The General and Plastic Surgery Devices advisory panel of the FDA in mid-April put the agency in a fairly large regulatory bind by voting against recommending approval of silicone gel breast implants made by Inamed (Santa Barbara, California) and then a day later, apparently reversing itself voting to approve the similar implant products made by Mentor (also Santa Barbara). The FDA will review the results of the panel's mixed recommendations. If it approves either of the companies' implants for commercialization, it will lift a 13-year ban on general use of the devices for cosmetic purposes.

The panel's votes were preceded by contradictory and emotional public and industry testimony on April 12, similar to that presented at other previous hearings and panel meetings: proponents saying that women should have the right to balance the risks vs. benefits of the devices and have access to them; opponents offering anecdotal presentations indicating that the devices rupture and cause a range of systemic illnesses.

The following day, the panel heard a presentation by Inamed and took an oh-so-narrow 5-4 vote against recommending commercialization, a decision greeted by loud applause from those arguing they should not be returned to the market for cosmetic purposes. The vote appeared to be based on the panelists' concerns about a lack of long-term data and the company's proposed changes in the devices, though presented by Inamed as improvements.

But the following day that decision appeared to be contradicted by the panel's 7-2 vote for approval of Mentor's silicone gel implants albeit with a long list of conditions. The vote was doubly surprising since Mentor's data seemed less robust than Inamed's and the panel's questions continued to show similar concern over device rupture and the need for longer-term study. Despite the doubt expressed, more than one panelist called Mentor's short-term data collection "excellent."

Following the votes, Dan Cohen, Inamed's vice president of global government and corporate affairs, called the outcome "bizarre" and "inexplicable." He told The BBI Newsletter, "I am surprised. Some panel members who were demanding longer-term data yesterday accepted shorter-term data today." He also said that he did not expect the panel's vote to block the impending purchase of the company by Medicis (Scottsdale, Arizona), a deal valued at nearly $2.8 billion. "Both companies have products in the pipeline, and there is no time base for when any particular product will be approved, so we do not anticipate that will have any impact on the merger," Cohen said.

Mentor was just as understandably pleased by the vote it received, though it came with a lengthy list of conditions recommended by the panel. These include:

  • Hands-on education sponsored by the company for board-certified plastic surgeons.
  • Additional data collection.
  • Independent data monitoring for ongoing studies.
  • Development by Mentor of a patient education program and consent process.
  • Modified case study to include patients who have had implants extracted and not reimplanted.
  • Making the implants tracked devices by the FDA.
  • Labeling recommendation for MRIs at five years to look for evidence of silent rupture.

With the FDA now having to sort through the panel's recommendations, Mentor and Inamed must proceed in very different ways, Inamed especially wondering what went wrong for it and what apparently went right for Mentor. Cohen said that Inamed will continue to work with the agency to win approval, though declining to predict a timeframe for application re-filing. While calling the panel's votes "curious and inconsistent," Nicholas Teti, president and CEO of Inamed, said in a company statement: "We look forward to working with Dr. [Lester] Crawford [the agency's acting commissioner] and FDA staff on addressing these inconsistencies."

For his part, Josh Levine, president and CEO of Mentor, said, "I think the panel concluded that not all implants are created equally. We're very gratified, but obviously there is still work to do because the FDA has not weighed in yet. If the science is what's focused on, we'll get FDA approval." Levine said he was not concerned by the list of conditions required by the panel and that the company has been working with professional societies to prepare extended follow-up and device registries. "I don't see the conditions as onerous," he noted.

Following the vote supporting Mentor, Diana Zuckerman, president of the National Center for Policy Research for Women and Families (Washington), called the panel's ruling "a triumph of wishful thinking" over science. "Because of all the conditions," she added, "it's far from a done deal regarding the FDA. It's not helpful to women to have a product approved on the basis of two years of safety data."

What comes next? Stay tuned.

DexCom IPO to seek $56 million

The initial public offering (IPO) opportunities in the med-tech sector continue to rebound in 2005. DexCom (San Diego) last month unveiled the number of shares and pricing 4.7 million at $12 a share for a proposed $56 million IPO. The company in February filed for the IPO with the Securities and Exchange Commission (SEC). DexCom also granted the offering underwriters an option to purchase up to another 705,000 shares of over-allotments at the IPO price.

DexCom is developing an implantable system for continuous monitoring of blood glucose as an alternative to blood draws. Its Continuous Glucose Monitoring System includes an implantable sensor that continuously measures glucose levels in subcutaneous tissue and transmits that data wirelessly to an external receiver at specified intervals. The company has said that, "with a push of a button, the receiver displays the patient's current glucose value, as well as one-hour, three-hour and nine-hour trends." The receiver also includes an alert that signals out-of-parameter glucose levels. DexCom has reported "encouraging human clinical data" from the first generation of its system.

In other recent med-tech IPO filings:

CryoCor (San Diego), a developer of technologies to treat cardiac arrhythmias, filed with the SEC for an IPO of up to $46 million, with the number of shares offered and estimated price range not disclosed. The company said that proceeds from the offering would be used to continue product development and ongoing clinical trials, build sales and marketing capabilities, provide working capital and go to other general corporate purposes.

CryoCor's products use cryogenic technology to treat arrhythmia, a disorder of heart rate or rhythm which causes the heart to pump blood less efficiently and can result in a stroke.

ev3 (Plymouth, Minnesota) filed with the SEC, but did not list the number of shares proposed or the pricing. Underwriters of the offering are Piper Jaffray & Co. and Banc of America. ev3 was founded in 2000 by Dale Spencer, an executive experienced in the endovascular device industry, and Warburg Pincus and The Vertical Group. Flying somewhat under the marketing radar, ev3 has been acquiring and developing a variety of catheter-based technologies used in the treatment of coronary, neurological and peripheral vascular diseases.

Its cardiovascular products include the SpideRx, a rapid-exchange filter for embolic protection; the X-Sizer, a thrombus removal system; the Diver C.E., a rapid exchange aspiration catheter; and the PLAATO, for minimally invasive occlusion of the left atrial appendage. It is developing a variety of stents used in the peripheral vasculature: a family of Prot g devices; AqWire, Nitrex and Gooseneck snares; and a family of balloon angioplasty catheters.

In its SEC filing, the company said it is dependent on its Prot g GPS family of peripheral stents, "which generated more than 10% of . . . net sales in fiscal 2004." It said also that in March it received notice from Medtronic Vascular (Santa Rosa, California) that "it believes our Prot g stent infringes on one or more of its patents . . ."

Arrow discontinues LionHeart effort

After nearly a decade of development and millions of dollars invested, Arrow International (Reading, Pennsylvania) said in early April that it would discontinue its LionHeart left ventricular assist system (LVAS) program and focus its resources on the CoreAide continuous flow, ventricular assist device (VAD). It termed the CoreAide a "more promising" product and said its board voted to discontinue development, sales and marketing related to the LionHeart.

Earlier announcements issued by the company may have signaled that the LionHeart program was headed for an early retirement. The company reported about a year ago that it was deferring its U.S. Phase II clinical trial of the LionHeart and was waiting to see how the next generation of the device would fare in the European market, where it received CE-marking in 2003. Arrow originally received FDA approval of an investigational device exemption for a Phase I trial of the system more than three years ago, in early 2001.

While Carl Anderson Jr., chairman and CEO, said that the LionHeart program established "a new level of technological achievement," he said the company concluded that the LionHeart program was not feasible economically after assessing the "time and investment required to maximize the potential of the LionHeart" and that it "would not realize adequate ret-urns for Arrow shareholders in an acceptable period of time."

Arrow will continue the clinical trial of the CoreAide continuous flow ventricular assist device in Europe, the development rights acquired through a licensing agreement with the Cleveland Clinic Foundation (Cleveland) in 2001. The company said it believes the CoreAide's smaller size, less-invasive surgical approach and inherently simpler design offers better opportunities for broader market acceptance. Similar to the Debakey VAD from competitor MicroMed (Houston, Texas), the CoreAide is non-pulsatile and features a magnetically suspended pumping mechanism and uses the moving blood as its lubricating system.

Other companies involved in the VAD sector include A-Med Systems (West Sacramento, California), Thoratec (Pleasanton, California), Vascor (Pittsburgh), VentraCor (Sydney, Australia) and WorldHeart (Oakland, California).