S. is planned for this quarter. It is the latest addition to the Equinoxe® Shoulder System, which has been one of the fastest growing shoulder lines on the market since its introduction more than a decade ago. This year marks the 10^th anniversary of the first implantation of the Equinoxe reverse shoulder; Equinoxe products will be implanted in the 100,000^th patient before the end of this year.

1. Data on file at Exactech*
2. Walch G et al. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J. Shoulder and Elbow Surg. (2011) 20; 385-394.

* In vitro (bench) test results may not necessarily be indicative of clinical performance.

About ExactechGPS

ExactechGPS combines surgeon expertise with an advanced computer system to perform the patient’s surgery with a goal of improved accuracy and precision. Personalized for a patient’s unique bone structure and anatomy, ExactechGPS is designed to allow surgeons to decide where to remove bone and place the implant in the optimal position. Exactech first introduced ExactechGPS to surgeons in the United States for total knee arthroplasty, and has since broadened its reach by providing medical education and supporting surgeries in more than 11 countries. The technology has steadily gained market acceptance and worldwide reach.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.