Vascular Device Forum

Will Definitive leave Silverhawk Atherectomy (EV3) Dead in the Water

The Definitive Trial for atherectomy was intiated in April 2009 to evaluate the efficacy of the Silverhawk Atherectomy Device from EV3. The Silverhawk technology emerged on the scene to much fanfare with an aggressive marketing strategy in the early part of the decade. At that time, there was very little clinical data to support benefit of the device versus the available clincal alternatives POBA, Stent and surgical bypass.

Aggressive marketing toward groups like podiatrists endeared the technology and sealed its role in the treatment of PAD. Almost 10 years later, there is still little information available about the benefits of the technology outside of centers who tout excellent results with high volume useage. (
See Dr Mckinsey's comments by clicking here

Unfortunately, most patients are treated outside of high volume centers that have practitioners with well developed experiences and judgments about this technology. At this point, I believe that the 80/20 rule is in effect. The low volume guys hae virtually stopped using the technology and the high volume guys ie 20% of proceduralist are responsible for 80% of the volume and company revenue.

The question I raise is will the definitive trial answer questions and resolve the dilemma to establish a role for Silverhawk Atherectomy or will it leave Silverhawk technology and EV3 dead in the water. Im sure that competitors wait anxiously. ie  Diamondback from CSI and Jetstream G2 from Pathway Medical. If the results are good, they will piggy back off the results obtaining borrowed credibility from the study of atherectomy. If the results are bad, they will run for cover claiming a different atherectomy technique

Pathway Medical has new 7 fr Jetstream G2 for Atherectomy, Thrombectomy

Pathway Medical announced further iterations of the G2 device for Atherectomy and thrombus removal

 

PATHWAY MEDICAL TECHNOLOGIES INTRODUCES JETSTREAM G2™ NXT

 

 Smaller 7 French Compatible Atherectomy Catheter Now Available to Treat Larger Patient Population

 

KIRKLAND, WA––August 10, 2009––Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral arterial disease (PAD), today introduced the 7 French compatible version of its peripheral atherectomy catheter. Jetstream G2™ NXT is based on the company’s state-of-the-art catheter technology capable of treating the entire spectrum of disease found in patients suffering from PAD, including hard and soft plaque, calcium, fibrotic lesions and thrombus. 7 French compatibility allows physicians to use Jetstream G2 NXT in the treatment of PAD in a more diverse patient population, significantly expanding the number of patients who can now benefit from this innovative technology. 

 

“The 7 French compatible Jetstream G2 NXT is nearly identical to Jetstream G2, but has the advantages associated with smaller sheath technology,” said Dr. Robert Bersin at Seattle Cardiology. “As such, it expands my ability to treat more anatomies and patients with varying degrees of PAD.”

 

Approximately 12 million Americans suffer from the effects of PAD and many in this rapidly expanding patient population go undiagnosed. Commonly associated with high blood pressure, diabetes, heart disease, stroke and aging, PAD causes a build-up of plaque within the arteries that limits blood flow to the extremities. PAD can lead to severe limb pain, non-healing ulcers and critical limb ischemia and, if left untreated, can lead to gangrene, amputation and even death. The most common intervention for PAD has historically included highly-invasive procedures, including bypass surgery. Unfortunately, many patients are poor surgical candidates for whom surgery can be life threatening. Atherectomy—the removal of the blockage by inserting a specialized catheter into the artery to remove the fatty buildup from the artery walls—has proven to be an effective, first-line option in minimally invasive PAD intervention. Yet, until now, atherectomy devices have not been effective in removing all types of hard and soft tissue plaque.

 

“Today’s news coupled with the recent FDA clearance to market Jetstream G2 for thrombus removal

underscores our unwavering commitment to provide new and better treatment options for the millions of Americans suffering from PAD,” commented Pathway Medical Technologies President and CEO Paul Buckman. “With the introduction of Jetstream G2 NXT, we are able to provide much needed atherectomy treatment to an expanded patient population.”

 

 

 

 

About Jetstream G2 NXT

Jetstream G2 NXT is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PAD.

 

Jetstream G2 NXT 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. 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 NXT maximizes treatment effectiveness and offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

 

About Pathway Medical Technologies, Inc.
Pathway Medical Technologies, Inc. was founded to design market and manufacture medical devices for the treatment of vascular disease. The company’s initial focus is treating peripheral arterial disease (PAD) more quickly and effectively than existing technologies. An estimated 12 million people are afflicted by PAD in the

U.S.

and that number is projected to grow to over 20 million during the next 10 years. The company’s Jetstream® device allows for a minimally invasive procedure designed to restore circulation in the peripheral arteries by removing both hard and soft diseased tissue. For further information, visit the company’s Web site at www.pathwaymedical.com.

Literature summary Silverhawk, Diamondback and Jetstream G2 devices

The major criticism of peripheral atherectomy continues to be "show me the data". The device companies counter with "we gave you what was necessary for approval... anything else is too expensive". EV3 has threatened that further studies are forthcoming. Until then, EVToday has a nice review article from Husami, Akhter and Lawrence Garcia at St Elizabeths in Boston.

Atherectomy in the Superficial Femoral Artery
An evidence-based approach for device selection, ideal applications, and cases to avoid.
By Wael F. Al-Husami, MD, FACC; Mohammed W. Akhter, MD; and Lawrence A. Garcia, MD, FACC, FAHA

Currently, there are multiple treatment strategies to address stenotic or occlusive atherosclerotic disease in the superficial femoral artery (SFA). Percutaneous transluminal angioplasty (PTA) results have traditionally been suboptimal and less durable, especially with longer-lesion subsets.^1,2 Self-expanding nitinol stents do not perform as well when considering long-term patency rates (after 2 years) based on recently published stent trials, even though they are accepted as the default therapy for treating the SFA.^3-5

Atherectomy in the peripheral vasculature has gained interest due to its perceived benefits over simple PTA. The theoretical avoidance of barotrauma and overstretch of the vessel wall is desirable and can prevent acute vessel recoil or dissection. These unwanted side effects can lead to restenosis or reocclusion in the treated vessel. However, it is unclear how often stand-alone therapy is done and what impact a "soft" balloon inflation after atherectomy may have with regard to patency rates.

more...Source

Pathway's Jetstream G2 up close and personal

I attended a single day conference focusing on atherectomy and the use of the Jetstream G2 atherectomy/thrombectomy device from Pathway Medical. I've posted quite a bit about the atherectomy space in vascular therapy. That's because, I think that it represents a critical phase of technology innovation in the treatment of infrainguinal PAD   Currently, all the available therapies are plagued by differing failure modes. Angioplasty, stenting and atherectomy have various mechanisms of failure at different intervals. And different therapies may selectively benefit various disease types. SFA disease represents a large challenge with various options for treatment. see sfa challenge   The Jetstream G2 represents the second generation of the Pathway device. It now has a thrombectomy indication which makes it quite appealing. In the demonstrations of the device, it performed remarkably well in the treatment of CTO's of the SFA. There is an emerging body of treatment philosophy that traversing CTOs intraluminally as opposed to subintimally will provide the best opportunity to utilize future technology such as drug eluting balloons and stents. With this in mind, the Jetstream was used in combination with the Crosser device (FlowCardia Inc., Sunnyvale, CA) which allows central crossing of the lesion.   In most cases, IVUS verified a concentric crossing of the total occlusion with a luminal size of 2.7-3.5 mm. The primary treatment with the Jetstream was complimented by low pressure balloon angioplasty.   The technology seemed to work very well in In Stent restenosis which has a very high recurrency rate with limited effective treatment modalities currently. Additionally, it proved highly effective at penetrating fibrocalcific plaque formation.   Treatement times were somewhat prolonged depending on the plaque mophology.   The advantages of the Jetstream over the diamondback from CSI appear to be the ability to treat longer lesions at one setting in less time with the same device. The Jetstream sizes from 2.1 up to provide flexibility and cost savings from using only a single catheter per treatment   Additional data will be forthcoming, however, I was pleasantly surprised at the results seen in the live demo cases

Pathway Medical Technologies Paul Buckman shares vision

I recently had the opportunity to speak to Pathway Medical's CEO Paul Buckman. In 2008, Pathway Medical Technologies received FDA approval for the Jetstream G2 for peripheral atherectomy. This was followed by approval for arterial thrombectomy in 2009. The Jetstream G2 enters an atherectomy field which features EV3's Silverhawk and CSI's Diamondback system.

Mr Buckman is a former protege of who some consider the father of atherectomy, John Simpson,former CEO of Foxhollow technologies. Mr Buckman recalled being hired by Simpson and learning some critical lessons of device development. Including the continual need to welcome feedback from the end user in an attempt of improve device function and patient outcomes. This important philosophy appears to be a cornerstone of the company culture at Pathway Technologies.

Mr Buckman brings a wealth of experience and corporate experience in the medical device space. From the Pathway Medical Technology website:

Paul brings more than three decades of medical industry leadership to Pathway Medical, where he recently served as chairman of the Board of Directors. He joined the company from Devax, Inc. where he served as chief executive officer and board member since December 2006. From August 2004 to December, 2006, Paul was president of the Cardiology Division of St. Jude Medical, Inc., a diversified medical products company. Prior to St. Jude Medical, he served as chairman of the Board of Directors and chief executive officer of ev3, LLC, a Minnesota-based medical device company focused on endovascular therapies that Paul founded and developed into an $80 million business. Paul’s 30 years in the medical device industry include 10 years at Scimed Life Systems, Inc. and Boston Scientific Corporation, where he held several executive positions before becoming president of the Cardiology Division in January 2000. Paul currently serves as a board member for SentreHeart, Inc and has held posts on the boards of Velocimed, Inc., where he was a co-founder, EndiCor, Inc., Microvena, Inc. and Micro Therapeutics, Inc. Source

On the financial side, Mr Buckman states that Pathway recently obtained a fresh round of cash infusion which allows them to focus on the busines at hand and sell some of the recently released devices. His company vision appears to be to create a strong peripheral vascular device with a broad range of device offerings. With regards to the landscape of the atherectomy space, Mr Buckman offers a view that there remain a large number of physicians who are not comfortable with atherectomy and the room for growth outside of the currently offered atherectomy devices is substantial. And the number of patients with infrainguinal disease treated with atherectomy is relatively small.

From the short conversation, it appears that Pathway is headed for years of success.

I encourage physicians using the pathway device to offer feedback on device function, current applications and future iterations

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.

 

 

Foxhollow/EV3 Silverhawk vs CSI Diamonback-More behind the scenes positioning

Vascular Device Forum (VDF) continues to get information on the allegations against former members of Foxhollow/EV3 management and sales force team. The allegations in the posted document refer to EV3/Foxhollow's misappropriation of trade secrets in addition to the allegations of opinion leader poaching that our post described yesterday.

Further allegations suggest that CSI attempted to gain unfair advantage by hiring members of Fpxhollow's management team who systematically obtained vital client relationship information prior to departing EV3 Foxhollow:

Immediately prior to Collins resigning his position at FoxHollow he required each FoxHollow Regional Manager then reporting to him to prepare and deliver to him a “business plan.” Collins’ superiors did not ask him to gather business plans from his direct reports. The business plans contained vital confidential information owned by FoxHollow including, but not limited to, sales information, revenue targets, lists of FoxHollow’s customers, Key Opinion Leaders (physicians who heavily utilize the SilverHawk™ device), target customers and marketing strategies. Given his impending departure, at the time Collins requested and obtained such business plans the only reason to collect this information was so he could use it at CSI to unfairly complete with EV3/FoxHollow.

It's clear that the potential for the application of atherectomy technology is enormous and the potential economic return is substantial. And the individual financial rewards for being the first in on a startup opportunity like CSI or Pathway medical are quite motivating

Read this section of the source legal document

Silverhawk, Diamondback CSI....now Pathway?

Pathway technologies received FDA approval for the newest atherectomy device to enter the crowded atherectomy space. The atherectomy space previously dominated by the likes of EV3's Silverhawk device and followed by CSI's Diamondback System, is now a crowded field. This makes things interesting because the Diamondback is barely out of the gate with its recent September 2007 release.

On June 30, 2007, Pathway Medical Technologies said that it has raised $24.5 million in venture capital from existing investors. Money geared to help the company create a sales force to launch

Pathway has some 100 employees. After receiving FDA approval, the company intends to expand as it creates a sales and marketing team, but Clement declined to say how many jobs would be created.

Diamondback Orbital Atherectomy from CSI erodes Foxhollow's marketshare with Silverhawk

It appears that the Diamondback from CSI has eroded into the marketshare for lower extremity atherectomy that was preveiously held by EV3/Foxhollow's Silverhawk. The Diamondback system is an orbital atherectomy device for treatment of lower extremity athero occlusive disease. It was released in September of 2007. CSI filed with the SEC for a planned IPO in January of 2008. See more information about the technique of orbital atherectomy with the Diamondback atherectomy from CSI. Learn more details about the executive team and corporate financials for CSI.

Read more about EV3/Foxhollows 2007/Q4 results. This article nicely summarizes some of the barriers to growth that exist with directional atherectomy using the silverhawk system.

So does this all add up to the successful IPO for CSI only 10 months after the FDA granted 510 clearance for the Diamondback device. 1,700 catheters were shipped and $4.6million revenue generated at the close of 2007 (see S1 SEC filing) In VIVO Blog reports why it makes sense.

Finally, Bio Medicine reports Q1 2008 results which further notes issues such as high levels of customary inventory. ie large volumes of product sitting dormant on hospital shelves, highly incentivived-highly compensated former silverhawk reps being brought in line with industry comp norms

Diamondback Orbital Atherectomy from CSI erodes Foxhollow's marketshare with Silverhawk

It appears that the Diamondback from CSI has eroded into the marketshare for lower extremity atherectomy that was preveiously held by EV3/Foxhollow's Silverhawk. The Diamondback system is an orbital atherectomy device for treatment of lower extremity athero occlusive disease. It was released in September of 2007. CSI filed with the SEC for a planned IPO in January of 2008. See more information about the technique of orbital atherectomy with the Diamondback atherectomy from CSI. Learn more details about the executive team and corporate financials for CSI.

Read more about EV3/Foxhollows 2007/Q4 results. This article nicely summarizes some of the barriers to growth that exist with directional atherectomy using the silverhawk system.

So does this all add up to the successful IPO for CSI only 10 months after the FDA granted 510 clearance for the Diamondback device. 1,700 catheters were shipped and $4.6million revenue generated at the close of 2007 (see S1 SEC filing) In VIVO Blog reports why it makes sense