Bedford, MA-based Hologic (NASDAQ: HOLX) announced that the FDA has approved its permanent contraception device, called Adiana. Offering a less-invasive alternative to tubal ligation—a surgical procedure that is one of the most common forms of contraception worldwide—the device can be inserted via catheter through the vagina in a 15-minute procedure. Hologic gained European approval for the device this past January.

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New England’s life sciences firms got a lot of news from the FDA this past week—not all of it good. Here’s more on that, and the rest of the week’s news from the sector.

—Ryan caught up with the CEO of Targanta Therapeutics (NASDAQ:TARG) the day after the FDA has decided to not to approve the Cambridge, MA-based biotech firm’s antibiotic oritavancin. Mark Leuchtenberger says Targanta will need to raise money to fund the clinical trial that the FDA will require the company to conduct before once again considering oritavancin, which would be the firm’s first marketed product, and that Targanta will “take the appropriate steps” to use its existing funds appropriately.

—Another local life sciences firm, Watertown, MA-based Acusphere (NASDAQ:ACUS), also got bad news about its lead product candidate when an FDA advisory panel voted 16-1 against recommending approval of the heart imaging agent known as perflubutane polymer microspheres (Imagify). The FDA is not obligated to follow such advice, but it usually does.

—Cambridge, MA-based Semprus BioSciences reportedly raised $8 million in a Series A financing round led by 5AM Ventures and Pangaea Ventures. Semprus is developing antimicrobial coatings for medical devices.

—Infinity Pharmaceuticals (NASDAQ: INFI) of Cambridge, MA, announced that its partner, AstraZeneca, has decided to give back its share of a program focused on developing cancer drugs that block a target called heat shock protein 90. Luke offered a couple of points of view on what AstraZeneca’s decision means, and how it might affect Infinity.

—Ryan spoke with officials from several of the disease foundations that are an increasingly important source of funding for biotechs such as Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ:VRTX). But with their own budgets being squeezed by the economic downturn, foundations are … Next Page »

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Sure there was a venture funding, some FDA news, and a few interesting alliances last week. But for many members of the Boston-area life sciences community the big news came from Virginia…

—The U.S. District Court for the Eastern District of Virginia blocked a patent-reform package—vehemently opposed by the biotech and pharma industries—that would have limited the number of claims and continuation applications that patent seekers could make. Patent lawyers were still dancing the next day, Xconomist David Resnick told us.

—Cambridge, MA-based Genzyme (NASDAQ: GENZ) pledged about $200 million to expand its manufacturing operation in Waterford, Ireland. The expansion will create 170 highly skilled jobs, according to an announcement from Ireland’s Minister for Enterprise, Trade and Employment.

—Radius Health closed a $28.3 million second tranche of its Series C round. MPM Capital, The Wellcome Trust, HealthCare Ventures, Oxford Bioscience Partners, BB Biotech Ventures, and Scottish Widows Investment Partnership all participated in the deal.

—A new test for the “superbug” methicillin-resistant Staphylococcus aureus (MRSA) won FDA approval. Its manufacturer, Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO), said the test could help healthcare facilities screen their patients.

—Epix Pharmaceuticals (NASDAQ: EPIX) of Lexington, MA, expanded its alliance with the Cystic Fibrosis Foundation. The arrangement, focused on developing drugs that target an errant protein in cystic fibrosis patients, could now be worth more than $50 million for Epix. I did a quick run-down of the many local firms now taking advantage of such “venture philanthropy” deals.

—Waltham, MA-based Repligen (NASDAQ: RGEN) settled a patent suit that it filed with the University of Michigan against Bristol-Myers Squibb (NYSE: BMY). The deal entitles Repligen to an initial $5 million payment, as well as royalties on BMS’s arthritis drug.

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Boston Scientific (NYSE: BSX) announced today that the FDA has approved three of its cardiac products. The news is a bit of a bright spot amidst an ongoing restructuring effort expected to cut some 2,300 jobs at the Natick, MA-based firm, and follows on the heels of the news that it had lost a $431 million patent-infringement suit—a decision the company intends to fight.

All three of the newly approved products come out of Boston Scientifics’ cardiac rhythm management business, which was combined with the company’s electrophysiology business as part of the restructuring plan announced in October. Two of the products—the Confient ICD and the Livian CRT-D—are implantable devices for regulating and defibrillating cardiac patients’ hearts. The third product is an upgraded version of the Latitude patient management system, a wireless system that allows doctors to monitor patients with implanted devices such as the Confient and the Livian in their homes. “These technologies are welcome improvements that are designed to provide earlier insight into changing patient conditions and enable me to devote time to patients who need me the most,” said University of Iowa professor of medicine Brian Olshansky in the Boston Scientific statement.

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A piece of news went out over the wires yesterday that I think deserves a little more explanation: Danvers, MA-based Abiomed announced that it had received a new FDA approval for its AbioCor artificial heart. The item caught my eye because I’ve been loosely following this technology—a fully implantable mechanical heart replacement—since 1999, when I edited Antonio Regalado’s excellent profile in Technology Review of Abiomed’s attempts to commercialize the device. The device, I remembered, was finally approved in September of 2006—so why a new approval now, I wondered?

It turns out, I learned from Abiomed CFO Daniel Sutherby yesterday evening, that despite getting the go-ahead to start selling the device back in 2006, Abiomed never has done so. Instead, he says, the company made the strategic decision to improve the heart’s software and reliability—and what was announced yesterday was an approval of those upgrades.

It’s a rare move for a company to hold back on marketing after working so many years to get a product approved in the first place. (One other recent example is orthopedic-implant firm ConforMIS, which I profiled in November. ) But for Abiomed, I think the cautious approach is the smart one. Artificial hearts have a complicated history, with early trial volunteers Barney Clark and William Schroeder (whose diseased hearts were replaced with a device quite different form Abiomed’s) suffering terribly from clots, strokes, infections, and other side effects. (Regalado’s story lays out more fully how the field’s history affected Abiomed’s initial work on the AbioCor, then known as the PulsaCor.)

In Abiomed’s own human trials of the original AbioCor, begun in 2001, results were mixed. Over the course of several years, the company implanted the device in 14 men whose hearts had failed and whose doctors deemed them ineligible for a transplant and unlikely to live for more than a month. Two of those patients died during the implantation surgery, and two died when the device failed; all of the volunteers had some degree of bleeding complications. But 10 of the patients survived longer than two months, and four of those people were even able to leave the hospital for some activities. Overall, the volunteers survived an average of four and a half months after the surgery, with one patient surviving 512 days.

With the newly approved upgrades, Abiomed believes it has a device that’s finally ready for commercialization. “Now we’re ready to go,” says Sutherby. The approval allows the company to sell up to 4,000 units a year in the United States to heart-failure patients who are ineligible for transplant and unlikely to survive otherwise. At a price of $250,000 per unit, that’s “literally a billion-dollar monopoly,” he says. (Other heart-support devices exist, but the AbioCor is the only one that replaces the whole heart and is fully implanted, without any wires or tubes sticking through the skin.) And that figure doesn’t include additional charges for diagnostic support, clinical support, training, and ancillary technology, he adds.

Sutherby says sales of the device will likely begin in two to three months, after training is complete at the four surgical centers (in Maryland, New Jersey, Texas, and Indiana) that the company has selected for a controlled roll-out of the technology. Abiomed may add an additional U.S. center, he says, and over time may add up to five centers overseas.

The company is also working on a smaller version of the artificial heart, the AbioCor II, that would last up to five years and fit in more patients. (The AbioCor I is too large for the majority of women and for some men.) Clearly this could open the door to a much wider market, but Abiomed is not yet revealing when it will seek approval for the newer version. Says Sutherby, “We want to see AbioCor I work for the patients and for the company first.”

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ConforMIS, a Burlington, MA-based maker of implants for less-invasive knee surgery that I profiled back in November, announced today that it has received European regulatory approval for the second of its four types of implants, as well as the specialized instruments for implanting the device. ConforMIS’s products are already approved in the U.S.

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Biogen Idec (NASDAQ: BIIB) of Cambridge, MA, and Ireland’s Elan announced this afternoon that the FDA has granted an expanded approval for their drug Tysabri as a treatment for Crohn’s disease. The drug was previously approved to treat multiple sclerosis.

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