Zimmer Biomet Holdings, Inc. ZBH recently received the FDA 510(k) consent for its flagship Persona Revision Knee System for revision knee replacement procedures. The commercial launch of this system in the United States is expected in the next few weeks.
The revision system is expected to provide anatomic components, which are personalized to match that of a patient. With this launch, the company expects to broaden its knee replacement product offerings.
Significance of the Approval
The availability of this product will provide surgeons with a portfolio full of a variety of knee arthroplasty care and the ability to truly modify an implant solution based on patients’ exclusive requirements.
About Persona Revision Knee System
The Persona Revision Knee System will be available with a modern, intuitive instrumentation platform, which will enable surgeons to take a more tailored surgical approach while addressing simple or complex revision procedures by offering flexibility.
This system makes use of the company’s proprietary technologies like Trabecular Metal Technology and Vivacit-E Highly Crosslinked Polyethylene (“HXPE”), which have been designed to improve optimal fit and function.
The Trabecular Metal Technology is a unique highly porous biomaterial made from elemental tantalum, having structural, functional and physiological properties similar to that of a bone. The company claims this to be one of the most clinically recognized technologies, based on the fact that it is the only tantalum-based porous material currently available in the market.
Per a report by Global Market Insights, the total knee replacement market was valued over $8 billion in 2017 and is expected to witness growth of around 3.7% CAGR between 2018 and 2024. The market is set to grow as chronic bone disorders such as osteoporosis and rheumatoid arthritis are increasing in the elderly population.
Given the current market growth prospects, the latest clearance has come at just the right time.
Some Recent Developments
The company has been witnessing a slew of developments of late.
On Aug 16, 2019, it received the FDA approval for The Tether, which is to be used in the treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. This was the first approval order for a humanitarian use device in spinal pediatrics in the last 15 years.
In March this year, the company received the FDA 510(k) clearance for the ROSA ONE Spine System for robotically assisted minimally invasive and complex spine surgeries. This is likely to boost the company’s existing ROSA ONE Brain and ROSA Knee group.
Zimmer Biomet received the FDA clearance for the robotic surgical navigation and positioning system, ROSA ONE Brain, in February this year. The advanced neurosurgical device was planned to be used in neurosurgical surgeries and other procedures.
Further, the company received the FDA 510(k) clearance for ROSA Knee System in January 2019. It comprises 3D pre-operative planning tools and real-time intraoperative data on soft-tissue and bone anatomy, which have been designed to improve bone cut precision and an array of motion gap analysis to possibly improve flexion and restoration of natural joint movement.
Share Price Performance
The company has gained 11.2% in the past year compared with the industry’s growth of 0.3% and the S&P 500 index’s rally of 1.9%.
Zacks Rank & Stocks to Consider
Currently, Zimmer Biomet carries a Zacks Rank #3 (Hold). A few better-ranked stocks from the broader medical space are Baxter International Inc. BAX, GW Pharmaceuticals PLC and Neurotrope, Inc. NTRP.
Baxterwith a Zacks Rank #2 (Buy), has a projected long-term earnings growth rate of 12.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GW Pharmaceuticals estimates third-quarter earnings growth rate to be 72.8%. It currently sports a Zacks Rank #1.
Neurotrope, with a Zacks Rank #1, has a projected third-quarter earnings growth rate of 27.7%.
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