Vascular Device Forum

New Applications for JetStream G2 from Pathway Medical threaten CSII, EV3

The Silverhawk device from EV3 and the Diamondback (Cardiovascular Systems Inc csii) now have additional pressure from the Jetstream G2 (Pathway Medical Technologies Inc) which has recently received 510 (k) clearance for removal of thrombus (mechanical thrombectomy) on the upper and lower extremities.

This represents a significant theoretical competitive advantage for the Jetstream G2 which now has multiple FDA approved applications for the treatment of Peripheral Arterial Disease (PAD).

From Medical News Today           

Pathway's newest peripheral atherectomy catheter, is capable of treating the entire spectrum of disease found in patients suffering from PAD, including hard and soft plaque, calcium, fibrotic lesions and thrombus, with consistent results

 

Jetstream G2 consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has an expandable cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. A highly efficient aspiration port located just proximal to the cutting blades continually removes excised tissue and thrombus from the treatment site to a collection bag located on the console. A fully recessed masticating system within the aspiration port helps break aspirated material into smaller pieces before removal. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. Active aspiration is a safety feature that minimizes the risk of distal embolization.

With simple set up and an ergonomic design for easy operation by trained clinicians, Jetstream G2 maximizes treatment effectiveness. Jetstream G2 offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

The Atherectomy Space has over a short period of time rapidly evolved with iterations on the first generation Silverhawk device to the current JetStream which has multiple applications (atheroma, calcium, thrombus) with a single device. Although, I dont personally have experience with this G2 system, It's clear that if the device behaves as touted, it may be a revolutionary advance.

 

 

CSI Replidyne Reverse Merger- Life for the Diamondback

Title CSI Replidyne Reverse Merger- Life for the Diamondback   Cardiovascular Systems CSI on the verge of an IPO in late 2008 announced an agreement on Nov 3, 2008 to undergo a reverse merger with Replidyne, a biotech company which failed in FDA phase III trials of its trial compound-faropenem. To learn more about other options for CSI and Replidyne On Feb 25, 2008 the two companies announced completion of the transaction. Cardiovascular Systems Inc as the new company will be called, now enters the public trading domain as CSII. In this transaction, Replidyne provided $37 million in net assets primarily cash for a 17% state in the post merger entity.   The diamondback athrectomy device is the company's core product. Athrectomy, a technique of shaving down atherosclerotic debris within a diseased and blocked blood vessel, is an minimally invasive alternative to angioplasty and stenting. Currently, it is FDA approved for usage in the peripheral circulation of the lower extremities. Future applications for the heart coronary system may be conceivable with further research and development   The merged company will be headed by the management team of CSI lead by David L Martin, CEO.  The combined board of directors consists of nine members, including two directors from Replidyne, Edward Brown and Augustine Lawlor. Glen D. Nelson, M.D., is chairman of the board. Other directors are Brent Blackey; John Friedman; Geoffrey Hartzler, M.D.; Roger Howe, Ph.D.; David Martin; and Gary Petrucci.   As of Dec. 31, 2008, more than 14,700 devices had been sold to approximately 400 hospitals since the September 2007 product launch. This is fantastic news for the CSI team. It seems to offer them some vital capital at a juncture when they may need to refill the tank for infrastructure, sales and marketing. As you know, Mr Martin, was former COO of Foxhollow and was instrumental in launching the Silverhawk device, an early generation peripheral atherectomy system that gained significant market share before the company was acquired by EV3. In its quarterly report, EV3 estimates that revenue from the Silverhawk device is 75% from peak activity. Several questions come to mind. (1) Is there medical evidence to support the benefit of athrectomy in the peripheral vascular system. The Diamondback system is touted as a solution for treating athero-occlusive blockages associated with heavy calcification. A problem that has previously challenged the techniques of balloon angioplasty and stent placement in the lower extremities. To date, there is limited research to support the benefit of angioplasty, stenting or atherectomy when compared to the gold standard of peripheral surgical bypass with autogenous vein. (2) At this point in athrectomy technology, is the diamondback system just a new variant of the silverhawk--marketed to have technical advantages in the relatively smaller segment of peripheral vascular patients who have dense calcification that is prohibitive for angioplasty and/or peripheral bypass. My guess is that the CSI will market the Diamondback as the "must have" new product to cardiac catheterization labs and soon market watchers will see a brisk climb in revenue from new accounts. Especially after the CSI Replidyne merger creates a fresh capital infusion to flood the market with an incentivized sales force and marketing support. But, where is the randomized prospective research data that will support wide spread application of the system by multiple specialist (The "Holy Grail" of long term device success)?? Or is the CSI Diamonback detined for the same face as the EV3/Foxhollow Silverhawk device-Brisk sales from new accounts only to collect dust on the back shelf of the cath lab as proceduralist lose interest for the newest toy  and ask for the familiar balloon, stent or surgical knife.

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

Boston Scientifics Wallstent receives FDA approval

The FDA has granted approval for Boston Scientific's Wallstent, monorail endoprosthesis. Three years have elapsed since results from the BEACH trial summarized outcomes associated with the use of the Wallstent. Since that time devices from Abbot, Cordis, EV3 and the NextStent from Boston Scientific have received approval. The device landscape or carotid stents is crowded. Even in the context of CMS limiting reimbursement to greater than 70%, symptomatic lesions. So although the relative population of treatable patients is static, the available devices has expanded

Positive Results with Abbot's Bioabsorbable Stent

October 13, 2008 -- Abbott (NYSE: ABT) today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries. Patients who received Abbott's bioabsorbable drug eluting coronary stent and were followed out to two years experienced no stent thrombosis out to two years and no new major adverse cardiac events (MACE) between six months and two years. These results confirmed earlier positive one-year clinical results with Abbott's bioabsorbable drug eluting stent. The results were presented today at the Cardiovascular Research Foundation's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium

Cook begins peripheral drug eluting stent trial

Cook Medical of Bloomington Indiana has completed enrollment in a clinical trial to assess the outcomes of drug eluting stents in the peripheral circulation. This places Cook at the forefront of peripheral device companies poised to bring drug elutin stent technology to the peripheral circulation. The trial of the ZilverPTX (zilverPTXtrial.com) uses paclitaxel coated nitinol stents to treat the SFA.

Cook has licensed the right to use a proprietary technology which binds the drug to the stent without the assistance of a polymer which may theoretically lessen the risk of allergic reaction.

Michael Dake MD, Professor of Radiology at University of Virginia health system is the primary investigator for the study and the results were released at SVS 2008

Drug Eluting Stent Taxus fails to show superiority

From the European desk of Medical Device Daily, the results of the Syntax Study presented at the congress of the European Society of Cardiology has left cardiologists scratching their heads and stent manufacturers searching for a believable spin. In the end, the Syntax Study failed to show non-inferiority for DES (Drug Eluting Stents) vs open Coronary revascularization.

The study involved the Taxus stent from Boston Scientific with a primary endpoint of death, stroke or myocardial infarction

Source

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.

How do we identify the vulnerable Plaque

One of vascular imagings largest obstacles is identification of the vulnerable plaque. Unfortunately the current gold standard of imaging, digital angiography is largely anatomic in its value. Not physiologic. The ideal modality would allow us to detect the plaque that has characteristics that are identified to be closely associated with plaque rupture. Plaque rupture is the event which typicall leads to vessel occlusion and acute ischemia in the brain or heart. The event usually involves rupture of unstable lipid-laden material which is followed by platelet aggregation and in severe case, thrombus adherence. If one is lucky, the entire lumen of the blood veseel is not completely occluded.

Various modalities like ultrasound have identified characteristics of plaques that are more consistent with embolization like heterogenicity. Cardiac Interventions Today presents a review article discussing current investigational modalities in this important area of plaque characterization

Source

Cordis Outback Re entry device for Chronic Total Occlusion Recalled

This just in. I was doing an endovascular case today in a patient with a chronic total occlusion (CTO)  of the femoral artery. After crossing the total occlusion, I needed to re enter the true lumen after being unsuccefful with my glide wire (Terumo) and Quik Cross (Spectranetics). I called for my "go to tool" which is my device of choice for me in this cirumstance. Only to find out that Cordis Endovascular/Johnson and Johnson has pulled the Outback re entry device from the market. More information will be forthcoming, however it appears that this is a proactive voluntary recall because of a .27% incidence of failure of the piercing needle component to safely retract. I'll corroberate that information in future posts.

The description of the event that triggered the recall was previously described in an FDA post in March, 2007.

For more information about chronic total occlusion (CTO) and methods of intervening upon these challenging lesions read this review article at vascular disease management.

The question that arises is will this affect level of success for CTO treatment because this is a commonly used device or will alternative devices such as the Pioneer device (Medtronic Vascular) fill the void.

Top Ten Cardiovascular and Peripheral Vascular Early stage companies

Vascular Device Forum (VDF) cites an article in Medical Device Today which describes the top ten early stage Cardiovascular and Vascular companies. This list was created from presentations at the "Investment In Innovation (In3) Medical Device Summit" on June 17-19, 2008. (Part 1 of 3)

1) Arterial Remodeling Technologies tops the list. Arterial Remodeling Technologies (“ART”) is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. Many industry experts are calling ART the next best thing.

2) CardiAQ Valve Technologies

3) ES Vascular technologies develops vascular staplers for open, endovascular AAA and femoral popliteal reconstructions.

7) Protomed creates sutureless techniques to facilitate rapid and safe completion of vascular anastomosis