The evolution of transcatheter aortic valve replacement (TAVR) in the last decade has proven to be successful at improving quality of life for the majority of patients. Nevertheless, the most feared, frequently observed TAVR-related embolic complication is stroke or transient ischemic attack (TIA).
The Emblok Embolic Protective System from Innovative Cardiovascular Solutions LLC (ICS) is the first embolic protection device to provide full circumferential aortic collection during an entire TAVR procedure.
EMBLOK EMBOLIC PROTECTIVE SYSTEM
The device, which uses an embolic filter to safeguard the cerebral, abdominal and peripheral vasculature, is expected to receive CE mark by this fall, and US FDA approval by 2020.
In contrast, the FDA-cleared filter system from closest competitor Boston Scientific Corp., Sentinel cerebral embolic protection system, protects only two of the three cerebral arteries, brachiocephalic and left common carotid artery, leaving the vertebral artery orphaned during the procedure. Consequently, the distal vascularization is not protected from embolic material. (Also see "Market Intel: Martin Leon's TAVR Technology Tour Of The Future" - Medtech Insight, 5 Oct, 2018.)
The Sentinel system is inserted through the radial artery, which requires a 6 Fr puncture site in the wrist to successfully place one filter each in the brachiocephalic artery and the common carotid artery.
“In contrast, the Emblok device is deployed just proximal to the brachiocephalic artery, which is the first of the three arch vessels supplying blood to the brain,” R. Kevin Plemmons, CEO of ICS toldMedtech Insight. “By effectively protecting the brachiocephalic artery, we can protect the entire body – not only the critical three cerebral arteries -- but downstream as well to the abdominal and peripheral vasculature.”
“By effectively protecting the brachiocephalic artery, we can protect the entire body – not only the critical three cerebral arteries -- but downstream as well to the abdominal and peripheral vasculature," said R. Kevin Plemmons, CEO of Innovative Cardiovascular Solutions.
Keystone Heart Ltd. (TriGuard) is ICS’s second closest rival. The company deploys a nitinol mesh that deploys in the arch of the aorta. The mesh is designed to cover the aortic arch while deflecting embolic debris downstream, not collect and remove, Plemmons explained.
”Once embolic material is released from the heart and travels up the ascending aorta, embolic material hits a deflector and bounces off, thus directing the debris downstream toward the abdominal and the peripheral vasculature,” Plemmons said.
Innovative Cardiovascular Solutions LLC
1111 Short Road
Kalamazoo, MI 49008
Phone: (269) 599-6572
Contact:R. Kevin Plemmons, CEO
Business: Embolic protection system for TAVR and other structural heart procedures is the first embolic protection system to fully protect the cerebral, abdominal and peripheral vasculature from liberated embolic debris, which is an unfortunate byproduct of such procedures.
Founders:William Merhi (Spectrum Health, Grand Rapids, MI); R. Kevin Plemmons
Number of Employees:5
Financing to Date:$18m
Board of Managers:William Merhi; Shayne Plemmons, CFO; R. Kevin Plemmons
Scientific Advisory Board:Federico De Marco (Policlinico San Donato, Milan, Italy); Azeem Latib (Montefiore Medical Center, Bronx, NY); Jeffery Popma (Beth Israel Deaconess Medical Center, Boston)
Recent studies suggest that the kidneys could be vulnerable during TAVR as well.
ICS is targeting the TAVR market with its Emblok device.
For 2019, TAVR is projected to treat about 150,000 patients globally with severe aortic stenosis (AS), translating into a $5bn market.
And by 2025, there will be an estimated 300,000 patients annually who could benefit from Emblok, representing a $12bn TAVR market. (Also see "ACC Results Recap Part I: Low-Risk TAVR Trials Bring Good News For Edwards And Medtronic; Apple Watch Detects AFib In Apple Heart Study" - Medtech Insight, 19 Mar, 2019.)
The inventor of the Emblok Embolic Protection System is William Merhi, an interventional cardiologist and director of the Structural Heart & Valve Center at the Meijer Heart Center in Grand Rapids, MI.
The greatest hurdle in developing the Emblok device was to create a filter that could expand to a 40 mm diameter in a delivery system, which could house a 4 Fr radiopaque pigtail catheter that would be 11 Fr compatible.
The filter is composed of teflon (polytetrafluoroethylene or PTFE) and is drilled with thousands of microholes, enabling blood flow. It can capture debris greater than 110 microns.
Prior to joining ICS in 2013, Plemmons was the co-founder and CEO of
Ostial Solutions LLC, which developed a device for precise stent implantation in aorto-ostial lesions.
The privately held company was sold in 2012 to Merit Medical Systems Inc. for an undisclosed amount.
ICS has two issued and two pending patents, and will not be sharing royalties and/or revenues with another entity. The single-use, disposable Emblok system consists of two user components: a built-in 4 Fr radiopaque pigtail catheter that runs through the center of the handle of the device, and the delivery system itself which stores the filter.
“We are able to deliver two devices – the pigtail and the filter – in one single 11 Fr femoral puncture site,” Plemmons said.
How It Works
To begin a TAVR procedure, an interventional cardiologist who specializes in structural heart procedures inserts the Emblok device into the femoral artery. The filter is then positioned proximal to the brachiocephalic artery, while the pigtail catheter is advanced to the non-coronary cusp to perform aortography.
Lastly, the filter is unsheathed and expanded to the desired diameter of the aorta. The TAVR delivery system is then advanced over the top of the filter in route to valve deployment.
“The most important thing is to protect the brain continuously during the entire procedure, so the filter needs to be deployed as soon as possible and certainly before any other devices are introduced,” Plemmons said.
The in-patient procedure lasts between 45 minutes to one hour and is performed under minimal sedation. Patients typically remain in the hospital for one to three days. Plemmons said the learning curve for the Emblok device is usually one or two cases, because it is based on standard interventional technique.
An ongoing clinical study of the device began in March 2017 and has enrolled 22 patients to date, with a total of 50 patients planned. Outcomes from the first 20 patients have been promising: all Emblok filters contained embolic material and there have been no reported stroke, major adverse cardiovascular and cerebrovascular events (MACCE) or other complications.
The study is expected to be completed in the fall, with results shared publicly by year-end. The trial is designed to evaluate the safety and efficacy of the Emblok system, as well as the incidence of new brain lesions as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI).
“We can measure the volume of new lesions to judge if our filter has done an adequate job protecting the brain,” Plemmons explained. “We expect to show a significant reduction in lesion volume and in embolic hits or particles that enter the brain, which can lead to stroke and neurocognitive decline.”
Emblok is scheduled to begin selling in Europe early next year through a distribution network, with reimbursement yet to be determined. A likely direct US sales force is planned for near the end of 2020, along with expected reimbursement.
ICS has raised $18m to date, solely through angel investors: a Series A of $5m closed in May 2013, a Series B of $5m concluded in June 2018, and a Series C of $8m closed this past December. The company does not anticipate needing any additional funds.
One angel investor is interventional cardiologist Punett Khanna, director of the cath lab and the valve program at Eisenhower Hospital in Rancho Mirage, CA. Khanna is impressed with Emblok’s debris protection filter that is incorporated into the pigtail catheter for ease of use.
“You are not adding a whole lot of steps to the TAVR procedure,” Khanna told Medtech Insight. “However, it does require a slightly larger sheath: an 11 Fr instead of a 6 Fr. But for operators who routinely insert 14 or 16 Fr sheaths, this difference is not a stretch.”
Emblok also provides global protection.
“It captures anything that might break loose during the entire procedure, which no other device out there currently does,” Khanna said. “Emblok is a better mousetrap.”
“It captures anything that might break loose during the entire procedure, which no other device out there currently does,” said interventional cardiologist Punett Khanna. “Emblok is a better mousetrap.”
Khanna anticipates a rapid adoption of Emblok, because it is highly intuitive and easy to use, in contrast to many similar devices in development.
The only approved device, Boston Scientific' Sentinel, is inserted from the wrist, thus eliminating 20% to 30% of patients due to inability to deliver the device, Khanna said. It also adds another 15 to 30 minutes for placement.
“I think Emblok is a huge step forward,” Khanna said. “Every interventional cardiologist will be able to use the device without necessarily having to expand their skill set or learn to do something differently.”
ICS has had several conversations with major strategics that either manufacture their own percutaneous valve or want to enter this rapidly growing market. The company is prepared to remain independent, but is open to acquisition.
In addition, Emblok’s platform is applicable to a wide variety of other structural heart procedures where collecting embolic debris is important, such as atrial fibrillation (AF) ablation, percutaneous mitral valve repair or replacement and left atrial appendage closure.