Vascular Device Forum

Cook Medical Releases Branch Bifurcation Preservation Zenith device

Cook Medical continues their industry leading innovation in the endovascular space with the release of the new branch iliac bifurcation device. The device is available in Canada, EU and Australia.

 First Device Designed to Preserve Blood Flow to Iliac Arteries During Aneurysm Repair Receives Approval from Health Canada

Bloomington, Ind., November 3, 2009 – Canadian physicians can now treat patients suffering from life-threatening aneurysms in one of the body’s largest arteries with an endovascular graft delivered during a minimally invasive procedure without blocking a critical artery. The Zenith® Branch Endovascular Graft-Iliac Bifurcation from Cook Medical, approved today by Health Canada’s Medical Devices Bureau, is specifically designed to preserve flow to the internal iliac artery allowing for the endovascular treatment of both aortoiliac and iliac artery aneurysms that commonly occur in patients with abdominal aortic aneurysms (AAA). Aneurysms are bulges in the walls of the major arteries that left untreated can rupture causing death.

“Aortoiliac and iliac aneurysms are known to be particularly difficult to treat due to the tortuous anatomy,” said Dr. Cherrie Abraham of Jewish General Hospital in Montreal. “The control and stability of Cook’s branch graft offers precise deployment. The capability to preserve blood flow to the internal iliac artery is a crucial benefit, too, as it will help avoid complications that can arise from internal iliac embolization.”

The Cook branch graft is bifurcated, like the iliac artery itself, with openings to connect the common iliac, side branch (internal iliac) and external iliac segments. Built on Cook’s proven Zenith technology, which has been used for years in the endovascular treatment of aneurysms in other major vessels, the device preserves flow to the iliac artery, reducing the potential for complications such as colon ischemia, buttock and hip claudication or impairment, and impotence.

“The designs currently available on the market to treat iliac aneurysms endovascularly are simply not adequate for this surgery. With the introduction of the iliac branch graft, Cook is delivering an endovascular treatment to the Canadian market that previously was not an option,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention strategic business unit. “Cook is building on existing technologies designed to treat abdominal and thoracic aortic aneurysms, bringing the same level of innovation to the treatment of iliac aneurysms.”

 

The Zenith Branch Endovascular Graft-Iliac Bifurcation, which mimics the natural iliac artery anatomy, is made of thick woven polyester fabric sewn to self-expanding stainless steel and nitinol Cook-Z® stents with braided polyester and monofilament polypropylene suture. The graft is completely stented to provide stability and the force needed to open the lumen of the graft during deployment. Nitinol rings located at the proximal end of the graft and within the side branch help preserve lumen patency during access, and the stainless steel Cook-Z stents provide the necessary seal of the graft to the vessel wall. Gold markers positioned along the internal iliac side of the graft aid in precise positioning.

The Zenith Branch Endovascular Graft-Iliac Bifurcation is also available in the European Union and Australia. The device is not yet available for sale in the U.S., where it is currently regulated as an investigational device.

Cook Medical's TX2 ProForm Thoracic Endograft

I posted a previous forum on ProForm technology. Here is animation for the device deployment.

Download TX2-PROFORM-1TX2 Proform

Earlier post on the Zenith TX2 ProForm

 

Aptus Staple 2 device for EVAR-Another Hurdle Crossed

Endovascular Today announced the recent completion of the Aptus II study primary enrollment.This is the US study to demonstate safety and effectiveness of the Aptus stapling system from Aptus Endosystems, Inc (Sunnyvale, CA).  The device is an aortic endograft system that incorporates the companies proprietary stapling system.

This device will cross another hurdle that has been a long standing differentiating feature of open versus EVAR. Stable proximal fixation, especially in adverse proximal aortic neck anatomy.

The investigators enrolled 155 sequential patients across 25 US clinical trial sites as part of the study to assess the perioperative and long-term performance of the company's combination of stent graft and endovascular stapling system in the treatment of AAA. Patients enrolled in the study are subject to 1-, 6-, and 12-month follow-up reviews. The company will then submit data to the Food and Drug Administration (FDA) for review under the premarket approval process. The company intends to submit its final data module to the FDA early next year. Ronald Fairman, MD, and Manish Mehta, MD, are national coprincipal investigators for the STAPLE-2 study.

The company stated that STAPLE-1, the phase 1 study that enrolled 21 patients at five US institutions, produced positive clinical outcomes, which were presented in November 2008 at the VEITH Symposium in New York City. These study results showed no device-related endoleaks (type I, III, or IV) and no device migration as late as 2 years postprocedure for those patients who had reached that follow-up. Additionally, more than 90% of patients demonstrated a clinically significant reduction in their aneurysm size as early as 6 months postprocedure.

"The 1-year follow-up outcome data is particularly robust and impressive," commented Dr. Fairman. "The completion of the pivotal STAPLE-2 study brings the therapy to a new level. This truly novel concept of active proximal fixation using helical Ôscrews' combined with a modular endograft on a very small, flexible delivery system expands the option for endovascular therapy to a greater pool of patients."

"This endovascular stapling technology facilitates our ability to perform aneurysm repair in a manner that closely approximates the suturing technique that is the foundation of open surgical repair," added Dr. Mehta. "Having the ability to separately control the fixation of the endograft in a catheter-based technology is a new and clinically important capability relative to improved outcomes for patients."

 

Bart Muhs MD- EVAR technologies Today and Beyond

Dr Bart Muhs, Assistant Professor of Vascular Surgery and Co Director of Endovascular Surgery at Yale University School of Medicine, offered some exclusive insights to VascularDeviceForum.com. Dr Muhs was trained at New York University School of Medicine as a general surgeon and vascular fellow. He subsequently completed a PHD at Utrecht University. EVAR development is lead by an outstanding line up of US trained physicians(many of them surgeons I might proudly add) , including Tim Chuter MD who have broadened their exposure in EVAR space with post doc experiences in the fertile and less regulated landscape of the European medical environment. I do think that these doctors represent the new paradigm shift of physician specialization that is not limited by historic definitions of scope of practice as you may notice from Dr. Muhs academic title in the dept of radiology. Dr Muhs is one of the thought leaders for the field of EVAR assisting in creating a vision for sound research driven innovation that leads to clinically relevant aortic stent graft design.

Some of his current investigational work includes:

Abdominal aortic aneurysm – PYTHAGORAS Study. This study evaluates a new endovascular aortic stentgraft to treat abdominal aortic aneurysm in patients who would otherwise require an open surgery.

Thoracic aortic dissection – This study evaluates the use or thoracic stentgrafts to repair acute aortic dissections or tears that can occur in the descending thoracic aorta.

Abdominal aortic aneurysm – This trial uses magnetic resonance imaging to evaluate the effect of placing aortic stentgrafts for the treatment of abdominal aortic aneurysms. Information from this trial will allow for the design and development of improved stentgrafts with better patient outcomes.

Abdominal aortic aneurysm – This institutional study evaluates prognostic factors that can be used to improve patient outcomes following open and endovascular abdominal aortic aneurysm repair.

This is the first of a two part posting from this informative conversation. The prevailing theme in the conversation is that future advances in EVAR will likely be dictated by a greater appreciation for the physiologic differences that distinguish the aneurysmal disease, dissections and traumatic aortic injuries. As well as the age related physiologic differences in these respective pathologies. Aneurysm physiology and biochemistry will ultimately influence stent graft engineerying and design.

Dr Muhs is using EKG-gated phase contrast imaging of the aorta using MRI technology. Using 2mm windows, compliance is being measured in different areas of the aortic environment. Branch segments, angulated segments, posterior wall versus the anterior aneurysm wall. These parameters can be assessed in different aneuryms morphologies, age groups. The study is sponsored by the American Geriatric Society. This study hopes to provide insight into predicting aneurysm behavior based upon this PhaseContrast MRI. Currently the study has accumulated data on normal and healthy volunteers.

Next, we focused on three distinct areas of aortic pathology:

1)Trauma

2) Dissection

3) AAA

I received quite a few questions leading up to the Dr Muhs interview regarding the use of EVAR in repair of traumatic aortic tears. This group represents the potential for significantly improved outcomes with EVAR technology. Frequently, this blunt trauma pathology is associated with other injuries like pelvic injury and intra abdominal visceral injury. Significantly, increasing the trauma score. In this setting, minimally invasive prompt means to treat this aortic injury is potentially life saving, avoiding the need for open thoracic repair.

Dr Muhs work is particularly important in this context as it should reveal the clinically significant physiologic features that characterize the young person's aorta. Dr Muhs elaborated further: Anatomically, these patients have acutely angulated thoracic arches which are highly compliant. In his experience, one pearl involved in the preparation process is the aortic diameters measured by CT scanning in the hypovolemic, compliant aorta. He described an early patient or two that would undergo successful repair acutely only to have a type I leak on follow up. He recommends approximately 30% oversizing to address this concern.

Additionally, his prediction is that future research will demonstrate that many of these patients have completely healed their injury at 12 months or so. Raising the theoretical consideration that a bio absorbable device would obviate the need for a 20 or 30 year old person to have a current devicetype in place for the rest of their life. Ie a bio absorbable aortic stent graft. More to follow in the next post including our discussion about aortic dissections, the new frontier application for stent graft technology and our evolving understanding Please share your ideas about these innovative EVAR ideas

Cook Submits Application on Low Profile EVAR Device

Cook Medical announced submission of application for approval for a low profile endograft system for treatment of Abdominal Aortic Aneurysm (AAA). The low profile system is 16 Fr. in size compared to current diameters of 22-24 Fr for the main body. The large main body device profile may affect the ability to insert the device in under the circumstances of small access site diameter which is more common in women. Inability to insert the device at traditional access points in the groin may necessitate a more invasive pelvic incision or the inability to perform stent grafting and the need for traditional aneurysm surgery via an abdominal incision.

If approved, this technology improvement may reverse halt the slide in market share created by entry of the Talent Endograft from Medtronic. Although I have not seen the numbers, my perception is that there has been a migration to the Talent by some previous users of The Zenith device.

I would like to get some feedback regarding the number of proceduralist who would use percutaneous technique for the 16 Fr. It's a somewhat contradictory thought process that the subgroup that would most benefit from the small device size (elderly female, small vessels) is precisely the group that's most prone to complications from an attempt at percutaneous management of a 5 mm arteriotomy.

Editors note: The Veith Meeting is coming up. I hope to provide some real time updates regarding technology and industry events

Fenestrated Aortic Stent graft extends application in AAA

Science Daily reported the implantation of the Zenith Fenestrated aortic stent graft for the treatment of abdominal aortic aneurysm (AAA) from Cook Endovascular

"In a New York City metro-area first, a 93-year-old Bronx man underwent implantation of a new stent graft at NewYork-Presbyterian Hospital, the only center on the Eastern Seaboard with access to this investigational device. The new stent graft was implanted under an FDA-approved clinical trial protocol. The stent graft is designed to treat a complex form of abdominal aortic aneurysms in which the weakened, enlarged vessel wall is too close to the arteries leading to the kidneys."

"The unique device, known as a fenestrated endograft, is a tubular, fabric graft with supporting metal stents that features custom-positioned holes (fenestrations) that ensure proper blood flow through the aorta and to the kidneys and nearby organs."

The Advanced Medical Technology Association, whose members include Medtronic Inc. (nyse: MDT - news - people ) and Boston Scientific Corp. (nyse: BSX - news - people ), lobbied on legislation affecting the regulation of devices by the Food and Drug Administration and payments for technology by Medicare.

The medical device industry's chief advocacy group spent $924,074 lobbying the federal government in the second quarter of the year, according to a recent disclosure report.

Remembering Dr Debakey-Individualized Care Improved Outcomes

Unfortunately, The VDF was on hiatus at the time of Dr Debakey's death on Friday July 11, 2008. Dr Debakey was a surgical pioneer and professional role model for any physician, research or clinically oriented, who has ever aspired to better patient care. Dr. Michael Debakey, arguably one of the most influential doctors in the US. Dr. Debakey truly changed the face of medicine and made it possible for previously inoperable diseases to be treated. He had a profound impact on the medical world and his work has made it possible for patients today to have a chance at survival. His approach to solving medical and technical challenges to treatment is the paradigm for all of us. Read what close colleagues are saying about Dr Debakey's life.

It's ironic that Dr Debakey nearly died of an aortic dissection and aneurysm in 2006. The same pathology which he devoted much of his life to.  Angioplasty.org posted a fantastic interview in which Dr Debakey describes the story of what lead to development of the dacron vascular blood vessel substitute

A common thread in Dr Debakey's effort to treat vascular disease is his recognition that their are benefits of personalized and customized medical devices and how the “one-size-fits-all” mentality has to be challenged to successfully treat vascular disease. Dr. Debakey was a true advocate for top-of-the-line patient care and pioneered many of our eras frequently performed common procedures like aneurysm repair, bypass surgery and carotid endarterectomy.

As an example of this concept of unique, individualized patient solutions, Cook medical recently offered the latest improvement in their Zenith AAA platform.  The Z-Trak Introduction System and Zenith AAA
Flex Leg brings further flexibility to a strong EVAR platform

Talent Stent Graft from Medtronic AVE a challenge to Cook Zenith Endograft for EVAR

I have to admit that I was excited to hear about the recent release of the Talent Endograft from Medtronics AVE. Having participated as a fellow with Dr Bruce Brener and Michael L Marin in the US trial, I participated in over 70 implantations with the initial investigational device configurations. The early investigational Talent graft offered suprarenal fixation and easy, intuitive deployment.

But technology has evolved and the question is posed, "Is the Talent device too little, too late when one compares it to the the Zenith Graft from Cook.

I found a very nice medscape article describing development of the Talent Thoracic prosthesis including its initial development by World Medical until it subsequent .

Additionally the article describes other competitors in this thoracic space like the Zenith TX2 stent graft system and the Gore Tag Endo prosthesis

Also, Drs Milner and Wang wrote a very concise review in Vascular Disease on the currently available and pending Thoracic EndoGrafts.

Great article for a brief overview of the Thoracic endograft space

Is EVAR making a difference?...It seems so

Recent News

From Society of Vascular Surgery 2008

Researchers from Beth Israel Deaconess Medical Center in Boston report that in the U.S. population deaths from all abdominal aortic aneurysms (AAAs), as well as the total ruptured AAAs (rAAAs) is declining, while the number of elective repairs is increasing.

This study looked at a nationwide data base of hospital discharges. According to the investigators, during the last 17 years, the averae number of elective repairs performed annually has increased from 34,147 to 35,744 and the number of ruptures of AAA's decreased from 9,662 before the approval of EVAR to 7,017 after the approval of EVAR, and rupture repairs decreased rom 6,607 to 4617.

Source

Cook responds to Medtronic AVE Talent challenge with extension of EVAR Portfolio-Zenith TX2

The best thing about blogging is the immediate feedback that one receives by way of comments and emails. I get a very representative sampling of opinions about various devices and vascular intervention topics. Some are from opinionative clinicians and some are from industry insider's with a distinct bias. And I don't categorically believe that just because someone works for a company and sells a product, that they can't have a genuinely defensible bias for their product. I think that's up to the readers to decide for themselves.

I like to share these periodically because the exchange is very helpful and informative whether you're a practicing physician or a member of the vascular device industry. The following comment was in response to my opinion that, at least transiently, the Talent Endograft by Medtronic AVE will erode the market share of Cook's Zenith Endograft in the area of Endovascular Aneurysm Repair (EVAR) for infrarenal aneurysms with challenging anaotomy of large proximal aortic neck diameter

....regarding Medtronic’s Talent device as a threat to Cook’s Zenith device. Cook Medical’s TX2 TAA endograft received FDA approval on May 23^rd and as a result of Cook’s strong position in the industry and positive clinical data, the device has become a top choice for vascular surgeons.  This is demonstrated by Cook’s announcement of the first commercial placement of the Zenith TX2 in the United States a few weeks ago (release below). 

To demonstrate the benefits of the device, Cook sponsored the STARZ-TX2 clinical trial, a multi-national trial designed to study the safety and effectiveness of the Zenith TX2. The trial results indicated that the TEVAR procedure, using the Zenith TX2, is a safe and effective alternative to open surgical repair for the treatment of thoracic aortic aneurysms in patients with suitable anatomy.  Cook expects to grow to 30% US market share in the TAA market through 2009.

Cook's press release regarding the first implant:

Cook Medical Announces the First Commercial Placement of the Zenith TX2® TAA Endovascular Graft in the United States

Company’s Breakthrough Thoracic Aortic Aneurysm Endovascular Graft was Successfully Implanted In Cleveland, Ohio

Bloomington, Ind., June 24, 2008 – Cook Medical, the established world leader in developing advanced technologies to treat diseases of the aorta, announced the first commercial placement of its Zenith TX2® TAA Endovascular Graft in the United States. The groundbreaking procedure was performed on a 69-year-old male patient by Sean Lyden, M.D., a vascular surgeon and specialist in endovascular aneurysm repair (EVAR) practicing at a major medical institution in Cleveland, Ohio. Cook’s state-of-the-art aortic endograft is designed specifically to treat patients undergoing thoracic endovascular aortic repair (TEVAR) for descending thoracic aneurysms and ulcers.

“The first placement of the TX2 in the United States showcases the advanced medical technologies Cook brings to the marketplace and marks a step forward in treating a broad range of TAA patients, safely and effectively, worldwide,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention business unit. “Dr. Lyden and others have told us they’ve been eagerly awaiting this device because it deploys with such accurate control and is actively fixed to the aorta, unlike competing devices. We believe this is a dramatic improvement for patients in a section of the aorta that really challenges endovascular devices for durability and that frequently offers only limited surgical repair options.

“With the highly skilled support of vascular surgeons like Dr. Lyden, we are now able to serve U.S. patients affected by TAAs (thoracic aortic aneurysms) or ulcers with the most minimally invasive alternatives available. Cook’s TX2 can be used on an additional subset of patients who may have been ineligible for treatment through open surgery, giving those affected by the disease, the opportunity to be treated with TEVAR,” Nowell added.

“The commercial release of the TX2 really made a huge difference for this patient,” said Dr. Lyden. “Using a small groin incision we were able to accomplish repair of his aneurysm in about 45 minutes. The two-piece device allowed customization to the patient’s anatomy to sit perfectly at the level of the left subclavian artery proximally and distally to near the celiac artery and prior repair. The hydrophilic Flexor delivery system passed through his anatomy to the treatment area with remarkable ease. This device will clearly make a huge impact on treating thoracic aortic disease.”

TAAs occur when a section of the aorta weakens and bulges outward like a balloon.  The Cook Zenith TX2, a reinforced fabric tube that is sized to the length of the aorta is used to seal off the aneurysm, where it helps to relieve pressure on the aneurysm or ulcer and reduce the risk of rupture.  The Zenith TX2 device is deployed from a catheter inserted through a small incision in the patient’s femoral artery. This procedure is far less invasive than traditional open surgery where physicians open the patient’s chest, clamp off and remove the diseased section of the aorta and replace it with a surgical graft.  Post-operative and post-discharge recovery times are typically shorter with TEVAR, which may help patients return to their normal lifestyle routines far faster than for those who undergo open surgery.