Vascular Device Forum

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."

 

Cardiovascular Systems Inc CSII Organizational Shake Up

Cardiovascular Systems Inc (CSII)fresh off their merger with Replidyne is scheduled to release their Q3 earnings on May 6. The Executive management team has recently undergone some changes and their are rumors that the sales force reps have been forced into a lower commissioned performance arrangement.

A new collaborative distribution agreement with Invatec was presented as a way to enhance the portfolio of CSII. The CSII sales force will now distribute a small vessel platform of PTA balloon, one of which is the amphirion .014 system. It seems like where this is headed is now the physician will be encouraged to follow athrectomy with the diamondback with PTA using one of this series of balloons. Thats somewhat odd since the premise of athrectomy is that its better than PTA. That would seem to be a bait and switch to say that PTA is no good so use our diamondback athrectomy device and then after you use it, now that we carry balloons- just touch it up with one of our very effective balloon products. It all adds up to a costly intervention with as yet unproven benefit

From Tradingmarkets.com

Cardiovascular Systems, Inc. (CSI), a medical device company developing and commercializing interventional treatment systems for vascular disease, announced that Brian Doughty has been promoted to vice president of commercial operations from vice president of marketing, and Scott Kraus, previously a senior sales director, has been named vice president of sales.

Doughty and Kraus will assume responsibilities previously performed by John Borrell, who has left the company to pursue other opportunities. Additionally, the company announced that Dr. Nabil Dib, MSc, FACC, has been appointed to serve as medical advisor to CSI.

"These promotions recognize the outstanding work and abilities of Brian and Scott," said David L. Martin, CSI president and chief executive officer. "Together, they have nearly 30 years of medical device industry experience. They have the skills, experience and drive to implement marketing and sales strategies to accelerate adoption of our Diamondback 360 degrees Orbital Atherectomy System for peripheral arterial disease, as well as lead a growing national sales organization of over 100 professionals. We also want to thank John Borrell for his many contributions to CSI. John played an important role in building our sales organization and launching our Diamondback 360o system."

Doughty came to CSI in November 2006 as director of marketing and was named vice president of marketing in August 2007. Prior to joining CSI, he served as director of marketing at EKOS, a manufacturer of an endovascular treatment system for vascular clots; before that, he worked in practice development at FoxHollow Technologies. In addition, he held various sales and sales management positions at Medtronic and Johnson & Johnson.

Kraus has been with CSI since September 2006, most recently as a senior sales director. Previously, he held sales management positions with Boston Scientific Corp., Guidant and C.R. Bard. Earlier, he gained sales experience at C.R. Bard, Bristol-Myers Squibb and Surgical Specialties Corp.

Dr. Nabil Dib to Serve as Medical Advisor 

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Medtronic Starts Enrollment in THRIVE, U.S. Post-Market Study of the Talent™ Thoracic Stent Graft Lifesaving Medical Device Extends Benefits of Minimally Invasive Endovascular Repair of Aortic Aneurysms to More Patients

related stories: Drug-Eluting Stent Center FDA Approves Talent Thoracic Stent Graft external sites: Medtronic, Inc. Talent Thoracic Stent Graft     April 27, 2009 -- Minneapolis -- Medtronic, Inc. (NYSE: MDT), today reported the start of THRIVE, the company’s U.S. post-market clinical study of its Talent Thoracic Stent Graft for the endovascular repair of thoracic aortic aneurysms. The acronym THRIVE stands for Descending Thoracic Aortic Aneurysm Endovascular Repair Post Approval Study An aortic aneurysm is a dangerous bulge or weakness in the body’s main artery. Untreated, aortic aneurysms can burst, commonly resulting in death due to extensive internal bleeding. Thoracic aortic aneurysms affect nearly 10 of every 100,000 elderly people in the United States. Thoracic endovascular aortic repair (TEVAR) is a minimally invasive procedure in which a stent graft – a fabric tube reinforced with metal springs – is threaded through the femoral artery and expanded at the site of the aneurysm. Once in place, the stent graft creates a new path for blood flow, reducing pressure on the aneurysm and the risk of rupture. The alternative to TEVAR is open surgical repair. Addressing a condition of U.S. Food and Drug Administration (FDA) approval, THRIVE will enroll a total of 451 patients at a minimum of 15 U.S. sites. The study’s primary endpoint is freedom from aneurysm-related mortality (ARM) at five years, with ARM defined as death from aneurysm rupture or from any procedure intended to treat the segment targeted by the Talent Thoracic Stent Graft System. The study design incorporates the test group of 195 subjects from the earlier study that supported the device’s FDA approval in 2008, as well as an additional 256 new subjects to be prospectively enrolled. All subjects will be followed for five years.

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CSII Cardiovascular Systems Quarterly Call-Diamondback device

Cardiovascular Systems (CSII) has its quarterly report on May 6. Recently the company has undergone some organizational changes. As you probably know, CSII went public via a merger with Replidyne in February of 2009 (see VDF post regarding the merger). The 2nd quarter results, released just days before that merger demonstrated strong revenue growth over the prior ytd.

I think its a fascinating story of a small niche device company navigating the choppy waters. I've received a great deal of feedback about CSII, their Diamondback Atherectomy device as well as feedback on the best known first generation Athrectomy system The Silverhawk (formerly of Foxhollow fame and now EV3). The feedback has come from the end user physicians including interventional radiologists, cardiologists and vascular surgeons.

Today, I would like to raise a couple of issues of concern. This will be a several part post on this interesting technology. First, Im interested in the lack of evidence that bolsters the effectiveness and clinical utility of this technology. The Diamonback is formally positioned as the only option for the percutaneous treatment of calcified, infra popliteal calcified arterio-occlusive disease. The premise is that angioplasty and stenting of these vessels has marginal results in the presence of calcium. Technically, the diamondback from CSII has a diamond impregnated crown which applies a differential sanding effect as the crown rotates at 60-200,000 RPM

Practically speaking, all calcified arterial lesions are not resistant to PTA. In my opinion, only the most moderately severe to severe calcified lesions are refractory. And in my experience, these lesions tend to be associated with total occlusions and long segmental disease. Coupled with calcium, both of these features are challenging for Diamonback technology just as much as they are with angioplasty or any other available modality. What Im suggesting is that the mild and moderately calcified lesions which the Diamondback treats, are likely amenable to PTA. Until I see patency comparisons, it's is difficult for me to think otherwise

Additionally, I have concerns that the shift in the field will be to encourage the use of the device in the non calcified, atherosclerotic lesions and I think this practice has unclear consequences including diminished efficacy and potential issues of distal embolization (the fracture of particulate material that migrates into the small vessels and lodges in those arteries causing pain and perhaps ulceration

Next, the premise that the use of this Diamondback system in the above knee space (which is a more frequent and commonly treated pattern) has limited benefit over the currently available technology. (PTA, bare metal stent, covered stent, directional athrectomy). I believe that the projection that this above knee space is potential future market share is lacking in evidence based upon this impracticallity.

Finally, every device company has the R&D pitch that their device will work in the much larger coronary space and that future iterations will allow that market to be captured. (the conference call investor pitch about future growth). Ask any knowledgeable person if they believe that EV3 will develop Silverhawk technology to the point of wide spread use in the treatment of coronary or carotid disease? Im guessing that the answer will be resoundingly No.

In my opinion, its quite easy to select vascular lesions which have favorable characteristics to make a device safety and feasibility acceptable, however, it's the real world use of the technology by the high volume end user which determines if technology will be a long term major player in a vascular space as opposed to the "flash in the pan" newest "toy" only to be relegated to dust collecting section of the cath lab.

It seems to me that one of the main differences in the roll out of the Diamondback compared to the Silverhawk system is that Foxhollow had a much more dramatic direct to patient marketing and advertisement effort. To the extent, that physicians really felt compelled to have the technology in the Toolbox because patients were calling to ask if hospitals and physicians have it. I dont see that penetration into the physician community or into the lay community with the diamondback. Perhaps it's because their salesforce is significantly smaller.

Currently, the Diamondback device from CSII is on a trajectory to follow the Silverhawk system. New niche technology roled out as the next best tool for vascular disease. Trial adoption by members of the cardiovascular, interventional radiology and vascular surgery community. New physcians, new hospital accounts to grab some market share of the 8-12 million and growing PAD patient population. Several physicians (with options) touting the benefit in the absence of any substantial evidence based support from unbiased randomized prospective studies by broad group of physicians competent with all technologies.

If this data is eventually collected and presented to demonstrate advantage to the use of diamondback technology in the infrapopliteal space, I will be very happy. The disease pattern is challenging and patients would benefit tremendously from effective technology.

David L. Martin, president and chief executive officer of CSI, and Laurence L. Betterley, chief financial officer, will discuss the company's results for the fiscal third quarter ended March 31, and outlook for the remainder of the fiscal year.

To access the live webcast, go to the investor information section of the company's Web site, csi360.com, on the day of the conference call and click on the webcast icon. A webcast replay will be available beginning at 7 p.m. CT the same day.

To participate in the conference call, dial (888) 713-4214 and enter 26726197. Please dial in at least 10 minutes prior to the call. Participants may pre-register online for the call by logging on to the following Web site: theconferencingservice.com/prereg/key.process?key=PVLJH9LB3

If you do not have access to the Internet and want to listen to an audio replay of the conference call, dial 888-286-8010 and enter access number 71489482. The audio replay will be available beginning at 8 p.m. CT on Wednesday, May 6, through 6 p.m. CT on Friday, May 8.

Cardiovascular Systems is a medical device company focused on developing and commercializing interventional treatment systems for vascular disease.

       

 

 

 

Specialty Wars Continue: Defibrillators and Electrophysiologist

I received an article from a good friend today from the New York Times. He's a liberal New Yorker (pronounced yakker) so he considers the the Times the equivalent of the Bible, Talmud or the Koran. The article comments on a recently published JAMA paper on complications with defibrillator implantation. It finds that patients who underwent defibrillator placement by a cardiologist subspecializing in electrophysiology (EP) have lowere complication rates compared when to implantations performed by non EP cardiologists, thoracic surgeons and others.

"Most implant procedures, about 70 percent, were performed by electrophysiologists, the study reported. The remaining implants were done by other types of cardiologists or other kinds of doctors, including thoracic surgeons. The study found that the highest rate of serious complications, about 2.5 percent, occurred when the implant was done by thoracic surgeons, who accounted for only 1.7 percent of the procedures reviewed.

In recent years, the question of how much training doctors receive before they start implanting heart devices has taken on added importance because of the growing number of people getting defibrillators. The units send out electrical jolts to disrupt potentially fatal heart rhythms. "

New York Times exerpt

There remains a lot of controversy about various specialty turf wars and who should be doing what procedure. This gets into areas like credentialling, training, industry relationships and hospital politics. This area of EP would seem to be a little more clear cut than, lets say peripheral arterial interventions where one sees cardiologists, vascular surgeons, interventional radiologists and now even interventional nephrologists competing.

One of the least debatable parts of this discussion is the fact that institutions have to define a minimal level of training to become credentialed for an area of procedures.  The credentialling should be evidence based to include representation from various involved specialties. Furthermore, the literature is clear that their is a direct relationship not only with physician volume but with hospital volume and better outcomes. I dont care who does the procedure, if they have been trained well and currently perform a high volume, then they are likely to better outcomes.

Im encouraging various specialists to share their turf battle stories with www.vasculardeviceforum.org  . It's an interesting topic that is not soon to go away.

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Cordis -Johnson and Johnson- 50 year anniversary

Great article from PTCA.ORG describes the 50 year evolution of Cordis Corporation transorming cardiovascular care.  Cordis, a Johnson and Johnson company, has been a leading innovator in cardiovascular care

Humble Origins, Numerous ‘Firsts’
Cordis was founded in 1957 in a garage in Miami, Florida, by Dr. Murphy, the son of a Nobel laureate. The company, originally named Medical Development Corporation, rapidly gained recognition as a pioneer in innovative products for interventional vascular medicine. In 1959, Dr. Murphy changed the company’s name to the more distinctive Cordis ("of the heart"), indicating its primary therapeutic focus.

During the 1960’s, Cordis became involved in the relatively new field of cardiac pacing and also introduced the first full line of “pre-shaped” Judkins catheters, invented and perfected by Dr. Melvin Judkins, to simplify catheter insertion by using a pre-formed catheter into the femoral artery in the groin. This approach rapidly caught on, virtually replacing the semi-surgical Sones brachial technique. Visit PTCA.org to read the full article Source