eNews January 5, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

Kinder, gentler ACL repair

The U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant by Miach Orthopaedics Inc., is a resorbable implant—meaning it is absorbed by the body—made from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient’s ACL. The patient’s own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the body’s healing process. Within about eight weeks of the procedure, it is absorbed and replaced by the body’s own tissue. The De Novo premarket review pathway is a regulatory pathway for low- to moderate-risk devices of a new type.

Tenet keeps chasing ambulatory surgery

Tenet Health got its start as a major hospital operator in the U.S. and can trace its hospital business roots as far back as 1969. But it may be time to think of the Dallas-based company as an ambulatory surgery center (ASC) operator, first, and a hospital chain, second, according to MedTech Dive. Following its recent acquisition of 45 ambulatory surgery centers from SurgCenter Development, Tenet will now operate 310 ASCs in 33 states. Its ASC footprint will be nearly five times larger by the number of facilities than its hospital portfolio, and its ambulatory earnings will account for nearly half of the company’s overall earnings in 2021, executives recently said. That’s a significant leap from about six years ago, when ambulatory represented just 4% of the company’s earnings.

Implant for above-the-knee amputations

The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System by a Swedish firm, Integrum AB. It is the first implant system marketed in the U.S. for adults who have transfemoral—or above-the-knee—amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. A conventional leg prosthesis uses a specially fitted, cup-like shell (socket) that fits over the remaining portion of the patient’s leg (the residual limb remaining after amputation) to secure the device to the leg. Some patients may not have a long enough residual limb to properly fit a socket prosthesis or may have other conditions, such as scarring, pain, recurrent skin infections or fluctuations in the shape of the residual limb that prevent them from being able to use a prosthesis with a socket. The OPRA Implant System is surgically anchored and integrated into the patient’s remaining thigh bone to allow connection to an external prosthetic limb. The OPRA system has been on the market under a humanitarian device exemption since 2015. The recent approval expands the patient population eligible for this device. 

2020: The year of the catheter

As the COVID-19 pandemic took over the world in 2020, medical device companies continued to showcase new catheter innovations, reports Medical Tubing + Extrusion. The year 2020 saw FDA clearances, approvals and product launches for a variety of catheter-based technologies, including renal denervation systems, heart failure treatment catheters, mechanical thrombectomy systems and more. The list includes giants like Boston Scientific and Philips, as well as smaller companies like ReCor Medical and Revamp Medical. In December ReCor Medical of Palo Alto, California, won FDA breakthrough device designation for its Paradise ultrasound renal denervation system, an investigational device that is designed to treat hypertensive patients who may not be sufficiently responsive to or are intolerant of anti-hypertensive medical therapy. The technology is catheter-based and uses ultrasound energy to interrupt the renal sympathetic nervous system for better blood pressure control.