BBI Contributing Writer

NEW ORLEANS, Louisiana – As had been anticipated, the events of Sept. 11 cut into attendance at this year's clinical congress of the American College of Surgeons (ACS; Chicago, Illinois), with only about 6,200 surgeons in attendance at the October gathering. That was a far cry from the typical 8,500 to 9,500 usually in attendance, but not a bad turnout considering that the events of Sept. 11 were not yet a month old.

Although most of the programs continued as scheduled, some speakers did not attend and a handful of courses were canceled due to low attendance. The last-minute cancellations provided an opportunity to discuss more timely topics such as sessions titled "Unconventional Civilian Disasters: What the Surgeon Should Know," "A Community Systems Response" and "Chemical and Biological Disasters – The Details" – none of which were on the original program, but were now considered to be important topics.

Breast disease management

What could have been the most significant new trend of the entire conference was that of minimally invasive breast disease management. Until now, the standard treatment for suspicious breast lesions was to remove them using an open surgical procedure. But with earlier detection and therefore smaller lesions, the demand from patients is for a more cosmetic outcome; and from this an entire new array of products has blossomed.

Breast cancer management has evolved from radical mastectomy in the 1950s to lumpectomy in the 1970s, to percutaneous lesion removal in the 1990s, to possibly ablation in situ in the new millennium. The momentum continues for those with benign disease as well. Some 85% of the 1.4 million breast biopsies performed in the U.S. annually turn out to be benign (see Table 1). Until now, most patients with benign lesions were advised to just watch carefully and return for more frequent checks. But with a better-informed patient, many want more than just a "wait and watch" protocol – they want the lesion removed, and with a cosmetic effect. These patients will soon have many new options for their breast disease management.

Table 1: Breast Disease Diagnosis
Number of Procedures Annually in the U.S.
Mammograms 32 million

Biopsies 1.4 million
Open surgical 650,000
Core needle 700,000
Fine needle aspiration 12,000

Benign masses removed 200,000
New cancer cases 192,000

Source: The BBI Newsletter

Breast disease management has recently been promoted partly due to the increased awareness of breast cancer and the benefits of early detection. In addition to the mainstay companies that have served this market, there are several early stage companies that have been formed to address particular segments of this now broader breast disease management market (see Table 2).

Table 2: Companies with Products in Breast Disease Management
Type of Product Company

Stereotactic Breast
Biopsy Systems
Ethicon Endo-Surgery (Cincinnati, Ohio)
Imagyn Medical Technologies (Irvine, California)
U.S. Surgical/Tyco Healthcare (Norwalk, Connecticut)
Fischer Imaging (Denver, Colorado)
GE Medical Systems (Livermore, California)
Suros (Indianapolis, Indiana)
Markers/Localization
Devices
Ethicon Endo-Surgery
SenoRx (San Juan Capistrano, California)
Sanarus Medical (Sunnyvale, California)
Vivant (Portola Valley, California)
Calypso (Seattle, Washington)
Digital Mammography Fischer Imaging
GE Medical Systems
Siemens Medical Systems (Iselin, New Jersey)
Trex Medical (Danbury, Connecticut)
Computer Assisted
Diagnosis
R2 Technology (Los Altos, California)
CAD-X (Toronto, Ontario)
Minimally invasive
excision or ablation
system
SenoRx
Senolase (Denver, Colorado)
Sanarus
Neothermia (Palo Alto, California)
Artemis (San Carlos, California)
Rita Medical (Mountain View, California)
Vivant (Portola Valley, California)
Celsion (Columbia, Maryland)
Rubicor (Redwood City, California)
Radiation Therapy
Delivery
Proxima Therapeutics (Alpharetta, Georgia)
InnerDyne, (Sunnyvale, California)
Influence (San Francisco, California)
Photoelectron (Lexington, Massachusetts)
Mobile Stereotactic
Biopsy System & Services
UMS (Westborough, Massachusetts)
Mobile Biopsy (Statesville, North Carolina)
Source: The BBI Newsletter

The Journal of the American College of Surgeons disseminated an article at the meeting titled "Image-Detected Breast Cancer: State of the Art Diagnosis and Treatment," which was gathered from the International Breast Cancer Consensus Conference in September. The following points were contained in the summary of conclusions:

1) Percutaneous biopsy is preferred over open surgical procedure as the first biopsy procedure in most patients with image-detected abnormalities.

2) Improvement of care will occur through investigation of new treatment modalities and through the optimal use of existing diagnostic and therapeutic methods.

Also stated in the article: "The panel is intrigued by minimally invasive breast cancer therapy using either percutaneous internal resection to completely remove the tumor or interstitial thermal therapy that destroys the tumor in situ. One or more of these approaches may become effective alternatives to conventional open excision in the future." These statements demonstrate the support of the American College of Surgeons in this new and exciting trend.

Driving the in-office market

Two significant market trends in breast biopsy are the continued shift from open surgical excision to less invasive procedures and the increased use of ultrasound guidance to precisely locate the lesion by surgeons and radiologists. This was substantiated by the overflow attendance by surgeons in the ultrasound courses, as well as the predominant booth traffic at the minimally invasive breast biopsy exhibits. A number of new tools have been designed to assist the surgeon in locating and biopsying a suspicious lesion in the surgeon's office, under local sedation, with a minimally invasive incision that provides a superior cosmetic effect. Although many innovative approaches are being investigated (i.e., RF energy, laser, microwave, cryoablation, etc.) until all the clinical trial data has been analyzed, the clinical benefits and potential disadvantages to each modality remains to be seen (see Table 3).

Table 3: Types of Minimally Invasive Excision/Ablation Systems
Name of Company Type of System Comments

SenoRx RF wire excision Cuts tissue with zero force; no thermal effect
Senolase Diode laser In clinical trials. Expecting 510(k) for fibro adenomas 2002
Vivant Microwave
Artemis Trocar device Licensed from Innerdyne
Sanarus Cryoablation Selling biopsy instrument; expecting approval for ablation of fibroadenomas soon
Rita Medical RF ablation of soft tissue In clinical trials; approved for liver tumors
Rubicor RF thermal Diagnosis and treatment
Celsion Microwave ablation In clinical trials
Neothermia RF excision Conditional 510(k) approval; waiting for clinicals to be completed

Source: The BBI Newsletter

Other new minimally invasive products

Several innovative approaches into the world of minimally invasive surgery were shown on the ACS exhibit floor, serving procedures in gastroenterology, breast, laparoscopic cholysysectomy, wound management and others.

Curon Medical (Sunnyvale, California) displayed two different radiofrequency (RF) energy delivery systems used to remodel dysfunctional sphincter valve tissue. In their first device, approved for marketing by the FDA in April 2000, the Stretta System tightens the sphincter in the lower esophagus that is responsible for esophageal reflux in gastroesophageal reflux disease (GERD) patients. There are approximately 14 million GERD patients in the U.S., and so far about 2,000 of them have had the Stretta treatment.

The Stretta System consists of the Stretta Catheter, which is a disposable, flexible catheter with needle electrodes, and the Curon Control Module. Using these devices, the physician delivers precisely controlled RF energy to create thermal lesions in the muscle of the lower esophageal sphincter (LES). The Stretta Procedure is performed under conscious sedation by gastroenterologists in the endoscopy suite. The Stretta catheter is inserted down the patient s throat to the junction of the esophagus and stomach (GE junction). A balloon is inflated and needle electrodes are deployed from a basket surrounding the balloon into the tissue. RF energy is directed from the control module through the electrodes to create thermal lesions in the vicinity of the LES. When the lesions heal, the barrier function of the LES is improved, resulting in a dramatic reduction in GERD symptoms. In an abstract presented at this year's American College of Gastroenterologists meeting, 97% of patients having had the Stretta procedure were off drugs following the procedure.

Curon's second system – the Secca – is designed to treat fecal incontinence, a condition present in more than 21 million patients, usually caused by childbearing. The Secca procedure uses the same technology and treatment concepts as the Stretta System. Using the control module and a hand-held disposable device, physicians deliver RF energy into the muscle of the anal sphincter to improve its barrier function. U.S. clinical trials began in July 2000, and Curon representatives said they are hopeful for a 2Q02 approval from the FDA to begin marketing this product.

Evolutionary products

Surgicon (Stratford, Connecticut) demonstrated its 5 mm SpringLock Ligation system as an alternative to traditional clip appliers. SpringLock has two ligation points on each ligator, instead of one, which provide additional security. In addition, due to the unique grasping ability of the SpringLock device, it can be used to ligate bleeding vessels or other structures head-on. This capability is unique to SpringLock, and has proven especially useful in closing the gallbladder (or other organs) in cases where it is accidentally punctured, thereby reducing the morbidity associated with bile or bile stone leakage. This type of ligation is especially important when chasing hard-to-find and hard-to-ligate bleeders, commonplace with minimally invasive as well as traditional open surgical procedures.

Perhaps the most important feature of the SpringLock ligation system is that it is a 5 mm device, consistent with surgeons' interest in moving to ever-smaller incisions. Heretofore, 5 mm clip appliers have not been successful in the marketplace and Surgicon hopes to fill this need with its initial product.

Large wound management product

Far from minimally invasive – actually for open, gaping wounds – is the Vacuum Assisted Closure (VAC) device by KCI (San Antonio, Texas). The VAC device assists in wound closure by applying localized negative pressure to the edges of the wound. This negative pressure therapy is applied to a special porous dressing positioned in the wound cavity and helps remove interstitial fluids from the wound.

This therapy is especially helpful for trauma wounds, dehisced incisions, grafts and chronic open wounds. The VAC dressing helps prevent contamination of the wound site from outside bacteria, and provides a moist wound environment while also allowing for enhanced evacuation of excess wound fluid.

KCI is selling about 100 units annually. Dr. Emmanuella Joseph found in a clinical study that vacuum-assisted closure therapy promoted faster healing rates than standard wound management dressings and increased the formation of healthy granulation tissue.

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