By AMANDA PEDERSEN
CD&D Staff Writer
and Staff Reports
Less than a year after receiving the FDA go-ahead to sell its Merci L6 Retriever and about four years after the agency cleared its original Merci Retriever Concentric Medical (Mountain View, California) has launched its V series Merci Retrievers in the U.S.
These new Retrievers, available in multiple configurations and sizes to match patient anatomy, join Concentric's existing Merci Retrievers already on the market, and provide physicians with additional options for restoring blood flow in patients who have suffered ischemic strokes, the company said.
In August 2004, the original Merci Retriever became the first device cleared by FDA to remove blood clots from the brain in patients experiencing an ischemic stroke. The device is a catheter that contains a coil-shaped wire that resembles a corkscrew.
According to Concentric, the V series Retrievers have been designed to be the most efficient Merci Retrievers yet and are "the culmination of the company's many years of experience providing neurovascular retrievers for ischemic stroke patients."
The distal end of the latest Retriever is tightly coiled, which resists stretching and assists in dislodging clots, Concentric said. The proximal end of the V series Retrievers is more loosely coiled, which facilitates wrapping and holding a dislodged clot. Similar to Concentric's L family of Retrievers, the V series of Merci Retrievers incorporate filaments that provide an additional mechanism for securing blood clots during retrieval from the brain.
The V series of Retrievers will be available in diameters of 2.0 mm, 2.5 mm and 3.0 mm.
FDA cleared Concentric's Merci L6 Retriever in September 2007.
An ischemic stroke occurs when a blood vessel in the brain is blocked by a blood clot, which can impair brain function, thus differentiated from a hemorrhagic stroke, which results from a ruptured blood vessel or arterio-venous malformation. Of the 700,000 annual strokes in the U.S., about 87% are ischemic, according to Concentric.
"The Merci Retrieval System is the most widely used clot retrieval system for ischemic stroke, and we continue to incorporate the knowledge gained from our experience, as well as input from many clinicians, into improved devices," said President/CEO Maria Sainz. "These next-generation Retrievers are further evidence of our leadership in bringing exciting and new life-saving options to stroke patients."
The Merci Retriever is made with a flexible, shaped nitinol wire that allows delivery of the Retriever in linear form using standard catheterization techniques. A neurointerventionalist makes a small puncture in the groin to introduce the Merci Retriever into an artery leading to the brain. The Merci Retriever returns to its original shape when deployed in and around the blood clot in the brain.
Concentric's competition in this space includes Ekos (Bothell, Washington), which just last week launched its EkoSonic endovascular system with Rapid Pulse Modulation intended to provide a safer, faster and more complete way to remove dangerous blood clots. The device can deliver microsonic energy and thrombolytic drugs simultaneously, with no evidence of thrombus breakage or hemolysis, according to Ekos (MDD, July 22, 2008).
Not-so-NICE rejection of Cordis appeal
An appeal by Cordis (Miami Lakes, Florida) regarding the methodology used in setting guidelines for the use of drug-eluting stents (DES) for the treatment of coronary artery disease in the UK has been turned down and the final guidance, which fixes reimbursement for stents from the National Health Service (NHS), now goes into effect.
In February, England's National Institute for Health and Clinical Excellence (NICE) issued draft guidelines that cleared the way for the reimbursement of DES in what is estimated to be a $100 million market.
That decision reversed an earlier position taken by NICE in August 2007, when it published draft guidance saying DES does not "represent a cost-effective use of National Health Service resources" when compared to bare-metal stents (BMS).
According to Andrew Dillon, chief executive at NICE, "The guidance is the result of careful consideration of the evidence, as well as comments received during consultation and further economic modeling."
He added, "This decision to recommend the use of drug-eluting stents will ensure that, despite their higher cost, they will continue to be an important treatment option for patients who would be at high risk of requiring further interventions if a bare-metal stent was used instead."
The guidance recommends the use of drug-eluting stents for patients who are at high risk of requiring further interventions if a conventional bare-metal stent were used instead.
NICE clinical practice guidelines define such patients as having a coronary artery less than 3 mm in diameter, or where the segment of the artery to be treated is longer than 15 mm.
The guidance also states that drug-eluting stents should be used only if the price difference between it and a bare-metal stent is no more than £300 ($595).
Cordis' appeal of the Final Appraisal Determination (FAD) centers on this price difference, and the modeling used to determine the economic benefits for DES vs. BMS.
The objections from Cordis were that NICE failed to act fairly in accordance with its published procedures, that the institute exceeded its powers, and that the guidance is "perverse in the light of the evidence submitted."
In its appeal, Cordis argued DES cost-effectiveness "is largely insensitive to BMS price," saying DES in the price premium range of £400 to £450 ($795 to $894) are cost-effective regardless of a BMS price.
"It is perverse for the Appraisal Committee to recommend a price premium of no more than £300, equivalent to less than £5,000 quality-adjusted life-year (QALY), when premiums of £400-£450 result in incremental cost-effectiveness ratios (ICERs) within the institute's cost effectiveness range of £20,000-£30,000/QALY," said the Johnson & Johnson (New Brunswick, New Jersey) unit.
Saying there "is no legitimate reason for NICE to impose a maximum price premium of £300," which is "an unprecedented step," Cordis insisted that if the institute persists in this approach, the premium should be expressed as a price range and not a fixed target.
Cordis' recommendation to replace the £300 point with the statement "in the range of £400 to £450" was not adopted by NICE.
NICE holds a government charter for independent review of clinical practices, which in turn becomes directly linked to NHS reimbursement.
Other European governments and insurers, such as Germany's 300-plus health funds, closely follow the NICE guidance and best-practice recommendations.
Angiotech creates new subsidiary
In a two-pronged effort, specialty pharmaceutical and medical device firm Angiotech Pharmaceuticals (Vancouver, British Columbia) said early last month that it had begun a $165 million tender offer to buy back of its outstanding notes and also reported that it is creating a new subsidiary, Angiotech Pharmaceuticals Interventions (API), with an investment of up to $300 million from Ares Management and New Leaf Venture Partners.
Angiotech said the closing of the tender offer was conditioned upon the closing of the investment in API, and shareholder approval of that investment.
Angiotech said the new subsidiary would hold most of its assets outside of its Taxus coronary stent business, a product sold by Boston Scientific (Natick, Massachusetts) for which Angiotech provides the paclitaxel drug coating.
Boston Sci is facing increased competition in the drug-eluting stent market, with Abbott (Abbott Park, Illinois) having just received FDA approval of its Xience V everolimus-eluting coronary stent, making it the second of the 2.0 family of drug-eluting stents to win marketing approval in the U.S. (see story).
Angiotech's tender offer is scheduled to expire at midnight, EDT, Aug. 22, unless extended or earlier terminated. The company said the settlement date is expected to be Aug. 26.
Other Angiotech news last month included its report that the British House of Lords has confirmed the validity of one of its patents for a drug coating on devices to prop open arteries, ending a nine-year European legal battle.
The company said that Britain's highest court had overturned the rulings of the lower courts that claimed the patent issued to Angiotech by the European Patent Office for its paclitaxel stent coating was invalid.
Rival stent maker Conor Medsystems (Menlo Park, California) and four other companies had launched various challenges to the validity of Angiotech's patent.
The Angiotech drug coating inhibits the division of cells and prevents migration, discouraging cells with destructive potential from migrating and accumulating at the injured site.
Both the UK trial court and the UK Court of Appeal had ruled that the patent was invalid based on the data of several publications.
However, the House of Lords ruled against the decisions of the lower courts noting that it "did not agree with the reasoning that the lower courts had used in justifying revocation." Instead it based its argument on an earlier Dutch decision.
"We are pleased that the House of Lords entered final judgment in Angiotech's favor and view this outcome as further proof of the continued strength of our paclitaxel stent patent portfolio throughout the world," Angiotech President /CEO Bill Hunter said in a statement.
$325M VC fund is closed
Longitude Capital (Menlo Park, California) in early July reported the closing of its first investment vehicle, Longitude Venture Partners, a $325 million venture capital fund dedicated to life sciences investments. The fund exceeded its target of $250 million, the company said.
The team at Longitude Capital includes managing directors Juliet Tammenoms Bakker, Patrick Enright and Marc-Henri Galletti, venture partner Jeffrey Gold, principals Douglas Foster and David Hirsch, and CFO Elaine Erickson. The firm was formed following the team's spin-out from Pequot Capital, where they were responsible for venture capital investments in life sciences companies since 1997.
"We have a strong team and a unique style of investing that has produced excellent returns over multiple fund vintages," said Bakker, Longitude co-founder and managing director. "As has been the case in the past, we are active investors across all sectors and stages but tend to favor earlier-stage medical device companies and later-stage opportunities in biotech."
Prior to forming Longitude, the team was collectively responsible for more than 100 venture capital investments in the life sciences. Representative investments include Ablation Frontiers, Acufocus, Align Technology, Cephalon, Codexis, CryoVascular Systems, Embolic Protection, eyeonics, Eyetech Pharmaceuticals, Horizon Therapeutics, Insulet, MAP Pharmaceuticals, Oratec, Prestwick Pharmaceuticals, Sequenom and Sugen.
The team's experience spans all stages of companies in most therapeutic areas within the medical device and biotechnology sectors.
"In addition to traditional venture capital investments, we will also pursue special situations including PIPEs, recaps and spin-outs," said Enright, Longitude co-founder and managing director. "Our research-intensive approach often leads us into areas that are contrarian, undercapitalized or otherwise out of favor."
UBS Securities acted as placement agent and financial advisor to Longitude Capital in connection with the offering.
"We are very pleased that Longitude Venture Partners exceeded its target offering size and is one of the largest first-time funds ever raised in the life sciences sector," said David Webb, executive director of UBS Securities.
EP MedSystems now in St. Jude fold
St. Jude Medical (St. Paul, Minnesota) said last month that it had completed its acquisition of EP MedSystems (West Berlin, New Jersey) and reported the final allocation of cash and stock to EP shareholders in connection with the deal.
St. Jude agreed to pay about $91 million, consisting of some $54,558,607 in cash and about 898,000 shares of St. Jude stock. St. Jude's board also approved an additional $50 million stock buyback authorization, which will offset the shares issued in the transaction.
As previously reported, EP shareholders will receive either $3 in cash or 0.0738 shares of St. Jude common stock for each share of EP common stock, subject to proration so that 60% of the EP shares are exchanged for cash and 40% are exchanged for shares of St. Jude common stock.
The election results indicated that of the 30,354,236 shares of EP common stock outstanding immediately prior to closing of the transaction 21,611,763 shares, or about 71.19%, elected to receive cash and will be subject to proration, receiving roughly 84.15% of their total consideration in cash and the rest in St. Jude stock; 4,324,046 shares, or about 14.25%, elected to receive shares of St. Jude stock and will receive such share consideration in full; and 4,418,427 shares, or roughly 14.56%, did not make a valid election, and those EP shareholders will receive all of their consideration in St. Jude stock.
EP develops a broad line of products for use in the cardiac rhythm management or electrophysiology market.