Showing all posts written by Mason Marks, M.D.

Mason Marks, M.D.
FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven cervical implant and its first to be approved for use in both one-level and two-level procedures. The system was approved to treat single-level cervical disc disease in July of 2014, and approval for use at two adjacent levels was granted earlier this month. As described in Medtronic’s press release, the ball-and-trough design of the Prestige LP allows a variety of movements including bending, rotation, and translation.

According to Medtronic, the Prestige LP Cervical System serves as a complete replacement for one or two intervertebral discs. The human spinal column is composed of twenty four vertebral bones stacked on top of each other. The uppermost seven bones are referred to as the cervical vertebrae, and they are labeled C1 – C7. Flexible intervertebral discs (Fig. 2 below) act as shock absorbers between adjacent vertebrae. Each disc is composed of an inner jelly-like material called the nucleus pulposus and a tough outer wrapping called the annulous fibrosus. In addition to cushioning shock, the discs allow bending, twisting, and flexion of the spine.

According to the Arthritis Foundation, wear and tear on intervertebral discs is part of normal aging. As we grow older, the discs can dry out and lose their shock absorbing capacity. Stress from daily activities can cause tears in the annulous fibrosus resulting in herniation of the inner jelly-like core. Furthermore, because intervertebral discs have little blood supply, their ability for self-repair is limited. As a result, once a disc is injured, it may continue to deteriorate. Studies using Magnetic Resonance Imaging (MRI) show that nearly everyone over age 60 has at least some disc degeneration. However, not all people affected by disc degeneration will experience discomfort. According to the American Academy of Orthopaedic Surgeons, pain and disability due to cervical disc degeneration are often treated with physical therapy, anti-inflammatory medications, and steroid injections. When these options fail to alleviate symptoms, surgical options may be considered.

According to the UCLA Spine Center, the traditional surgical approach to treating cervical disc disease involves removing the affected disc (called discectomy) and using metal hardware to fuse the vertebrae above and below it. The preferred procedure is called Anterior Discectomy and Cervical Fusion (ADCF). During ADCF, the diseased disc is removed and replaced with bone graft or a plastic spacer. Adjacent vertebrae are then fused using a metal plate and screws. Because normal cervical discs are flexible and permit movement of adjacent vertebrae, cervical discectomy and fusion can restrict neck motion. However, compared to this traditional approach, replacing a diseased disc with an implant can allow for greater neck motion after surgery and reduce stress on remaining vertebral bodies (Fig. 3 below).

The Medtronic Prestige LP Cervical Disc joins others that are FDA approved for use at two vertebral levels. In August, 2013 the Mobi-C Cervical Disc (Fig. 

Surgical, Medical, and Assistive Robotics

Surgical, Medical, and Assistive Robotics

Robotic technology has been used in medicine for over 30 years. In 1985, a robot called the Puma 560 (shown at right) was used to perform a needle biopsy of human brain tissue. By the turn of the last century, it was widely recognized that robots could provide increased precision, stability, and dexterity in the operating room. The technology has since led to many advances in minimally invasive surgery, which allows procedures to be performed through one or more small incisions or ports. With smaller incisions come benefits such as decreased pain, blood loss, and recovery time.

According to Dr. Eric J. Moore, a head and neck surgeon at the Mayo Clinic, the most widely used robotic surgical device is the da Vinci system (shown at left) manufactured by Intuitive Surgical (NASDAQ: ISRG) based in Sunnyvale, CA. The da Vinci was the first robotic system to be FDA approved for general laparoscopic procedures. It was introduced in 1999 and is currently used to treat a variety of conditions including prostate cancer, inflammatory bowel disease, and mitral valve prolapse. This January the FDA approved an integrated motion table, developed in collaboration with Trumpf Medical, for use with the da Vinci system. It allows surgeons to reposition the patient during a procedure without having to disconnect the surgical robotic arms. Earlier this month, the FDA approved Intuitive Surgical’s da Vinci Xi single-site instruments and accessories, which permit surgeons to perform single and multi-port surgeries using one robotic system. Intuitive Surgical holds over 100 patents on surgical robotic systems, software, parts, and accessories.

The global market for surgical robotic systems is expected to grow significantly in the next 5 years. It was estimated to be worth $3.3 billion in 2014 and is estimated to reach $6.4 billion by 2020. In recent years, several competitors have emerged to challenge Intuitive Surgical, which according to Reuters, holds a dominant position in the surgical robotics market.  TransEnterix (NYSE: TRXC) is a medical device company in the Research Triangle area of North Carolina. TransEnterix is currently seeking 510(k) clearance from the FDA for its SurgiBot single-port robotic surgery platform. The company also markets a multi-port system called the ALF-X.

Last year Google’s Verily and Ethicon, a medical device company owned by Johnson & Johnson, partnered to form Verb Surgical of Mountain View, California. Verb has reportedly hired over 100 people including Scott Huennekens a former CEO of the Volcano Corporation. Though no specific products have been announced by Verb Surgical, the company’s website promises to create the future of surgery, which will involve robotics, big data, advanced imaging & instrumentation, and machine learning. Heunnekens says the first Verb surgical platform will incorporate these “pillars of digital surgery” and will be in operating rooms within 5 years.

Since the origin of medical robotics over 30 years ago, robots have migrated out of the operating room and into the recovery room. Assistive robotic systems help people with disabilities accomplish activities of daily living such as eating and walking.

FTC Approves Tornier and Wright Medical Merger

FTC Approves Tornier and Wright Medical Merger

The U.S. Federal Trade Commission (FTC) recently issued a final order that conditionally approves the merger between Amsterdam, Netherlands-based Tornier N.V. and Memphis, Tennessee-based Wright Medical Group, Inc.  Reuters reports that the all-stock transaction is valued at about $3.3 billion.  Plans for the merger were first announced in October 2014, and approved by the shareholders of both companies in June 2015, subject to receipt of clearance by the FTC.  Progress on the transaction was suspended when the FTC expressed concerns that the merger would reduce competition for total ankle replacements and total silicone rubber (silastic) toe replacements in the U.S. market.

The FTC’s Bureau of Competition enforces U.S. antitrust laws and works with the Bureau of Economics to investigate alleged anticompetitive business practices.  On occasion, the Bureau urges the Commission to take law enforcement action. In this case, the FTC’s concerns were the final obstacle to the proposed merger. The recent final order, which follows a mandatory public comment period, settles the FTC’s allegations of anticompetitive behavior.

The order calls for Tornier to sell a portion of its U.S. assets and IP rights to Integra Lifesciences Corporation (NASDAQ: IART), a competitor in the U.S. orthopedics space, which is based in Plainsboro, New Jersey.  The newly combined company will be required to provide Integra with ankle and toe replacement products for up to three years. Through this arrangement, the FTC seeks to foster competition in the affected market.

In addition to its upper and lower extremity portfolio, the merged companies will  maintain a presence in the growing biologics market.  Wright Medical recently obtained FDA approval on the Augment bone graft material (left), which is as an alternative to autograft in a variety of arthrodesis procedures.  Tornier has developed a line of biologics that includes its BioFiber line of absorbable scaffolds and its Conexa reconstructive tissue matrix, both of which are used for soft tissue repair.

The U.S. market for cell-based therapies for musculoskeletal injuries (orthobiologics) is valued at over $1.5 billion and is expected to grow significantly in 2016.  Other market participants in the orthobiologics space include Dublin, Ireland-based Medtronic (NYSE: MDT), San Diego, California-based NuVasive (NASDAQ: NUVA), Kalamazoo, Michigan-based Stryker (NYSE: SYK), and Johnson and Johnson’s West Chester, Pennsylvania-based DePuy Synthes (NYSE: JNJ).  Orthobiologics are part of the growing field of regenerative medicine, which includes bioprinting and stem-cell based therapies, and is projected to be worth $6.5 billion in the U.S. by 2019.  Bioprinting, itself, has received recent investment and growth.

Following the merger, the resulting company will be renamed Wright Medical Group, N.V. and will be incorporated and headquartered in the Netherlands.

3D Printing Partnership: 3D Medical Limited to Acquire Mach7 Technologies

3D Printing Partnership: 3D Medical Limited to Acquire Mach7 Technologies

3D Medical Limited (ASX: 3DM) recently announced that it has entered into a binding Heads of Agreement (HOA) to purchase 100% of shares issued in Mach7 Technologies.  According to the agreement, 3D Medical will issue 460 million shares to the owners of Mach7 in exchange for the company’s assets and intellectual property.  Up to 300 million performance shares will also be distributed if predetermined financial milestones are reached. The deal is valued at approximately $60 million USD.

3D Medical Limited is an Australian provider of 3D printing technology and services for use in clinical medicine.  The company’s “Touch 3D” service creates 3D printed models from CT or MRI scans.  The models may serve as visual aids for pre-surgical planning or be directly implanted during surgery. In June 2015, the company 3D printed a titanium jaw bone that was transplanted into a Melbourne man (Figure 1, right).  3D Medical subsequently received orders for 25 additional custom implants.

Mach7 Technologies is a US based provider of enterprise level medical imaging solutions.  Its Mach7 system promotes sharing of data between different departments or facilities and allows the consolidation of images from disparate software platforms.  The Mach7 platform is currently used in over 300 sites worldwide, including in leading academic medical centers in the United States.

The proposed merger will give 3D Medical additional exposure in US markets, and provide it with increased control over the 3D printing process from image acquisition through model and implant creation.  The company hopes to raise an additional $10.9 million Australian ($7.85 million US) in working capital to support the sales and marketing activity of Mach7, to decrease Mach7’s debt, and to further develop 3D Medical’s data offerings. On October 28th, 3D medical announced that it had raised $4 million through an oversubscribed private placement.

Following the deal, the merged companies will adopt the name Mach7 Technologies and operate out of a Melbourne headquarters.  The new company will offer four product lines, including Touch 3D printed models and implants, Mach7 image management solutions, the Visualize holographic projection platform (developed by EchoPixel), and the GestSure in-theater image manipulation system.

3D printing in medicine has gained momentum in recent years and some analysts predict the global market will reach over $965 million by 2019.  A variety of 3D printed structures such as teeth, skull, and pelvis have been implanted into human patients, and 3D printed heart models have been used to plan complex surgeries in patients with congenital anomalies (Figure 2, left).  Some companies, like San Diego based Organovo (NYSE: ONVO), use human cells in the 3D printing process, which is called bioprinting. Organovo is working with researchers at Yale University to develop bioprinted human organs for implantation, but for the time being, Organovo prints micro-livers for use in drug development.  Other companies in the medical 3D printing space include Belgium based Materialise (NASDAQ: MTLS), Michigan based EnvisionTEC, and Minnesota based Stratasys (NASDAQ: SSYS).

Materialise, EnvisionTEC, and Stratasys own a variety of patents related to 3D printing and implants.