[Congressional Record (Bound Edition), Volume 147 (2001), Part 7]
[Extensions of Remarks]
[Pages 9840-9841]
[From the U.S. Government Publishing Office, www.gpo.gov]



           ANOTHER MINNESOTA MEDICAL TECHNOLOGY SUCCESS STORY

                                 ______
                                 

                            HON. JIM RAMSTAD

                              of minnesota

                    in the house of representatives

                          Friday, May 25, 2001

  Mr. RAMSTAD. Mr. Speaker, the front page of the Wall Street Journal 
yesterday announced the Food and Drug Administration's approval of a 
break-through medical device produced by St. Jude Medical, and company 
located in my home state of Minnesota.
  St. Jude is part of Minnesota's Medical Alley, made up of 300 medical 
technology companies in the Twin Cities area, which has led the 
innovation explosion in health care. Increasingly, new medical devices 
are saving lives, improving the quality of life and reducing health 
care costs for Americans.
  Congress can be proud of its work over the past several years to 
reform the FDA so Americans can get access to life-saving medical 
technologies. However, much more remains to be done, including 
reforming the way Medicare reimburses seniors for these health care 
technologies.
  As co-chair of the House Medical Technology Caucus and a member of 
the Ways and Means Health Subcommittee, I encourage my colleagues to 
join me in promoting reforms that will make technologies like St. 
Jude's ``sutureless'' heart surgery device available to seniors and the 
other Americans who desperately need them.

              [From the Wall Street Journal, May 24, 2001]

     New Tools May Make Heart-Bypass Surgery Quicker and Less Risky

                            (By Ron Winslow)

       Berne, Switzerland.--As Thierry Carrel stands over his 
     patient in operating room No. 1 at University Hospital here, 
     he may be poised at the threshold of a new era in heart 
     surgery.
       For more than three decades, surgeons have used needle and 
     thread to sew new blood vessels into patients during 
     coronary-bypass operations, which are typically performed 
     through a massive incision in the chest. The vessels are used 
     to reroute blood around blockages in the arteries that feed 
     the heart. And the procedure's success hinges largely on the 
     surgeon's skill at stitching them into place.
       But at the moment, Dr. Carrel isn't using his sewing 
     talents. Instead, he takes a device loaded with a vein, 
     inserts it into a small hole he has just cut in the patient's 
     aorta and pushes a button. Click. The device, which resembles 
     a long-handled screwdriver, releases a tiny web of wires that 
     unfolds to form a star-shaped rivet. In less than 10 seconds, 
     Dr. Carrel has attached the vein to the aorta mechanically. 
     That compares with the three to five minutes it might have 
     taken him to make the same attachment with stitches.


                             Foreign Debut

       Dr. Carrel is one of a handful of surgeons in Europe and 
     Canada who have used the device during the past several 
     months on a total of about 1,000 patients. St. Jude Medical 
     Inc., the U.S. company that makes the product, rolled it out 
     quietly in Europe last fall, but has largely kept it under 
     wraps. Now, that is about to change.
       Today, St. Jude plans to announce that the Food and Drug 
     Administration has approved the device for use in the U.S. 
     That makes the St. Paul, Minn., company the early front-
     runner in an emerging race to equip doctors to perform 
     ``sutureless'' bypass surgery. If surgeons embrace the new 
     technology, it could transform the procedure by triggering 
     wider use of techniques designed to make the operation easier 
     on the patient and reduce the incidence of serious side 
     effects.
       St. Jude calls its new product the aortic connector. While 
     it is designed to make just one type of the various critical 
     attachments that bypass surgery requires, the company is 
     planning to introduce a full line of connectors over the next 
     year or two, aiming to automate the entire vessel-grafting 
     process. The typical bypass operation involves three or four 
     vessel grafts in which a doctor performs five to seven 
     individual sewing procedures.


                        Not Going to Fly Anymore

       As the first to the market, St. Jude faces several hurdles 
     in winning acceptance of its device. Among them: the added 
     cost of using it and the long-term track record of 
     conventional heart surgery, which is impressive enough that 
     many doctors may feel little need to meddle with it. But 
     there also are compelling arguments for heart surgeons to 
     adopt sutureless connectors. Leading the list is the growing 
     push to make bypass surgery--one of medicine's most invasive 
     operations--more patient-friendly.
       ``For 35 years, we've been doing by-pass surgery the same 
     way and gotten away with it,'' says Hani Shennib, a heart 
     surgeon at McGill University Health Center in Montreal. 
     ``That's not going to fly anymore. Patients really want to 
     have the same outcome as surgery but with procedures that are 
     a lot less invasive.''
       The most promising strategy along those lines is beating-
     heart surgery, in which the surgeon operates on the heart as 
     it continues to pump blood. The goal is to avoid putting the 
     patient on a heart-lung machine, or the ``pump,'' as surgeons 
     call it. Time on the pump, which takes over the heart's 
     function so surgeons can operate on a still organ, has been 
     associated with complications arising from bypasses.


                            A Moving Target

       But the beating-heart technique, which emerged in the mid-
     1990s, is used in only about 20% of the more than 700,000 
     bypass surgeries performed world-wide each year. The main 
     reason: the painstaking work of suturing bypass vessels into 
     place--which surgeons call ``the anastomosis''--is much 
     harder to do on a beating heart. Devices that automate the 
     process could make beating-heart surgery much less 
     challenging and potentially more popular.
       ``The only reason you put a patient on a pump is to 
     accommodate the guy tying the knots,'' says St. Jude's Daniel 
     J. Sullivan, the aortic connector's chief inventor. ``We're 
     the first ones to go after the sewing process as an issue.''
       In addition, proponents say, mechanical connectors could 
     make bypass surgery safer by reducing the risk of stroke and 
     other neurological side effects that recent studies have 
     linked to the operation. In February, Duke University 
     researchers reported that 42% of bypass patients suffer such 
     problems as loss of memory, confusion and inability to

[[Page 9841]]

     pay attention for as long as five years after the surgery. 
     About 3% of bypass patients suffer a debilitating stroke as a 
     result of the procedure. Some doctors say a connector could 
     help doctors avoid clamping the aorta, a step in the surgery 
     that is believed to be a key cause of such brain damage.
       Another potential benefit: consistency of surgical results. 
     ``Hand-sewn bypass grafts are irregular. Every one is a 
     little different,'' says Robert Emery, a Minneapolis heart 
     surgeon who served as a paid consultant to St. Jude in 
     developing its device. ``With this thing, every one is the 
     same.''
       St. Jude isn't alone in seeing a big opportunity for such 
     technology. Johnson & Johnson, in a venture with Bypass Inc., 
     of Israel, has tested a ``suture-less anastomotic device'' in 
     small-scale human trials. J&J says it has begun discussions 
     with the FDA about what would be required to gain approval. 
     Tyco International Ltd.'s U.S. Surgical unit and Abbott 
     Laboratories' Perclose unit both are developing mechanical 
     connectors, as are several smaller closely held companies.
       ``A lot of people think this is going to be a big deal in 
     coronary surgery,'' says Dr. Emery.
       In the U.S., St. Jude plans to sell its new device only to 
     hospitals whose surgeons have been trained in its use. As a 
     result, the company, which had $1.18 billion in revenue last 
     year, is projecting to sell only a few million dollars worth 
     of the connectors this year. In years ahead, St. Jude hopes 
     the devices will become a major contributor to its revenue 
     and profit growth.
       The St. Jude product includes a cutter that makes a round 
     hole in the aorta for attaching the replacement vessel, 
     rather than the jagged opening left by the punch that 
     surgeons now typically use for that job. The wire rivet that 
     the device deploys is made of a stable metal and is designed 
     to expand slightly to fill the hole as it clamps the vessel 
     to the aorta.
       But St. Jude must persuade surgeons that the device will 
     match or improve on the success rate of conventional bypass 
     surgery. Death rates from the procedure are only about 3% at 
     most hospitals. For the vast majority of patients, the 
     surgery is an effective treatment for angina, the severe 
     chest pain caused by blocked coronary arteries. And it could 
     take several years to show whether mechanical vein 
     attachments are as durable as sewn ones.
       Even the product's fans say that its cost could be a 
     deterrent, because issuers usually pay doctors and hospitals 
     a fixed amount for bypass operations. St. Jude plans to 
     charge between $400 and $450 for the single-use devices. 
     Assuming a full line of connectors becomes available, that 
     could add more than $2,000 to the cost of a typical bypass 
     operation. St. Jude says that shorter operating times and 
     other savings will partly offset the additional cost.
       A device that diminishes the value of a surgeon's suturing 
     skills could be hard to sell to some members of a profession 
     in which ``good hands'' are a hallmark of stature. ``Doing 
     the anastomosis is the essence of our specialty,'' says David 
     Fullerton, chief of cardiothoracic surgery at Northwestern 
     Memorial Hospital in Chicago. During his decade of surgical 
     training, Dr. Fullerton says he would hone his technique 
     during off hours by tying surgical knots in his shoelaces, 
     and by slicing open chicken breasts and sewing them up before 
     popping them on the grill.
       ``For most of us, it took so much effort to acquire these 
     skills, we're reluctant to give them up,'' he adds.
       That isn't to say that St. Jude's device will banish 
     sutures from the operating room anytime soon. For one thing, 
     the new connector is designed only for attaching saphenous 
     veins--replacement blood vessels that are harvested from a 
     patient's leg--and then only to attach the end of the vein 
     upstream from the blockage being bypassed. For now, surgeons 
     who use the device will need to stitch the other end of the 
     vein to an artery on the heart, below the obstruction.
       St. Jude is at work on a second device to make this lower, 
     or distal, connection. That's a trickier task for the surgeon 
     because there the diameter of the leg vein is typically much 
     wider than the vessel it is being connected to, requiring 
     special care to make sure the anastomosis doesn't leak. In 
     addition, that graft, which typically can take a surgeon 10 
     minutes to 15 minutes to complete, often must be connected to 
     harder-to-reach areas on the side or back of the heart.
       In Berne, Dr. Carrel and his colleague Friedrich Eckstein 
     have used St. Jude's distal connector in about 20 patients so 
     far, with encouraging results. St. Jude says it hopes to have 
     this second device on the market in the U.S. by mid-2002. 
     Among other things, it is designed to eliminate the problem 
     of mismatched vessel diameters.
       Another model the company is developing would come into 
     play when doctors use the internal mammary artery, located in 
     the chest wall above the heart, as a bypass vessel. Surgeons 
     often use that artery for by-passing the artery that feeds 
     the heart's pumping chamber. Still another version of the 
     device is aimed at the growing number of surgeons who prefer 
     to use the radial artery taken from the arm as a bypass 
     vessel.
       St. Jude is counting on the line to transform it into a 
     major player in the cardiac-surgery market. The company has 
     long dominated the heart-valve market, and it also sells 
     devices that combat heart-rhythm irregularities. But in the 
     late 1990s, its executives launched a search for new 
     technologies that promised future growth.
       That search led to St. Jude's surprise announcement a year 
     and a half ago that it was acquiring Vascular Science Inc., a 
     closely held Minneapolis company that developed the connector 
     under Mr. Sullivan's leadership. St. Jude paid $80 million 
     for VSI and agreed to pay an additional $20 million if the 
     newly acquired unit met certain development goals. But though 
     the acquisition substantially diluted its earnings, St. Jude 
     largely kept mum about what it was buying.
       ``We didn't want Guidant, Medtronic, Boston Scientific and 
     every cab driver in New York making these things,'' says 
     Terry L. Shepherd, St. Jude's president and chief executive, 
     referring to rivals in the heart-device business.
       Some doctors who are impressed by the device believe it 
     won't win broad acceptance until a distal connector is 
     available, so that surgeons can do both ends of their grafts 
     without sutures.
       However, St. Jude believes there is a robust market for the 
     aortic connector alone, thanks in large part to its potential 
     for reducing neurological side effects from surgery. During 
     conventional bypass operations, when the heart is stopped, 
     doctors clamp off the aorta to keep blood from backing up 
     into the heart. But in patients with clogged coronary 
     arteries, the aorta if often diseased too. That means its 
     lining is layered with plaque, much like a rusty pipe. When 
     the aorta is clamped, some of this gunk can be dislodged. 
     When the clamp is released, the debris is picked up in the 
     blood stream and can get carried to the brain.
       ``You get an old guy whose vessels look like a Drano 
     commercial, and sometimes you hear an audible crunch'' when 
     the clamp is applied says David Stump, a researcher at Wake 
     Forest University, in Winston-Salem, N.C., who has studied 
     the neurological side effects of heart surgery.
       Material dislodged by clamps is believed to be one of the 
     chief causes of brain-related side effects in bypass 
     patients. In extreme cases, it can cause a major stroke, or 
     even death. Just how serious and lasting the effects are 
     depends on where in the brain the debris ends up, says Dr. 
     Stump.
       During beating-heart surgery, blood continues to flow 
     through the aorta. But doctors use what they call a side-bite 
     clamp to pinch off a portion of the vessel to stabilize the 
     site for stitching. That, too, entails a risk of dislodging 
     debris, and other complications. But with the connector, 
     doctors will be able to connect vessels quickly enough to 
     make such clamps unnecessary.
       ``The first and immediate impact of the St. Jude device is 
     that you don't have to put a clamp on the aorta,'' says 
     Michael Mack, a Dallas heart surgeon with no financial 
     connection to the company. ``That eliminates a potential 
     source of stroke.''
       Whether that will prompt widespread use of the device is 
     hard to gauge. Neurological problems can be caused by factors 
     other than clamps, and St. Jude doesn't have any data as yet 
     to demonstrate whether its device indeed cuts the risk of 
     stroke or cognitive impairments. But with the neurological 
     issue getting fresh attention, many doctors may not feel 
     inclined to wait for hard data. ``If you have a patient with 
     a brain problem after an [otherwise] uncomplicated operation, 
     that is disastrous,'' says Dr. Carrel, the Swiss heart 
     surgeon.
       Five years ago, when Mr. Sullivan and a small group of 
     engineers started thinking about the connector, their goal 
     was to develop technology for doing bypass surgery through 
     the same type of catheters used in balloon angioplasty. In 
     the angioplasty procedure, a balloon-tipped catheter is 
     threaded through a small incision and into the heart, then 
     inflated to open a blocked artery. But early on, it became 
     clear that using sutures to attach vessel grafts via catheter 
     wouldn't work. That set off the plan to develop a mechanical 
     connector for conventional bypass surgery.
       Still, Mr. Sullivan and others believe that the new 
     technology will lay the groundwork for their original plan, 
     eventually enabling doctors to do bypass surgery without 
     cracking open the patient's chest.

     

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